Human protein
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Featuring an interview with Dr Rinath M Jesselsohn, including the following topics: Evaluating first-line treatment of metastatic ER-positive, HER2-positive breast cancer: heredERA Breast Cancer study (0:00) Kuemmel S et al. heredERA Breast Cancer: A phase III, randomized, open-label study evaluating the efficacy and safety of giredestrant plus the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with previously untreated HER2-positive, estrogen receptor-positive locally advanced or metastatic breast cancer. BMC Cancer 2024;24(1):641. Abstract Treatment outcomes with CDK4/6 inhibitors and with elacestrant in real-world studies (4:13) Lloyd MR et al. CDK4/6 inhibitor efficacy in ESR1-mutant metastatic breast cancer. NEJM Evid 2024;3(5). Abstract Lloyd M et al. Impact of prior treatment, ESR1 mutational (ESR1m) landscape, and co-occurring PI3K pathway status on real-world (RW) elacestrant outcomes in patients (pts) with hormone receptor-positive (HR+)/HER2-negative advanced breast cancer (aBC). San Antonio Breast Cancer Symposium 2024;Abstract PS7-05. Evaluating the CNS activity of imlunestrant, an oral selective estrogen receptor degrader (SERD) (8:06) VandeKopple M et al. Preclinical characterization of imlunestrant, an oral brain-penetrant selective estrogen receptor degrader with activity in a brain metastasis (BM) model. ESMO Breast 2023;Abstract 41P. Selective review of trials of oral SERDs in the adjuvant setting (11:27) A study of imlunestrant versus standard endocrine therapy in participants with early breast cancer (EMBER-4). NCT05514054 CME information and select publications
This featured podcast includes a discussion with 3 experts on managing patients with hormone receptor–positive/HER2-negative (HR+/HER2–) metastatic breast cancer (mBC) from a satellite symposium held in conjunction with the 42nd Annual Miami Breast Cancer Conference® in March 2025. In observational studies of treatment patterns in older women with mBC, approximately half of the patients were undertreated, and only half received a CDK4/6 inhibitor (CDK4/6i)-based regimen in the first-line setting. Reasons for undertreatment include concerns about the patient's age, perceived frailty, and underlying health issues. Aging is a heterogeneous process; older patients must receive individualized treatment that is not based solely on their age but on a comprehensive assessment that objectively assesses their overall health and ability to tolerate treatment. This program is designed to help clinicians assess the fitness of older patients with HR+/HER2– mBC, review the efficacy and safety of CDK4/6i in this patient population, and individualize treatment decision-making appropriately. Acknowledgment of Educational Grant Support This activity is supported by an educational grant from Pfizer Inc. Today's faculty are: Hope S. Rugo, MD Director, Women's Cancers Program Division Chief, Breast Medical Oncology Professor, Department of Medical Oncology & Therapeutics Research City of Hope Comprehensive Cancer Center Duarte, CA Professor Emeritus, UCSF Disclosures: Grant/Research Support: Ambrx; AstraZeneca; Daiichi Sankyo, Inc; F. Hoffmann-La Roche AG/Genentech, Inc; Gilead Sciences, Inc; Lilly; Merck & Co., Inc; Novartis Pharmaceuticals Corporation; OBI Pharma; Pfizer; Stemline Therapeutics. Consultant: Napo Therapeutics; Puma Biotechnology; Sanofi. Honoraria: Chugai; Mylan/Viatris. Neil M. Iyengar, MD Associate Attending, Breast Medicine Service Program Lead, MSK Healthy Living Department of Medicine Memorial Sloan Kettering Cancer Center Associate Professor of Medicine Weill Cornell Medical College New York, NY Disclosures: Consultant/Adviser: Arvinas, AstraZeneca, BD Life Sciences, Daiichi Sankyo, Genentech/Roche, Gilead, Menarini-Stemline, Novartis, Pfizer, Puma, Seagen, TerSera Therapeutics. Speaker: Cardinal Health, Curio Sciences, DAVA Oncology, IntrinsiQ Health. Editorial Position: npj Breast Cancer, Oncology®. Equity/Ownership: Complement Theory, Bettering Company. Research Support (to institution): American Cancer Society, Breast Cancer Research Foundation, Conquer Cancer Foundation, Kat's Ribbon of Hope, National Cancer Institute/National Institutes of Health. Contracted Research: Novartis, SynDevRx. Komal Jhaveri, MD, FACP Patricia and James Cayne Chair for Junior Faculty Associate Attending Physician, Breast Medicine Service and Early Drug Development Service Section Head, Endocrine Therapy Research Program Clinical Director, Early Drug Development Service Memorial Sloan Kettering Cancer Center Associate Professor of Clinical Medicine Weill Cornell Medical College New York, NY Disclosures: Consultant/Advisory Board: AbbVie Inc, AstraZeneca Pharmaceuticals LP, Blueprint Medicines, Bristol Myers Squibb, Daiichi Sankyo Inc, Eisai Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Jounce Therapeutics, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Menarini Group, Novartis, Olema Oncology, Pfizer Inc, Scorpion Therapeutics, Seagen Inc, Stemline Therapeutics Inc, Sun Pharma Advanced Research Company Ltd, Taiho Oncology Inc. Research Funding: AstraZeneca Pharmaceuticals LP, Debiopharm, Genentech, a member of the Roche Group, Gilead Sciences Inc, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Merck, Novartis, Pfizer Inc, Puma Biotechnology Inc, Scorpion Therapeutics, Zymeworks Inc. The staff of Physicians' Education Resource®, LLC, have no relevant financial relationships with ineligible companies. PER® mitigated all COI for faculty, staff, and planners prior to the start of this activity by using a multistep process. Off-Label Disclosure and Disclaimer This activity may or may not discuss investigational, unapproved, or off-label use of drugs. Learners are advised to consult prescribing information for any products discussed. The information provided in this accredited activity is for continuing education purposes only and is not meant to substitute for the independent clinical judgment of a health care professional relative to diagnostic, treatment, or management options for a specific patient's medical condition. The opinions expressed in the content are solely those of the individual faculty members and do not reflect those of PER® or any company that provided commercial support for this activity.
Featuring perspectives from Prof Rebecca A Dent and Dr Nancy U Lin, including the following topics: Introduction: A New Paradigm for Triple-Positive Breast Cancer? (0:00) CDK4/6 Inhibitors for HR-Positive, HER2-Negative Breast Cancer (10:06) Oral Selective Estrogen Receptor Degraders for HR-Positive, HER2-Negative Breast Cancer (21:17) Treatment of PIK3CA/PTEN/AKT-Mutated Breast Cancer (31:34) Antibody-Drug Conjugates (ADCs) for HR-Positive, HER2-Negative Breast Cancer (38:41) ADCs for HER2-Positive Breast Cancer (46:30) HER2-Targeting Tyrosine Kinase Inhibitors for HER2-Positive Breast Cancer (53:26) ADCs for Advanced Triple-Negative Breast Cancer (58:29) CME information and select publications
Featuring a slide presentation and related discussion from Dr Adam M Brufsky, including the following topics: Mechanism of action of and long-term data with CDK4/6 inhibitors in the management of metastatic breast cancer (mBC) (0:00) Comparing safety profiles of CDK4/6 inhibitors (9:49) Role of CDK4/6 inhibitors in therapy for older patients with mBC (24:06) Real-world evidence with CDK4/6 inhibitors (27:31) CME information and select publications
Featuring perspectives from Dr Aditya Bardia, Dr Virginia F Borges, Dr Harold J Burstein and Dr Joyce O'Shaughnessy, including the following topics: Introduction (0:00) HER2-Positive Breast Cancer — Dr O'Shaughnessy (3:13) Triple-Negative Breast Cancer — Dr Bardia (32:56) Personalizing Adjuvant Therapy for Patients with HR-Positive Breast Cancer — Dr Borges (57:35) Current Role of CDK4/6 Inhibitors in the Localized Setting — Dr Burstein (1:25:15) CME information and select publications
Can people diagnosed with metastatic hormone receptor-positive breast cancer avoid chemotherapy and take a CDK4/6 inhibitor instead? Do people diagnosed with DCIS need to have surgery? Will there soon be another oral selective estrogen degrader available? Breastcancer.org medical advisor Dr. Kevin Fox explains the details of the studies and what they mean for you. Listen to the episode to hear Dr. Fox discuss these studies: Young-PEARL: Ibrance plus Aromasin, along with ovarian suppression, offers better progression-free survival than Xeloda for pre-menopausal women with metastatic hormone receptor-positive, HER2-negative breast cancer who had previously received tamoxifen. PATINA: Adding Ibrance to standard-of-care first treatments for metastatic hormone receptor-positive, HER2-positive breast cancer increased progression-free survival by more than a year. EMBER-3:Imlunestrant led to longer progression-free survival than standard therapy if the cancer had an ESR1 mutation among people with estrogen receptor-positive, HER2-negative advanced-stage breast cancer. Adding Verzenio to imlunestrant improved progression-free survival compared to imlunestrant alone, whether the cancer had an ESR1-mutation or not. COMET: Can people with low-risk DCIS just be monitored instead of having surgery with or without radiation?
Featuring an interview with Dr Raajit K Rampal, including the following topics: Clinical decision-making in the initiation and stopping of systemic therapy for myelofibrosis (MF) (0:00) Novel research strategies involving CDK4/6 inhibitors for MF (8:03) Implications of the JUMP study for clinical practice (10:00) Therapeutic switching strategies with JAK inhibitors for MF (12:17) Clinical rationale for the use of luspatercept and elritercept for MF (15:35) Emerging clinical data involving BET inhibitors for MF (16:57) Tolerability concerns with selinexor in patients with MF (20:01) Mechanism of and clinical data with the MDM2 inhibitor navtemadlin for MF (22:32) Additional novel strategies under clinical investigation for MF (25:52) Potential transformation of myeloproliferative neoplasms to acute myeloid leukemia (29:40) Management of polycythemia vera and essential thrombocythemia (34:27) General management principles for myeloproliferative neoplasms (37:53) CME information and select publications
Featuring perspectives from Dr Aditya Bardia, Dr Virginia F Borges, Dr Harold J Burstein and Dr Joyce O'Shaughnessy, including the following topics: Introduction (0:00) CDK4/6 Inhibitors for HR-Positive Metastatic Breast Cancer (mBC) — Dr Borges (9:56) Targeting the PTEN/PI3K/AKT Pathway in HR-Positive mBC — Dr Burstein (35:20) Role of Oral Selective Estrogen Receptor Degraders in the Management of HR-Positive mBC — Dr O'Shaughnessy (1:03:07) Antibody-Drug Conjugates for HR-Positive mBC — Dr Bardia (1:36:12) CME information and select publications
Dr. Ko Un “Clara” Park and Dr. Mylin Torres present the latest evidence-based changes to the SLNB in early-stage breast cancer guideline. They discuss the practice-changing trials that led to the updated recommendations and topics such as when SLNB can be omitted, when ALND is indicated, radiation and systemic treatment decisions after SLNB omission, and the role of SLNB in special circumstances. We discuss the importance of shared decision-making and other ongoing and future de-escalation trials that will expand knowledge in this space. Read the full guideline update, “Sentinel Lymph Node Biopsy in Early-Stage Breast Cancer: ASCO Guideline Update” at www.asco.org/breast-cancer-guidelines. TRANSCRIPT This guideline, clinical tools, and resources are available at http://www.asco.org/breast-cancer-guidelines. Read the full text of the guideline and review authors' disclosures of potential conflicts of interest in the Journal of Clinical Oncology, https://ascopubs.org/doi/10.1200/JCO-25-00099 Brittany Harvey: Hello and welcome to the ASCO Guidelines podcast, one of ASCO's podcasts delivering timely information to keep you up to date on the latest changes, challenges and advances in oncology. You can find all the shows, including this one at asco.org/podcasts. My name is Brittany Harvey and today I'm interviewing Dr. Ko Un "Clara" Park from Brigham and Women's Hospital, Dana-Farber Cancer Institute, and Dr. Mylin Torres from Glenn Family Breast Center at Winship Cancer Institute of Emory University, co-chairs on “Sentinel Lymph Node Biopsy in Early-Stage Breast Cancer: ASCO Guideline Update.” Thank you for being here today, Dr. Park and Dr. Torres. Dr. Mylin Torres: Thank you, it's a pleasure to be here. Brittany Harvey: And before we discuss this guideline, I'd like to note that ASCO takes great care in the development of its guidelines and ensuring that the ASCO Conflict of Interest Policy is followed for each guideline. The disclosures of potential conflicts of interest for the guideline panel, including Dr. Torres and Dr. Park, who have joined us here today, are available online with the publication of the guideline in the Journal of Clinical Oncology, which is linked in the show notes. To start us off, Dr. Torres, what is the scope and purpose of this guideline update on the use of sentinel lymph node biopsy in early-stage breast cancer? Dr. Mylin Torres: The update includes recommendations incorporating findings from trials released since our last published guideline in 2017. It includes data from nine randomized trials comparing sentinel lymph node biopsy alone versus sentinel lymph node biopsy with a completion axillary lymph node dissection. And notably, and probably the primary reason for motivating this update, are two trials comparing sentinel lymph node biopsy with no axillary surgery, all of which were published from 2016 to 2024. We believe these latter two trials are practice changing and are important for our community to know about so that it can be implemented and essentially represent a change in treatment paradigms. Brittany Harvey: It's great to hear about these practice changing trials and how that will impact these recommendation updates. So Dr. Park, I'd like to start by reviewing the key recommendations across all of these six overarching clinical questions that the guideline addressed. So first, are there patients where sentinel lymph node biopsy can be omitted? Dr. Ko Un "Clara" Park: Yes. The key change in the current management of early-stage breast cancer is the inclusion of omission of sentinel lymph node biopsy in patients with small, less than 2 cm breast cancer and a negative finding on preoperative axillary ultrasound. The patients who are eligible for omission of sentinel lymph node biopsy according to the SOUND and INSEMA trial are patients with invasive ductal carcinoma that is size smaller than 2 cm, Nottingham grades 1 and 2, hormone receptor-positive, HER2-negative in patients intending to receive adjuvant endocrine therapy, and no suspicious lymph nodes on axillary ultrasound or if they have only one suspicious lymph node, then the biopsy of that lymph node is benign and concordant according to the axillary ultrasound findings. The patients who are eligible for sentinel lymph node biopsy omission according to the SOUND and INSEMA trials were patients who are undergoing lumpectomy followed by whole breast radiation, especially in patients who are younger than 65 years of age. For patients who are 65 years or older, they also qualify for omission of sentinel lymph node biopsy in addition to consideration for radiation therapy omission according to the PRIME II and CALGB 9343 clinical trials. And so in those patients, a more shared decision-making approach with the radiation oncologist is encouraged. Brittany Harvey: Understood. I appreciate you outlining that criteria for when sentinel lymph node biopsy can be omitted and when shared decision making is appropriate as well. So then, Dr. Torres, in those patients where sentinel lymph node biopsy is omitted, how are radiation and systemic treatment decisions impacted? Dr. Mylin Torres: Thank you for that question. I think there will be a lot of consternation brought up as far as sentinel lymph node biopsy and the value it could provide in terms of knowing whether that lymph node is involved or not. But as stated, sentinel lymph node biopsy actually can be safely omitted in patients with low risk disease and therefore the reason we state this is that in both SOUND and INSEMA trial, 85% of patients who had a preoperative axillary ultrasound that did not show any signs of a suspicious lymph node also had no lymph nodes involved at the time of sentinel node biopsy. So 85% of the time the preoperative ultrasound is correct. So given the number of patients where preoperative ultrasound predicts for no sentinel node involvement, we have stated within the guideline that radiation and systemic treatment decisions should not be altered in the select patients with low risk disease where sentinel lymph node biopsy can be omitted. Those are the patients who are postmenopausal and age 50 or older who have negative findings on preoperative ultrasound with grade 1 or 2 disease, small tumors less than or equal to 2 cm, hormone receptor-positive, HER2-negative breast cancer who undergo breast conserving therapy. Now, it's important to note in both the INSEMA and SOUND trials, the vast majority of patients received whole breast radiation. In fact, within the INSEMA trial, partial breast irradiation was not allowed. The SOUND trial did allow partial breast irradiation, but in that study, 80% of patients still received whole breast treatment. Therefore, the preponderance of data does support whole breast irradiation when you go strictly by the way the SOUND and INSEMA trials were conducted. Notably, however, most of the patients in these studies had node-negative disease and had low risk features to their primary tumors and would have been eligible for partial breast irradiation by the ASTRO Guidelines for partial breast treatment. So, given the fact that 85% of patients will have node-negative disease after a preoperative ultrasound, essentially what we're saying is that partial breast irradiation may be offered in these patients where omission of sentinel node biopsy is felt to be safe, which is in these low risk patients. Additionally, regional nodal irradiation is something that is not indicated in the vast majority of patients where omission of sentinel lymph node biopsy is prescribed and recommended, and that is because very few of these patients will actually end up having pathologic N2 disease, which is four or more positive lymph nodes. If you look at the numbers from both the INSEMA and the SOUND trial, the number of patients with pathologic N2 disease who did have their axilla surgically staged, it was less than 1% in both trials. So, in these patients, regional nodal irradiation, there would be no clear indication for that more aggressive and more extensive radiation treatment. The same principles apply to systemic therapy. As the vast majority of these patients are going to have node-negative disease with a low risk primary tumor, we know that postmenopausal women, even if they're found to have one to three positive lymph nodes, a lot of the systemic cytotoxic chemotherapy decisions are driven by genomic assay score which is taken from the primary tumor. And therefore nodal information in patients who have N1 disease may not be gained in patients where omission of sentinel lymph node biopsy is indicated in these low risk patients. 14% of patients have 1 to 3 positive lymph nodes in the SOUND trial and that number is about 15% in the INSEMA trial. Really only the clinically actionable information to be gained is if a patient has four or more lymph nodes or N2 disease in this low risk patient population. So, essentially when that occurs it's less than 1% of the time in these patients with very favorable primary tumors. And therefore we thought it was acceptable to stand by a recommendation of not altering systemic therapy or radiation recommendations based on omission of sentinel nodes because the likelihood of having four more lymph nodes is so low. Dr. Ko Un "Clara" Park: I think one thing to add is the use of CDK4/6 inhibitors to that and when we look at the NATALEE criteria for ribociclib in particular, where node-negative patients were included, the bulk majority of the patients who were actually represented in the NATALEE study were stage III disease. And for stage I disease to upstage into anatomic stage III, that patient would need to have pathologic N2 disease. And as Dr. Torres stated, the rate of having pathologic N2 disease in both SOUND and INSEMA studies were less than 1%. And therefore it would be highly unlikely that these patients would be eligible just based on tumor size and characteristics for ribociclib. So we think that it is still safe to omit sentinel lymph node biopsy and they would not miss out, if you will, on the opportunity for CDK4/6 inhibitors. Brittany Harvey: Absolutely. I appreciate you describing those recommendations and then also the nuances of the evidence that's underpinning those recommendations, I think that's important for listeners. So Dr. Park, the next clinical question addresses patients with clinically node negative early stage breast cancer who have 1 or 2 sentinel lymph node metastases and who will receive breast conserving surgery with whole breast radiation therapy. For these patients, is axillary lymph node dissection needed? Dr. Ko Un "Clara" Park: No. And this is confirmed based on the ACOSOG Z0011 study that demonstrated in patients with 1 to 3 positive sentinel lymph node biopsy when the study compared completion axillary lymph node dissection to no completion axillary lymph node dissection, there was no difference. And actually, the 10-year overall survival as reported out in 2017 and at a median follow up of 9.3 years, the overall survival again for patients treated with sentinel lymph node biopsy alone versus those who were treated with axillary lymph node dissection was no different. It was 86.3% in sentinel lymph node biopsy versus 83.6% and the p-value was non-inferior at 0.02. And so we believe that it is safe for the select patients who are early stage with 1 to 2 positive lymph nodes on sentinel lymph node biopsy, undergoing whole breast radiation therapy to omit completion of axillary lymph node dissection. Brittany Harvey: Great, I appreciate you detailing what's recommended there as well. So then, to continue our discussion of axillary lymph node dissection, Dr. Torres, for patients with nodal metastases who will undergo mastectomy, is axillary lymph node dissection indicated? Dr. Mylin Torres: It's actually not and this is confirmed by two trials, the AMAROS study as well as the SENOMAC trial. And in both studies, they compared a full lymph node dissection versus sentinel lymph node biopsy alone in patients who are found to have 1 to 2 positive lymph nodes and confirmed that there was no difference in axillary recurrence rates, overall survival or disease-free survival. What was shown is that with more aggressive surgery completion axillary lymph node dissection, there were higher rates of morbidity including lymphedema, shoulder pain and paresthesias and arm numbness, decreased functioning of the arm and so there was only downside to doing a full lymph node dissection. Importantly, in both trials, if a full lymph node dissection was not done in the arm that where sentinel lymph node biopsy was done alone, all patients were prescribed post mastectomy radiation and regional nodal treatment and therefore both studies currently support the use of post mastectomy radiation and regional nodal treatment when a full lymph node dissection is not performed in these patients who are found to have N1 disease after a sentinel node biopsy. Brittany Harvey: Thank you. And then Dr. Park, for patients with early-stage breast cancer who do not have nodal metastases, can completion axillary lymph node dissection be omitted? Dr. Ko Un "Clara" Park: Yes, and this is an unchanged recommendation from the earlier ASCO Guidelines from 2017 as well as the 2021 joint guideline with Ontario Health, wherein patients with clinically node-negative early stage breast cancer, the staging of the axilla can be performed through sentinel lymph nodal biopsy and not completion axillary lymph node dissection. Brittany Harvey: Understood. So then, to wrap us up on the clinical questions here, Dr. Park, what is recommended regarding sentinel lymph node biopsy in special circumstances in populations? Dr. Ko Un "Clara" Park: One key highlight of the special populations is the use of sentinel lymph node biopsy for evaluation of the axilla in clinically node negative multicentric tumors. While there are no randomized clinical trials evaluating specifically the role of sentinel lymph nodal biopsy in multicentric tumors, in the guideline, we highlight this as one of the safe options for staging of the axilla and also for pregnant patients, these special circumstances, it is safe to perform sentinel lymph node biopsy in pregnant patients with the use of technetium - blue dye should be avoided in this population. In particular, I want to highlight where sentinel lymph node biopsy should not be used for staging of the axilla and that is in the population with inflammatory breast cancer. There are currently no studies demonstrating that sentinel lymph node biopsy is oncologically safe or accurate in patients with inflammatory breast cancer. And so, unfortunately, in this population, even after neoadjuvant systemic therapy, if they have a great response, the current guideline recommends mastectomy with axillary lymph node dissection. Brittany Harvey: Absolutely. I appreciate your viewing both where sentinel lymph node can be offered in these special circumstances in populations and where it really should not be used. So then, Dr. Torres, you talked at the beginning about how there's been these new practice changing trials that really impacted these recommendations. So in your view, what is the importance of this guideline update and how does it impact both clinicians and patients? Dr. Mylin Torres: Thank you for that question. This update and these trials that inform the update represent a significant shift in the treatment paradigm and standard of care for breast cancer patients with early-stage breast cancer. When you think about it, it seems almost counterintuitive that physicians and patients would not want to know if a lymph node is involved with cancer or not through sentinel lymph node biopsy procedure. But what these studies show is that preoperative axillary ultrasound, 85% of the time when it's negative, will correctly predict whether a sentinel lymph node is involved with cancer or not and will also be negative. So if you have imaging that's negative, your surgery is likely going to be negative. Some people might ask, what's the harm in doing a sentinel lymph node biopsy? It's important to recognize that upwards of 10% of patients, even after sentinel lymph node biopsy will develop lymphedema, chronic arm pain, shoulder immobility and arm immobility. And these can have a profound impact on quality of life. And if there is not a significant benefit to assessing lymph nodes, particularly in someone who has a preoperative axillary ultrasound that's negative, then why put a patient at risk for these morbidities that can impact them lifelong? Ideally, the adoption of omission of sentinel lymph node biopsy will lead to more multidisciplinary discussion and collaboration in the preoperative setting especially with our diagnostic physicians, radiology to assure that these patients are getting an axillary ultrasound and determine how omission of sentinel lymph node biopsy may impact the downstream treatments after surgery, particularly radiation and systemic therapy decisions, and will be adopted in real world patients, and how clinically we can develop a workflow where together we can make the best decisions for our patients in collaboration with them through shared decision making. Brittany Harvey: Absolutely. It's great to have these evidence-based updates for clinicians and patients to review and refer back to. So then finally, Dr. Park, looking to the future, what are the outstanding questions and ongoing trials regarding sentinel lymph node biopsy in early-stage breast cancer? Dr. Ko Un "Clara" Park: I think to toggle on Dr. Torres's comment about shared decision making, the emphasis on that I think will become even more evident in the future as we incorporate different types of de-escalation clinical studies. In particular, because as you saw in the SOUND and INSEMA studies, when we de-escalate one modality of the multimodality therapy, i.e., surgery, the other modalities such as radiation therapy and systemic therapy were “controlled” where we were not de-escalating multiple different modalities. However, as the audience may be familiar with, there are other types of de-escalation studies in particular radiation therapy, partial breast irradiation or omission of radiation therapy, and in those studies, the surgery is now controlled where oftentimes the patients are undergoing surgical axillary staging. And conversely when we're looking at endocrine therapy versus radiation therapy clinical trials, in those studies also the majority of the patients are undergoing surgical axillary staging. And so now as those studies demonstrate the oncologic safety of omission of a particular therapy, we will be in a position of more balancing of the data of trying to select which patients are the safe patients for omission of certain types of modality, and how do we balance whether it's surgery, radiation therapy, systemic therapy, endocrine therapy. And that's where as Dr. Torres stated, the shared decision making will become critically important. I'm a surgeon and so as a surgeon, I get to see the patients oftentimes first, especially when they have early-stage breast cancer. And so I could I guess be “selfish” and just do whatever I think is correct. But whatever the surgeon does, the decision does have consequences in the downstream decision making. And so the field really needs to, as Dr. Torres stated earlier, rethink the workflow of how early-stage breast cancer patients are brought forth and managed as a multidisciplinary team. I also think in future studies the expansion of the data to larger tumors, T3, in particular,reater than 5 cm and also how do we incorporate omission in that population will become more evident as we learn more about the oncologic safety of omitting sentinel lymph node biopsy. Dr. Mylin Torres: In addition, there are other outstanding ongoing clinical trials that are accruing patients right now. They include the BOOG 2013-08 study, SOAPET, NAUTILUS and the VENUS trials, all looking at patients with clinical T1, T2N0 disease and whether omission of sentinel lymph node biopsy is safe with various endpoints including regional recurrence, invasive disease-free survival and distant disease-free survival. I expect in addition to these studies there will be more studies ongoing even looking at the omission of sentinel lymph node biopsy in the post-neoadjuvant chemotherapy setting. And as our imaging improves in the future, there will be more studies improving other imaging modalities, probably in addition to axillary ultrasound in an attempt to accurately characterize whether lymph nodes within axilla contain cancer or not, and in that context whether omission of sentinel lymph node biopsy even in patients with larger tumors post-neoadjuvant chemotherapy may be done safely and could eventually become another shift in our treatment paradigm. Brittany Harvey: Yes. The shared decision making is key as we think about these updates to improve quality of life and we'll await data from these ongoing trials to inform future updates to this guideline. So I want to thank you both so much for your extensive work to update this guideline and thank you for your time today. Dr. Park and Dr. Torres. Dr. Mylin Torres: Thank you. Dr. Ko Un "Clara" Park: Thank you. Brittany Harvey: And thank you to all of our listeners for tuning in to the ASCO Guidelines podcast. To read the full guideline, go to www.asco.org/breast-cancer-guidelines. You can also find many of our guidelines and interactive resources in the free ASCO Guidelines app available in the Apple App Store or the Google Play Store. If you have enjoyed what you've heard today, please rate and review the podcast and be sure to subscribe so you never miss an episode. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.
This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/CC/NCPD/CPE/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/DEJ865. CME/MOC/CC/NCPD/CPE/AAPA/IPCE credit will be available until March 26, 2026.Intelligently Achieving the Potential of Adjuvant CDK4/6 Inhibition in Reducing Risk of Recurrence While Maintaining QOL in HR+, HER2- EBC: An AI-Driven Educational Resource for Improving MDT Collaboration and Patient-Clinician Communication In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an educational grant from Lilly.Disclosure information is available at the beginning of the video presentation.
This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/CC/NCPD/CPE/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/DEJ865. CME/MOC/CC/NCPD/CPE/AAPA/IPCE credit will be available until March 26, 2026.Intelligently Achieving the Potential of Adjuvant CDK4/6 Inhibition in Reducing Risk of Recurrence While Maintaining QOL in HR+, HER2- EBC: An AI-Driven Educational Resource for Improving MDT Collaboration and Patient-Clinician Communication In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an educational grant from Lilly.Disclosure information is available at the beginning of the video presentation.
This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/CC/NCPD/CPE/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/DEJ865. CME/MOC/CC/NCPD/CPE/AAPA/IPCE credit will be available until March 26, 2026.Intelligently Achieving the Potential of Adjuvant CDK4/6 Inhibition in Reducing Risk of Recurrence While Maintaining QOL in HR+, HER2- EBC: An AI-Driven Educational Resource for Improving MDT Collaboration and Patient-Clinician Communication In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an educational grant from Lilly.Disclosure information is available at the beginning of the video presentation.
This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/CC/NCPD/CPE/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/DEJ865. CME/MOC/CC/NCPD/CPE/AAPA/IPCE credit will be available until March 26, 2026.Intelligently Achieving the Potential of Adjuvant CDK4/6 Inhibition in Reducing Risk of Recurrence While Maintaining QOL in HR+, HER2- EBC: An AI-Driven Educational Resource for Improving MDT Collaboration and Patient-Clinician Communication In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an educational grant from Lilly.Disclosure information is available at the beginning of the video presentation.
Featuring an interview with Dr Sara A Hurvitz, including the following topics: Role of endocrine therapy in the management of HER2-positive breast cancer; implications of the Phase III PATINA study (0:00) Case: A woman in her mid 60s with node-negative, HR-positive, HER2-negative localized breast cancer and a Recurrence Score® of 28 (8:38) Available data guiding the selection of an adjuvant CDK4/6 inhibitor (12:49) Selection of a CDK4/6 inhibitor in the metastatic setting (23:16) Available therapies for patients with HR-positive metastatic breast cancer (mBC) and PIK3CA mutations; implications of the Phase III INAVO120 study (29:17) Case: A woman in her early 60s with HR-positive, HER2-negative mBC with short duration of benefit from a first-line CDK4/6 inhibitor and an aromatase inhibitor (AI) and coexisting PIK3CA and ESR1 mutations (37:11) Available data with approved and investigational oral SERDs (selective estrogen receptor degraders) (43:23) Case: A woman in her early 70s with HR-positive, HER2-negative mBC and an ESR1 mutation detected on disease progression after durable responses to first-line endocrine therapy and second-line CDK4/6 inhibitor with an AI (51:38) Selection of therapy for patients with HR-positive mBC and coexisting targetable genetic mutations (53:11) Case: A woman in her late 50s with HR-positive, HER2-negative mBC and an ESR1 mutation detected on disease progression after first-line CDK4/6 inhibitor with an AI (1:00:17) CME information and select publications
Featuring an interview with Dr Komal Jhaveri, including the following topics: Emerging treatment options for advanced ER-positive breast cancer (0:00) Burstein H. Emerging treatment options for advanced ER+ breast cancer. San Antonio Breast Cancer Symposium 2024;Abstract GS1-01 Discussant. Elacestrant real-world progression-free survival for adult patients with ER-positive, HER2-negative advanced breast cancer: A retrospective analysis using insurance claims in the United States (7:28) Swallow E et al. Elacestrant real-world progression-free survival (rwPFS) of adult patients with ER+/HER2-, advanced breast cancer: A retrospective analysis using insurance claims in the United States. San Antonio Breast Cancer Symposium 2024;Abstract P3-10-08. Ongoing clinical trials involving oral SERDs (9:03) Kaklamani V et al. ELCIN: Elacestrant in women and men with CDK4/6 inhibitor (CDK4/6i)-naïve estrogen receptor-positive (ER+), HER2-negative (HER2-) metastatic breast cancer (mBC): An open-label multicenter phase 2 study. San Antonio Breast Cancer Symposium 2024;Abstract P2-08-20. An adjuvant endocrine-based therapy study of camizestrant (AZD9833) in ER+/HER2- early breast cancer (CAMBRIA-2). NCT05952557 Bardia A et al. ELEGANT: Elacestrant versus standard endocrine therapy in women & men with node-positive, estrogen receptor-positive, HER2-negative, early breast cancer with high risk of recurrence in a global, multicenter, randomized, open-label phase 3 study. San Antonio Breast Cancer Symposium 2024;Abstract P2-08-21. Precision therapeutics and emerging strategies for HR-positive metastatic breast cancer (13:48) Lloyd MR et al. Precision therapeutics and emerging strategies for HR-positive metastatic breast cancer. Nat Rev Clin Oncol 2024;21(10):743-61. Abstract CME information and select publications
Molecular differences in the profiles of low grade serous ovarian cancer (LGSOC) and high-grade SOC substantiate the need to find unique, differentiated treatment options for each epithelial ovarian cancer subtype, according to Kathleen N. Moore, MD, MS. CancerNetwork® spoke with Moore, Virginia Kerley Cade Endowed Chair of Cancer Development, associate director of Clinical Research at the Stephenson Cancer Center, director of the Oklahoma TSET Phase I Program and professor in the Section of Gynecologic Oncology the University of Oklahoma Health Sciences Center, about distinguishing low grade serous ovarian cancer from other types of ovarian cancer, current treatment options and clinical trials evaluating new regimens, as well as managing treatment in younger patients with or those seeking to preserve fertility. Moore began by differentiating LGSOC from high grade SOC, stating that this disease typically occurred in younger patients and was primarily characterized by MAP kinase alterations, specifically KRAS and BRAF mutations. She then discussed the emergence of endocrine therapies in this indication owing to the presence of estrogen receptors. Additionally, first line treatment was discussed, with the standard of care defined by primary cytoreduction followed by paclitaxel and carboplatin. She then highlighted multiple clinical trials assessing alternative treatment in this indication, particularly involving the use of letrozole (Femara). Other clinical trials evaluated the use of CDK4/6 inhibition plus fulvestrant or BRAF and MEK inhibition with letrozole, with Moore emphasizing the potential for these studies to shift the treatment paradigm in the frontline setting. Furthermore, she suggested that CDK4/6 inhibition may help enhance responses in patients with recurrent LGSOC. Moore then highlighted treatment concerns for younger patients and those seeking to preserve fertility, while expressing the importance of understanding a patient's goals, which may help optimize outcomes. She concluded by reiterating the importance of designing trials and tailoring treatment considering the molecular profile of LGSOC.
Oncology Here & NowIn this interview, Dr. Elisa Agostinetto from the Jules Bordet Institute in Belgium speaks with Dr. Maryam Lustberg from Yale Cancer Center. Together, they dive deep into the use of CDK 4/6 inhibitors in the adjuvant treatment of breast cancer. Their discussion covers the use of Abemaciclib and Ribociclib following the monarchE and NATALEE trials, applications in the treatment of male breast cancer, and much more.Join us!
En este primer episodio de BreastLink, el Dr. Juan Carlos Samamé, oncólogo médico, Vicepresidente de LABCA en Lima, Perú, da la bienvenida a la Dra. Eva Ciruelos, una destacada especialista en cáncer de mama y Vicepresidenta del grupo SOLTI en Madrid, España. En esta dinámica, se centraron en el estudio PATINA, un ensayo fase III que explora el uso de palbociclib como tratamiento de mantenimiento en pacientes con cáncer de mama avanzado RH+/HER2-positivo. A lo largo del podcast, la Dra. Ciruelos detalla los objetivos del estudio, su población, y cómo este tratamiento busca mejorar la supervivencia libre de progresión (SLP), sin sustituir terapias existentes, sino complementándolas.Durante la conversación, la Dra. Ciruelos explica los resultados del estudio PATINA, destacando una mejora significativa en la SLP en el grupo que recibió palbociclib, con una mediana de 44.3 meses frente a los 29.1 meses del grupo de control. Además, se habló sobre antecedentes de otros estudios como monarcHER y PATRICIA, que también analizaron inhibidores de CDK4/6 en contextos similares. También se discutió la relevancia de estos tratamientos en el contexto de la enfermedad metastásica y cómo la combinación de terapias dirigidas al ciclo celular, bloqueo de HER2 y estrógeno, puede ser una opción importante para prolongar la respuesta sin recurrir a tratamientos más agresivos como la quimioterapia. Finalmente, se abordó el futuro de las terapias de mantenimiento y la necesidad de desescalar tratamientos a largo plazo en pacientes que han mostrado respuesta prolongada, así como la integración de nuevos inhibidores de PI3K.Dentro de su conversación, se plantearon las siguientes preguntas:¿Cómo el estudio PATINA busca mejorar la SLP en pacientes con cáncer de mama avanzado RH-positivo?¿Cuál fue el impacto de palbociclib en la SLP en comparación con el grupo control?¿Cómo se relacionan los resultados del estudio PATINA con otros estudios previos como monarcHER o PATRICIA?¿Cuál es el enfoque clínico actual en cuanto a la desescalada de tratamientos a largo plazo en pacientes con cáncer de mama avanzado?¿Qué nuevas terapias y combinaciones se perfilan a futuro, como los inhibidores de PI3K, y cómo podrían cambiar el manejo de estos pacientes?Fecha de grabación: 12 de febrero de 2025. Todos los comentarios emitidos por los participantes son a título personal y no reflejan la opinión de ScienceLink u otros. Se deberá revisar las indicaciones aprobadas en el país para cada uno de los tratamientos y medicamentos comentados. Las opiniones vertidas en este programa son responsabilidad de los participantes o entrevistados, ScienceLink las ha incluido con fines educativos. Este material está dirigido a profesionales de la salud exclusivamente.
Featuring an interview with Dr Komal Jhaveri, including the following topics: Imlunestrant, an oral selective estrogen receptor degrader (SERD), with and without abemaciclib for ER-positive, HER2-negative advanced or metastatic breast cancer (0:00) Jhaveri KL et al. Imlunestrant, an oral selective estrogen receptor degrader (SERD), as monotherapy & combined with abemaciclib, for patients with ER+, HER2- advanced breast cancer (ABC), pretreated with endocrine therapy (ET): Results of the phase 3 EMBER-3 trial. San Antonio Breast Cancer Symposium 2024;Abstract GS1-01. Jhaveri KL et al. Imlunestrant with or without abemaciclib in advanced breast cancer. N Engl J Med 2024;[Online ahead of print]. Abstract Rugo HS et al. Elacestrant abemaciclib (abema) combination in patients (pts) with estrogen receptor-positive (ER+), HER2-negative (HER2-) advanced or metastatic breast cancer (mBC). San Antonio Breast Cancer Symposium 2024; Abstract PS7-07. Elacestrant for ER-positive, HER2-negative metastatic breast cancer with ESR1-mutated tumors: Subgroup analyses from the Phase III EMERALD trial by duration of prior endocrine therapy with a CDK4/6 inhibitor and in clinical subgroups (7:40) Bardia A et al. Elacestrant in ER+, HER2- MBC with ESR1-mutated tumors: Subgroup analyses from the phase III EMERALD trial by prior duration of endocrine therapy plus CDK4/6 inhibitor and in clinical subgroups. Clin Cancer Res 2024;30(19):4299-309. Abstract Pharmacokinetics and safety of imlunestrant in patients with hepatic impairment (11:25) Wang XA et al. Evaluation of pharmacokinetics and safety of imlunestrant in participants with hepatic impairment. San Antonio Breast Cancer Symposium 2024;Abstract P4-10-07. Precision therapeutics and emerging strategies for HR-positive metastatic breast cancer (13:15) Lloyd MR et al. Precision therapeutics and emerging strategies for HR-positive metastatic breast cancer. Nat Rev Clin Oncol 2024;21(10):743-61. Abstract CME information and select publications
Welcome to the Oncology Brothers podcast! In this episode, Drs. Rahul and Rohit Gosain are joined by Dr. Kevin Kalinsky, a leading breast medical oncologist and director of the breast cancer program at the Winship Cancer Institute of Emory University. Join us as we dive deep into the complexities of hormone receptor-positive breast cancer treatment. We discuss the latest advancements in treatment algorithms, including the use of OncotypeDX in premenopausal versus postmenopausal women, the role of ovarian function suppression, and the implications of new approvals like Inavolisib and CDK4-6 inhibitors. Key topics covered in this episode: • The significance of recurrence scores in dictating adjuvant chemotherapy • The ongoing OFSET trial and its potential impact on treatment decisions • Insights into the use of genomic assays like MammaPrint and RS-Clin • The evolving landscape of treatment options for locally advanced and metastatic breast cancer • The latest on PARP inhibitors, T-DXd, and other novel therapies Whether you're a medical professional or someone interested in the latest in oncology, this episode is packed with valuable insights and clinical pearls. Don't forget to subscribe for more discussions on cancer treatment, FDA approvals, and conference highlights! YouTube: https://youtu.be/_icBN3J3Bc0 Follow us on social media: • X/Twitter: https://twitter.com/oncbrothers • Instagram: https://www.instagram.com/oncbrothers #OncologyBrothers #HR+ #breastcancer #HormoneReceptorPositiveCancer #oncbrothers #Podcast
In this episode, Jame Abraham, MD, FACP; William J. Gradishar, MD, FACP, FASCO; and Laura Spring, MD, review key insights and frequently asked questions related to the CDK4/6 inhibitors used to treat patients with early and metastatic hormone receptor (HR)–positive/HER2-negative breast cancer from a live program held in January 2025. Key clinical pearls include:Adjuvant treatment selection recommendations for patients with HR-positive/HER2-negative early breast cancer based on disease and patient characteristics as well as the latest data and guidelines presented by Dr. GradisharTherapeutic strategies for patients diagnosed with HR-positive/HER2-negative metastatic breast cancer (MBC) presented by Dr. AbrahamAddressing challenges related to CDK4/6 inhibitor adherence and adverse event mitigation presented by Dr. SpringPresenters:Jame Abraham, MD, FACPEnterprise Chair and Professor of MedicineDepartment of Hematology and Medical OncologyCleveland ClinicCleveland, OhioWilliam J. Gradishar, MD, FACP, FASCOBetsy Bramsen Professor of Breast OncologyRobert H. Lurie Comprehensive Cancer CenterNorthwestern UniversityChicago, IllinoisLaura Spring, MDBreast Medical OncologistMass General Hospital Cancer CenterHarvard Medical SchoolBoston, MassachusettsLink to full program including downloadable slides and on-demand webcasts: https://bit.ly/4b5GFqqTo claim credit for listening to this episode, please visit the podcast online at the link above.
Featuring slide presentations and related discussion from Dr Joyce O'Shaughnessy, Dr Mark Pegram and Prof Peter Schmid, including the following topics: Strategies to Identify Patients with HER2-Low and HER2-Ultralow Breast Cancer (0:00) Case: A woman in her mid 50s initially presenting with ER-positive, HER2 IHC 1+ locally advanced breast cancer who experiences progression to HER2 0 metastatic disease (20:53) Case: A woman in her early 60s with ER-positive, HER2 IHC 1+ metastatic breast cancer (mBC) who experiences disease progression 8 months after starting first-line CDK4/6 and aromatase inhibitor (29:14) Expanding the Spectrum of Targeted Therapy (38:52) Case: A woman in her early 60s with HR-positive, HER2 IHC 1+ mBC who receives fifth-line T-DXd resulting in stable disease (1:04:13) Case: A woman in her early 50s with progressive HR-positive, HER2 IHC 0 mBC and an ESR1 mutation who has ultralow HER2 expression on rebiopsy of new liver lesions (1:12:35) Identification and Management of Adverse Events with T-DXd (1:20:27) Case: A woman in her late 40s with HR-positive, HER2 IHC 2+ mBC who experienced persistent low-grade nausea with T-DXd that resolved with olanzapine (1:34:02) Case: A woman in her early 60s with ER-positive, HER2 2+ mBC who received T-DXd resulting in fatigue and asymptomatic interstitial lung disease (1:48:58) CME information and select publications
Featuring an interview with Dr Seth Wander, including the following topics: Therapy selection after CDK4/6 inhibitor failure: A review of current and investigational treatment for HR-positive, HER2-negative breast cancer Astore S et al. A therapeutic algorithm guiding subsequent therapy selection after CDK4/6 inhibitors' failure: A review of current and investigational treatment for HR+/Her2- breast cancer. Crit Rev Oncol Hematol 2024;204:104535. Abstract (0:00) A preoperative window-of-opportunity study of the oral SERD imlunestrant for newly diagnosed ER-positive, HER2-negative localized breast cancer Neven P et al. A preoperative window-of-opportunity study of oral SERD, imlunestrant, in newly diagnosed ER-positive, HER2-negative early breast cancer: Results from the EMBER-2 Study. Clin Cancer Res 2024;30(23):5304-13. Abstract (3:30) An assessment of an exosome-based ESR1-monitoring RT-qPCR kit that detects acquired resistance variants in liquid biopsy samples Statt S et al. An exosome-based ESR1 monitoring RT-qPCR kit that rapidly and accurately detects acquired resistance variants at ≤ 0.1% frequency in liquid biopsy samples. ESMO 2024;Abstract 420P. (7:08) CME information and select publications
In this episode of Onc Now, Jonathan is joined by Dr Dave Cescon, a Medical Oncologist and Clinician Scientist at the Princess Margaret Cancer Centre, Toronto, Canada. Together, they explore the transformative impact of CDK4/6 inhibitors, challenges in liquid biopsy research, and the potential of mRNA vaccines in oncology. Timestamps: (02:44) -Swimming in Toronto: Competitive vs. Open Water (08:06) -From Internal Medicine to Breast Cancer Research (14:09) -Translational research and circulating tumour DNA (19:53) -The role of CDK4/6 inhibitors in breast cancer (29:04) -FDA approval of ribociclib for high-risk early breast cancer (31:45) -The future of mRNA vaccines for personalised cancer care (37:34) -Dave's research challenges and innovations (39:13) -Three wishes for healthcare
Dr. Jasmine Sukumar and Dr. Dionisia Quiroga discuss advances in adjuvant therapy for patients with early breast cancer and BRCA1/2 mutations, including how to identify patients who should receive genetic testing and the significant survival benefits of olaparib that emerged from the OlympiA trial. TRANSCRIPT Dr. Jasmine Sukumar: Hello, I'm Dr. Jasmine Sukumar, your guest host of the ASCO Daily News Podcast today. I'm an assistant professor and breast medical oncologist at the University of Texas MD Anderson Cancer Center. On today's episode, we'll be exploring advances in adjuvant therapy for high-risk early breast cancer in people with BRCA1/2 germline mutations. Joining me for this discussion is Dr. Dionisa Quiroga, an assistant professor and breast medical oncologist at the Ohio State University Comprehensive Cancer Center. Our full disclosures are available in the transcript of this episode. Dr. Quiroga, it's great to have you on the podcast. Thanks for being here. Dr. Dionisia Quiroga: Thank you. Looking forward to discussing this important topic. Dr. Jasmine Sukumar: Let's start by going over who should be tested for BRCA1/2 genetic mutations. How do you identify patients with breast cancer in your clinic who should be offered BRCA1/2 genetic testing? Dr. Dionisia Quiroga: So, guidelines on who to offer testing to somewhat differ between organizations at this point. I would say, generally, I do follow our current ASCO-Society of Surgical Oncology (SSO) Guidelines, though. Those guidelines recommend that BRCA1/2 mutation testing be offered to all patients who are diagnosed with breast cancer and are 65 years old or younger. For those that are older than 65 years old, there are additional factors to really take into account to decide on who to recommend testing for. Some of this has to do with personal and family history as well as ancestry. The NCCN also has their own specific guidelines for who to offer testing to. For example, people assigned male at birth; those who are found to have a second breast primary; those who are diagnosed at a young age; and those with significant family history should also be offered BRCA1/2 testing. I think, very important for our discussion today, ASCO and SSO also made a very important point that all patients who may be eligible for PARP inhibitor therapy should be offered testing. So clearly this includes a large amount of our patient population. In my practice, we often refer to our Cancer Genetics Program. We're fortunate to have many experienced genetic counselors who can complete pre-test and post-test counseling with our patients. However, in settings where this may not be accessible to patients, it can also be appropriate for oncology providers to order the testing and ideally perform some of this counseling as well. Dr. Jasmine Sukumar: Thank you Dr. Quiroga. Let's next review where we are in current clinical practice guidelines. What current options do we have for adjuvant therapy specific to people with high-risk early breast cancer and BRCA1/2 genetic mutations? Dr. Dionisia Quiroga: Our current guidelines recommend adjuvant olaparib for one year for individuals with HER2-negative high risk breast cancer. This approval largely came from the data and the results of the OlympiA trial. This was a prospective phase 3, double blind, randomized clinical trial. It enrolled patients who had been diagnosed with HER2-negative early-stage breast cancer who also carried germline pathogenic or likely pathogenic variants of either the BRCA1 and/or BRCA2 genes. The disease also had to be considered high-risk and there were several criteria that had to be evaluated to deem whether or not these patients were high-risk. For example, those who are treated with neoadjuvant chemotherapy, if they had disease that was triple-negative, they needed to have some level of invasive residual disease at time of surgery. Alternatively, if the disease was hormone receptor-positive, they needed to have residual disease and a calculated CPS + EG score of 3 or higher. This scoring system is something that estimates relapse probability on the basis of clinical and pathologic stage, ER status, and histologic grade, and this will give you a score ranging from 0 to 6. In general, the higher the score, the worse the prognosis. This calculator though is available to the public online to allow providers to calculate this risk. For the subset of patients who received adjuvant chemotherapy, for them to qualify for the OlympiA trial, if they had triple-negative disease, they needed to have a tumor of at least 2 cm or greater and/or have positive lymph nodes for disease. For hormone receptor-positive disease that was treated with adjuvant chemotherapy, they were required to have four or more pathologically confirmed positive lymph nodes at time of surgery. From this specified pool, patients were then randomized 1:1 to get either adjuvant olaparib starting at 300 mg twice a day or a matching placebo twice a day after they had completed surgery, chemotherapy and radiation treatment if needed. Dr. Jasmine Sukumar: And what were the outcomes of this study? Dr. Dionisia Quiroga: The study ended up enrolling over 1,800 patients and from these 1,800 patients, 70% had a BRCA1 mutation while 30% had a BRCA2 mutation. About 80% of the patients had triple-negative disease compared to hormone receptor-positive disease. Interestingly, about half of all patients enrolled had received neoadjuvant chemotherapy while the other half received adjuvant chemotherapy. Looking at the outcomes, this was overall a very positive study. We actually now have outcomes data from a median of about 6 years out. This was just reported in December at the 2024 San Antonio Breast Cancer Symposium. There was found to be a 9.4% absolute difference in six-year invasive disease-free survival favoring the olaparib arm over the placebo arm. What was also interesting is that this was consistent across multiple subgroups of patients and the benefit was really seen whether or not they had hormone receptor-positive or triple-negative disease. The absolute difference in distant disease-free survival was also high at 7.8% and additionally favored olaparib. Most importantly, there was found to be a significant overall survival benefit. The six-year overall survival was 87.5% in the olaparib group compared to 83.2% in the placebo group. This translates to about a 4.4% difference and a relative 28% overall survival benefit in using olaparib. Now, future follow up is going to be very important. Follow up for this study is actually planned to continue out until June 2029 so we can continue to observe if these survival curves will continue to branch apart as they have so far at each follow up. And I think this is especially important for those patients diagnosed with hormone receptor-positive cancers because we know those patients are at particular risk for later recurrences. As an additional side note, the researchers also noted that there were fewer primary malignancies in the olaparib group, not just of the breast but also primary ovarian or fallopian tube cancers as well, which is not completely surprising knowing that this drug is also heavily used and beneficial in different types of gynecologic cancers. Ultimately, the amount of adverse events reported have been low with only about 9.9% of patients receiving olaparib needing to discontinue drug due to adverse events, and this is compared to 4.2% reported in the placebo group. Dr. Jasmine Sukumar: You mentioned that the OlympiA trial showed an overall survival benefit, but interestingly the OlympiAD trial looking at olaparib versus chemotherapy in patients with advanced metastatic HER2-negative breast cancer did not show a significant overall survival benefit. Could you discuss those differences? Dr. Dionisia Quiroga: I agree, that's a very good point. So OlympiA's comparator arm was, of course, a placebo. So while this isn't the same as comparing to chemotherapy, it does still potentially suggest that there is a degree of benefit that olaparib can provide when it's introduced in the early local disease setting compared to advanced metastatic disease. I think we need more future trials looking at potential other combinations to see if we can improve the efficacy of PARP inhibitors in the metastatic setting. Dr. Jasmine Sukumar: For patients who do choose to proceed with use of adjuvant olaparib due to the promising efficacy, what side effects should oncologists counsel their patients about? Dr. Dionisia Quiroga: The most common notable side effects, I would say with olaparib and other PARP inhibitors are really cytopenias. Gastrointestinal side effects such as nausea and vomiting can occur as well as fatigue. There are some less common but potentially more serious side effects that we should counsel our patients on. This includes pneumonitis. So counseling patients on if they're short of breath or experiencing cough to let their provider know. Venous thromboembolism can also be increased rates of occurrence. And then of course myelodysplastic syndromes or acute myeloid leukemia is something that we often are concerned about. That being said, I think it should be noted that interestingly in the OlympiA trial so far, there have been less new cases of MDS and AML in the olaparib group than actually what's been reported in the placebo group at this median follow up of over six years out. So we'll need to continue to monitor this endpoint over time, but I do think this provides some reassurance. Dr. Jasmine Sukumar: Since the initiation of the OlympiA trial, other adjuvant treatments have also been studied and FDA approved for non-metastatic HER2-negative breast cancer. So for example, the CREATE-X trial established adjuvant capecitabine as an FDA approved treatment option in patients with triple-negative breast cancer who had residual disease following neoadjuvant chemotherapy. So if a patient with triple-negative breast cancer with residual disease is eligible for both adjuvant olaparib and adjuvant capecitabine treatments, how do you decide amongst the two? Dr. Dionisia Quiroga: If a patient's eligible for both, I honestly often favor olaparib, and I do this because I find the data for adjuvant olaparib a little bit more compelling. There are also differences in toxicity profile and treatment duration between the two that I think we should discuss with patients. For example, olaparib is supposed to be taken for a year total, whereas with capecitabine we typically treat for six to eight cycles with each cycle taking three weeks. There are some who may also sequence the two drugs in very high-risk disease. However, this is very much a data free zone. We don't have any current clinical trials really comparing these two or if sequencing of these agents is appropriate. So I don't currently do this in my own clinical practice. Dr. Jasmine Sukumar: Nowadays, almost all patients with stage 2 to 3 triple-negative breast cancer will be offered neoadjuvant chemotherapy plus immune checkpoint inhibitor therapy pembrolizumab per our KEYNOTE-522 trial data. With our current approach, pembrolizumab is continued into the adjuvant setting regardless of surgical outcome, so that patients receive a year total of immunotherapy. So in patients with residual disease and a BRCA germline mutation, do you suggest using adjuvant olaparib concurrently with pembrolizumab? Do we have any data to support that approach? Dr. Dionisia Quiroga: I do. I do use them concurrently. If a patient is eligible for adjuvant olaparib, I would use it the same way as if they were not on pembrolizumab. That being said, there are no large studies currently that have shown what the benefit or the toxicity of pembrolizumab plus olaparib are for early-stage disease. However, we do have some safety data of this combinatorial approach from other studies. For example, the phase 2/3 KEYLYNK-009 study showed that patients with advanced metastatic triple-negative breast cancer who were receiving concurrent pembrolizumab and olaparib had a manageable safety profile, particularly as the toxicities of these drugs alone don't tend to overlap. Dr. Jasmine Sukumar: And what about endocrine therapy for those that also have hormone receptor-positive disease? Dr. Dionisia Quiroga: Adjuvant endocrine therapy should definitely be continued while patients are on olaparib if they're hormone receptor-positive. An important component of this will also likely be ovarian suppression, which should include recommendation of risk reducing bilateral salpingo oophorectomy due to the risk of ovarian cancer development in patients who carry BRCA1/2 gene mutations. In most cases, this should happen at age 40 or before for those that carry a BRCA1 mutation, and at age 45 or prior for those with BRCA2 mutations. Dr. Jasmine Sukumar: And do you also consider adjuvant bisphosphonates in this context? Dr. Dionisia Quiroga: Yes. Like adjuvant endocrine therapy, adjuvant bisphosphonates were also instructed to be given according to standard guidelines in the OlympiA trial, so I would recommend use of bisphosphonates when indicated. You can refer to the ASCO Ontario Health Guidelines on Adjuvant Bone-Modifying Therapy Breast Cancer to guide that decision in order to utilize this due to multiple clinical benefits. It doesn't just help in terms of adjuvant breast cancer treatment but also reduction of fracture rate and down the line, improved breast cancer mortality. Dr. Jasmine Sukumar: Particularly in hormone receptor-positive breast cancer, another adjuvant therapy option that was not available when the OlympiA trial started are the CDK4/6 inhibitors, ribociclib and abemaciclib, based on the NATALEE and monarchE studies. So how do you consider the use of these adjuvant therapy drugs in the context of olaparib and BRCA mutations? Dr. Dionisia Quiroga: Yeah, so we are definitely in a data-free zone here. And that's in part because the NATALEE and the monarchE studies are still ongoing and reporting data out at the same time that we're getting updated OlympiA data. So unlike some of our other adjuvant treatments that we discussed, where olaparib could be safely given concurrently, the risk of myelosuppression and using both a CDK4/6 inhibitor and a PARP inhibitor at the same time would be too high. In some cases, even if a patient has a BRCA1/2 mutation, they may not meet that specified inclusion criteria that OlympiA set for what they consider to be high-risk disease. And we know from the NATALEE and the monarchE trial there are also different markers that they use to denote high-risk disease. So it's possible, for example, in the NATALEE trial that looks specifically at adjuvant ribociclib, they included a much larger pool of hormone receptor-positive early-stage breast cancers, including a subset that did not have positive axillary lymph nodes. In cases where patients would qualify for both olaparib and a CDK4/6 inhibitor, I think this is worth a nuanced discussion with our patients about the potential benefits, risks and administration of these drugs. I think another point to bring up is the cost associated with these drugs and the length of time patients will be on for, because financial toxicity is always something that we should bring up with patients as well. When sequencing these in high-risk disease, my practice is to generally favor olaparib first due to the overall survival data. There is also some data to support that patients with BRCA1/2 germline mutations may not respond quite as well to CDK4/6 inhibitors compared to those without. But again, this is still outside of the purview of current guidelines. Fortunately, we have more potential choices for patients, and that's a good thing, but shared decision making also needs to be key. Dr. Jasmine Sukumar: And while our focus today is on adjuvant treatment for people who carry germline BRCA mutations, what about other related gene mutations such as PALB2 pathogenic variant? Dr. Dionisia Quiroga: That's a great question. Clinical trials in the advanced metastatic setting have shown that there is efficacy of olaparib in the setting for PALB2 mutations. This is largely based on the TBCRC 048 phase 2 trial and that provided a Category 2B NCCN recommendation for patients with these PALB2 gene mutations. However, we're really still lacking enough clinical data for use in early-stage disease, so I don't currently use adjuvant olaparib in this case. I am definitely eager for more data in this area as the efficacy of PARP inhibitors in PALB2 gene mutations is very compelling. I think also, in the same line, there's been some data for somatic BRCA1/2 mutations in the metastatic setting, but we still have a lack of data for the early stage setting here as well. Dr. Jasmine Sukumar: Thank you Dr. Quiroga, for sharing your valuable insights with us today on the ASCO Daily News Podcast. Dr. Dionisia Quiroga: Thank you, Dr. Sukumar. Dr. Jasmine Sukumar: And thank you to our listeners for your time today. You'll find links to the studies discussed today in the transcript of this episode. Finally, if you value the insights that you hear on the ASCO Daily News Podcast, please take a moment to rate, review and subscribe wherever you get your podcasts. Thank you. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Follow today's speakers: Dr. Dionisa Quiroga @quirogad @quirogad.bsky.social Dr. Jasmine Sukumar @JasmineSukumar @jasmine.sukumar.bsky.social Follow ASCO on social media: @ASCO on X @ASCO on Bluesky ASCO on Facebook ASCO on LinkedIn Disclosures: Dr. Dionisia Quiroga: No relationships to disclose Dr. Jasmine Sukumar: Honoraria: Sanofi (Immediate Family Member)
Join us for another insightful episode of the Oncology Brothers podcast as we dive into the latest breakthroughs in breast cancer research from the San Antonio Breast Cancer Symposium 2024. In this episode, hosts Drs. Rahul and Rohit Gosain are joined by Dr. Sara Tolaney from Dana-Farber Cancer Institute to discuss three pivotal studies: 1. DESTINY-Breast06 - An update on the efficacy of T-DXd in HER2 low and ultra-low breast cancer patients, highlighting its potential to change treatment paradigms for endocrine refractory disease. 2. DESTINY-Breast12 - Exploring the robust intracranial activity of T-DXd in patients with brain metastases and its impact on quality of life. 3. PATINA Trial - A groundbreaking study on the use of CDK4-6 inhibitors in combination with trastuzumab and pertuzumab for ER-positive, HER2-positive breast cancer, showcasing impressive progression-free survival rates. Tune in as we unpack the implications of these studies for clinical practice and discuss the future of breast cancer treatment. Don't forget to like, subscribe, and hit the notification bell for more updates on oncology research and treatment strategies! Follow us on social media: • X/Twitter: https://twitter.com/oncbrothers • Instagram: https://www.instagram.com/oncbrothers For more information, visit our website: OncologyBrothers.com #OncologyBrothers #BreastCancer #SABCS2024 #TDXD #PATINA #CancerResearch #Podcast
Welcome to another episode of the Oncology Brothers podcast! In this episode, hosts Rahul and Rohit Gosain are joined by Dr. Jame Abraham from the Cleveland Clinic to discuss key abstracts in the hormone receptor-positive breast cancer space from the San Antonio Breast Cancer Symposium 2024. Episode Highlights: • EUROPA Trial: A phase 3 study comparing endocrine therapy versus radiation therapy in early-stage breast cancer patients over 70. Discover how the results may impact clinical practice and patient decision-making. • TAILORx Study: Updates on the benefits of anthracycline-based chemotherapy for patients with a recurrence score of 31 and above. Learn how this data influences treatment options for younger patients. • PADMA Study: Insights into the role of CDK4/6 inhibitors combined with endocrine therapy versus chemotherapy in aggressive disease settings. Understand why this combination remains the standard of care. • EMBER-3 Study: An exploration of the new oral selective estrogen receptor degrader, imlunestrant, and its promising results in combination with abemaciclib for patients with hormone receptor-positive, HER2-negative metastatic breast cancer. Join us as we delve into these important studies and their implications for the future of breast cancer treatment. Don't forget to check out our other conference highlights from ASH 2024 and SABCS 2024! Subscribe for more insights and updates in oncology! Website: http://www.oncbrothers.com/ X/Twitter: https://twitter.com/oncbrothers Contact us at info@oncbrothers.com
Following the 2024 San Antonio Breast Cancer Symposium (SABCS), Paolo Tarantino, MD, and Matteo Lambertini, MD, PhD, co-hosted a live X Space with CancerNetwork® and spoke about updated trial findings that may impact the breast cancer treatment paradigm. Tarantino is a clinical research fellow at Dana-Farber Cancer Institute and Harvard Medical School. Lambertini is an associate professor and consultant in medical oncology at the University of Genova – IRCCS Policlinico San Martino Hospital in Genova, Italy. Tarantino and Lambertini highlighted data from various studies that investigators presented at the Symposium, which included results on the use of treatment modalities such as antibody drug conjugates and CDK4/6 inhibitors. Some presentations of interest included the following: · Phase 3 DESTINY-Breast06 Trial (NCT04494425) o Patients with hormone receptor (HR)–positive, HER2-low or HER2-ultralow metastatic breast cancer were assigned to receive fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) or physician's choice of therapy. o Treatment with T-DXd improved progression-free survival (PFS) among patients with a time to progression on frontline endocrine therapy of less than 6 months (HR, 0.38; 95% CI, 0.25-0.59), 6 to 12 months (HR, 0.69; 95% CI, 0.43-1.12), and more than 12 months (HR, 0.67; 95% CI, 0.51-0.88). o PFS improved with T-DXd regardless of disease burden. · Phase 3 EMBER-3 Trial (NCT04975308) o Investigators evaluated 3 treatment arms—imlunestrant (LY3484356) monotherapy, fulvestrant (Faslodex) or exemestane (Aromasin), and imlunestrant in combination with abemaciclib (Verzenio)—among patients with estrogen receptor (ER)–positive, HER2-negative advanced breast cancer. o Across the overall population, imlunestrant monotherapy improved PFS compared with standard endocrine therapy (HR, 0.87; 95% CI, 0.72-1.04; P = .12). o Imlunestrant plus abemaciclib also showed a PFS improvement vs endocrine therapy across the overall population (HR, 0.57; 95% CI, 0.44-0.73; P
Featuring perspectives from Dr Matthew P Goetz, Dr Sara A Hurvitz, Dr Komal Jhaveri, Dr Virginia Kaklamani and Dr Seth Wander, including the following topics: Introduction (0:00) Role of CDK4/6 Inhibitors in Hormone Receptor (HR)-Positive Localized Breast Cancer — Dr Hurvitz (12:21) Incorporation of CDK4/6 Inhibitors into the Management of HR-Positive, HER2-Negative Metastatic Breast Cancer (mBC) — Dr Wander (34:36) Evolving Role of PI3K Inhibitors for HR-Positive mBC Harboring PIK3CA Mutations — Dr Goetz (57:58) Clinical Utility of AKT Inhibitors for Patients with Progressive HR-Positive mBC — Dr Jhaveri (1:15:52) Oral SERDs (Selective Estrogen Receptor Degraders) for HR-Positive mBC — Dr Kaklamani (1:37:24) CME information and select publications
In this JCO Article Insights episode, Giselle de Souza Carvalho provides a summary on "Navigating Treatment Pathways in Metastatic Hormone Receptor–Positive, HER2-Negative Breast Cancer: Optimizing Second-Line Endocrine and Targeted Therapies" by Bhardwarj, et al and "US Food and Drug Administration Approval Summary: Capivasertib With Fulvestrant for Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Locally Advanced or Metastatic Breast Cancer With PIK3CA/AKT1/PTEN Alterations" by Dilawari et al published in the Journal of Clinical Oncology. TRANSCRIPT Giselle Carvalho: Hello and welcome to JCO Article Insights episode for the December issue of the Journal of Clinical Oncology. I'm your host Giselle Carvalho, Medical Oncologist in Brazil focusing on breast cancer and melanoma skin cancers and one of the ASCO Editorial Fellows at JCO this year. Today, I will be discussing two articles. The first one is “Navigating Treatment Pathways in Metastatic Hormone Receptor–Positive, HER2-Negative Breast Cancer: Optimizing Second-Line Endocrine and Targeted Therapies,” and the second one is the “US FDA Approval Summary on Capivasertib with Fulvestrant for HR-positive HER2-negative Locally Advanced or Metastatic Breast Cancer with PIK3CA/AKT1/PTEN Alteration.” As we know, 65% to 70% of all breast cancers are HR-positive HER2-negative and this is also the most common subtype of metastatic breast cancer. The current standard of care for frontline therapy of patients with luminal metastatic disease is a CDK4/6 inhibitor in combination with endocrine therapy. However, as new endocrine and targeted therapies gain approval, choosing the best systemic therapy upon disease progression after frontline therapy is a topic of ongoing debate. Nearly 40 to 50% of HR-positive breast cancers have actionable genomic alterations and molecular testing should be a routine recommendation for patients with metastatic HR-positive HER2-negative disease. This can be performed repeating tissue biopsy at the time of progression or from archival tissue. Treatment options after progression on CDK4/6 inhibitors include alpelisib in combination with fulvestrant in patients with PIK3CA mutant tumors as seen in the SOLAR-1 trial, or capivasertib with fulvestrant in patients with a tumor mutation in (PI3K)–AKT–PTEN pathway as seen in the CAPItello-291 study, which will be discussed further. In approximately 30% of patients, progression on frontline endocrine plus CDK4/6 inhibitor treatment is caused by endocrine resistance, frequently involving activating mutations in ESR1. For those tumors, elacestrant, an oral SERD is an option as demonstrated in the EMERALD trial. For patients with a BRCA mutation, PARP inhibitors represent another option. If no mutations are detected, everolimus, an mTOR inhibitor, can be used based on the BOLERO-2 results. The phase 2 MAINTAIN and PACE trials, along with the phase 3 postMONARCH trial support changing the endocrine therapy backbone with or without switching the CDK4/6 inhibitor. In less resourced areas, fulvestrant monotherapy is still an option to delay cytotoxic chemotherapy, though its efficacy is limited when used as a single agent. Finally, after progression on at least one line of chemotherapy, antibody drug conjugates including sacituzumab govitecan or trastuzumab deruxtecan may be an option. Now focusing on the PI3K AKT PTEN signaling pathway, activating mutations in PIK3CA and AKT1 and inactivating alterations in PTEN occur in approximately half of luminal breast cancers. In June 2023, the CAPItello-291 trial was published and treatment with fulvestrant plus capivasertib, a PTEN AKT inhibitor, demonstrated a 3.6 month PFS benefit compared to fulvestrant alone, regardless of the presence of AKT pathway alterations. However, for those with tumors without AKT pathway alteration, an exploratory analysis showed that although there was a numerical improvement in PFS, it did not meet statistical significance, indicating that the biomarker positive population primarily drove the positive results noted in the overall population. Therefore, capivasertib plus fulvestrant was approved by the US FDA in November 2023 exclusively for patients with PI3K/AKT1/PTEN tumor alterations after progression on an aromatized inhibitor with or without a CDK4/6 inhibitor. The approved schedule of capivasertib is slightly different from that of other agents used in breast cancer. It is 400 milligrams taken orally twice a day for four days per week every week in a 28-day cycle in combination with fulvestrant. Diarrhea, rash and hyperglycemia were the most commonly reported grade three or four adverse events in the interventional group. I would like to highlight that even though the CAPItello trial excluded patients with glycosylated hemoglobin levels higher than 8% or those diagnosed with diabetes who required insulin, hyperglycemia occurred in 19% of biomarker positive patients treated with capivasertib, with nearly 2% of this population experiencing grade 3 or 4 hyperglycemia and some patients experiencing life threatening outcomes such as diabetic ketoacidosis. By way of comparison, hyperglycemia of any grade was three times higher with alpelisib therapy in the SOLAR-1 trial, occurring in 64% of the patients and grade three or higher hyperglycemia was seen in 37% of the patients. Diarrhea was the most common treatment related adverse event experienced by 77% of the biomarker positive population. Prompt use of the antidiarrheal drugs when needed, such as loperamide must be encouraged as untreated diarrhea can lead to dehydration and renal injury. Cutaneous rash occurred in 56% of the biomarker positive population in the interventional group and 15% experienced a grade 3 or 4 rash. Nearly half of the patients with cutaneous adverse reactions required treatment and this was the leading reason for dose reduction of capivasertib. In the biomarker positive population, the improvement in medium PFS were 4.3 months by investigator assessment. Overall survival data from the CAPItello-291 trial is still immature, but quality of life data was recently published in September this year and was assessed by the 30 item QLQ C30 questionnaire and the QLQ BR23, the breast module. According to Oliveira et al, global health status and quality of life were maintained for a longer period with capivasertib fulvestrant than with placebo fulvestrant except for symptoms of diarrhea which were significantly worse in the capivasertib group. The median time of deterioration of global health status and quality of life was twice as long in the capivasertib group being almost 25 months versus 12 months in the placebo fulvestrant group. These data reinforced the use of capivasertib in combination with fulvestrant for the treatment of HR-positive HER2-negative advanced breast cancer patients with PIK3CA/AKT1/PTEN tumor alterations who have progressed after an aromatase inhibitor-based therapy with or without a CDK4/6 inhibitor. Thank you for listening to JCO Article Insights. This is Giselle Carvalho. Don't forget to give us a rating or review and be sure to subscribe so you never miss an episode. You can find all ASCO shows at asco.org/podcasts. See you next time. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity or therapy should not be construed as an ASCO endorsement.
CME credits: 1.50 Valid until: 30-12-2025 Claim your CME credit at https://reachmd.com/programs/cme/adjuvant-treatments-for-hrher2-ebc-the-role-of-cdk46-and-parp-inhibitors/29826/ Treatment decision-making in breast cancer is complex and incorporates several factors including disease- and patient-related characteristics. The NCCN Clinical Practice Guidelines are regularly updated to provide the most accurate recommendations based on recent scientific evidence and drug approvals. This activity has been designed to review the current NCCN guidelines and the supporting data and explore best practices for selecting therapy based on these recommendations. Explore guideline-based strategies and clinical data to optimize guideline-adherent care for patients with CLL/SLL and MCL.
Send us a textIn this episode, we are thrilled to welcome back Tiffany Troso-Sandoval MD, a distinguished medical oncologist with a quarter-century of experience in women's cancers. Dr. Troso shares her insights from a recent breast cancer symposium, illuminating groundbreaking patient care and treatment strategy advancements. As she shares her journey from the clinic to her broader role in cancer advocacy through her company, Winning The Cancer Journey, Dr. Troso unveils some of her plans aimed at educating and empowering both patients and caregivers.We explore the complex world of metastatic breast cancer treatment, emphasizing estrogen receptor-positive cases. We review the different types of anti-estrogen therapies including how and why they work. We discuss the role of CDK4/6 inhibitors used with aromatase inhibitors, breaking down how these treatments target estrogen pathways to curb cancer growth. We navigate the intricacies of ESR1 mutations and explore how selective estrogen receptor degraders (SERDs) are crucial in overcoming treatment resistance. From chemotherapy timing to empowering caregivers, we delve into the multifaceted nature of breast cancer treatment decisions. Dr. Troso shares her transition from hands-on patient care to creating impactful online resources, highlighting the ongoing nature of the cancer journey for both patients and caregivers. drtiffanytroso@winningthecancerjourney.comDr. Troso on Facebook Winning The Cancer Journey on FacebookDr. Troso on Instagram Winning The Cancer Journey on TikTok San Antonio Breast Cancer Symposium GuideCNN interview: https://www.youtube.com/watch?v=MU38D89YlQ0 Are you loving the Test Those Breasts! Podcast? You can show your support by donating to the Test Those Breasts Nonprofit @ https://testthosebreasts.org/donate/ Where to find Jamie:Instagram LinkedIn TikTok Test Those Breasts Facebook Group LinkTree Jamie Vaughn in the News! Thanks for listening! I would appreciate your rating and review where you listen to podcasts!I am not a doctor and not all information in this podcast comes from qualified healthcare providers, therefore may not constitute medical advice. For personalized medical advice, you should reach out to one of the qualified healthcare providers interviewed on this podcast and/or seek medical advice from your own providers .
In this enlightening episode of The Patient From Hell podcast, Dr. Doug Blayney and host Samira Daswani dive deep into the key insights from the 2024 San Antonio Breast Cancer Symposium (SABCS). They explore four critical areas of breast cancer care: CDK4/6 inhibitors, antibody-drug conjugates (ADCs), de-escalation strategies for ductal carcinoma in situ (DCIS), and the emerging role of artificial intelligence in cancer diagnostics. Throughout the conversation, a central theme emerges: the increasing ability to personalize cancer treatment, considering individual patient characteristics, biological markers, treatment options, and personal goals for quality and quantity of life. Key Highlights: 1. Biomarkers are becoming increasingly sophisticated, allowing for more precise and personalized treatment approaches across different breast cancer subtypes. 2. Patient choice and individual considerations are paramount, with treatment decisions now focusing on balancing potential survival benefits against quality of life impacts. 3. Emerging technologies like antibody-drug conjugates and artificial intelligence are revolutionizing breast cancer care by offering more nuanced, targeted diagnostic and treatment options. About our guest: Dr. Doug Blayney is an oncology physician who specializes in breast cancer and the Chief Medical Officer of Manta Cares. His research focuses on quality improvement in cancer care systems, new drug development, and patient experience improvement. At the American Society of Clinical Oncology (ASCO), he was founding Editor-in-Chief of its flagship practice journal, and as President, started the ASCO Quality Symposium and began planning for ASCO's CancerLinq. He was a founding member of the National Comprehensive Cancer Network (NCCN) Growth Factor Guideline panel, and is a past member of the U.S. Food and Drug Administration's Oncology Drugs Advisory Committee and the NCCN Board of Directors. Key Moments: At 38 minutes: "There's a company now that has a gene expression panel that may predict, and it looks like it does predict, whether radiation treatment after standard treatment for DCIS is beneficial. So if this predicted biomarker of benefit for radiation pans out, and I think it probably will, that means that we can deescalate or personalize whether radiation treatment and its side effects are likely to be beneficial to that patient." At 45 minutes: "Quality of life, can that be answered by a nine question questionnaire? Well, maybe. If you can't get out of bed, your quality of life is because something hurts or if your arm doesn't work because they're so swollen, that's one extreme... What about 15 years playing that duet? What about three? It's those kind of subtleties that we need to take into account." At 49 minutes:"AI can interpret mammograms. The images from a mammogram 20 years ago, there were four, top, bottom, side, side, and maybe another oblique. And now there's 60 images from a mammogram. So that means that a radiologist, a human radiologist, whether it's next door or around the world, somebody needs to look at those. AI can help." Disclaimer: All content and information provided in connection with Manta Cares is solely intended for informational and educational purposes only. This content and information is not intended to be a substitute for medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.
Early Breast Cancer had one of its defining moments in the 1990s, when five years of adjuvant tamoxifen reduced the recurrence risk of invasive breast cancer by 49%! These days, those types of improvements are much harder to substantiate with the effect treatments currently on the market, but there is promise. This week, on our Back to Basics episode, Michael and Josh look at the role of abemaciclib and ribociclib in the adjuvant setting in patients with high-risk early breast cancer. Both of these drugs are CDK4/6 inhibitors and have been shows to be efficacious in the metastatic hormone receptor positive status breast cancer space.This week we explore MONARCH-E and NATALEE and highlight the data and how it could impact CKD's role in this emerging landscape.Studies discussed in the episode:MONARCH-ENATALEEFor more episodes, resources and blog posts, visit www.inquisitiveonc.comPlease find us on Twitter @InquisitiveOnc!If you want us to look at a specific trial or subject, email us at inquisitiveonc@gmail.comArt courtesy of Taryn SilverMusic courtesy of AlisiaBeats: https://pixabay.com/users/alisiabeats-39461785/Disclaimer: This podcast is for educational purposes only. If you are unwell, seek medical advice.Oncology for the Inquisitive Mind is recorded with the support of education grants from our foundation partners Pfizer, Gilead Pharmaceuticals and Merck Pharmaceuticals. Our partners have no editorial rights or early previews, and they have access to the episode at the same time you do. Hosted on Acast. See acast.com/privacy for more information.
Host: Charles Turck, PharmD, BCPS, BCCCP Guest: Hope S. Rugo, MD, FASCO While endocrine therapy (ET) and CDK4/6 inhibitors are the standard for treating ER+/HER2- metastatic breast cancer, patients can become resistant to ET. To overcome these resistance mechanisms, the ELEVATE study examines whether combining elacestrant with ET could help address this unmet need. Here to share the preliminary findings from ELEVATE with Dr. Charles Turck is lead study investigator Dr. Hope Rugo. She's also the Winterhof Distinguished Professor of Breast Oncology and the Director of Breast Oncology and Clinical Trials Education at the University of California, San Francisco Helen Diller Family Comprehensive Cancer Center.
Host: Jennifer Caudle, DO Guest: Virginia Kaklamani, MD Guest: Anne O'Dea, MD When caring for patients with ER-positive/HER2-negative metastatic breast cancer, there's uncertainty on the optimal second-line sequencing of treatments after disease progression on first-line CDK4/6 inhibition and endocrine therapy. But the findings from the EMERALD trial, which led to the approval of ORSERDU® (elacestrant) for patients with ER-positive/HER2-negative ESR1-mutated metastatic breast cancer after disease progression on endocrine therapy,1 contribute to our understanding of second-line treatment options. Dive into the results from the EMERALD trial and subgroup analysis with Drs. Virginia Kaklamani and Anne O'Dea. Dr. Kaklamani is a Professor of Medicine in the Division of Hematology and Medical Oncology at the UT Health Sciences Center in San Antonio, and Dr. O'Dea is a breast medical oncologist at the University of Kansas Cancer Center.
Host: Jennifer Caudle, DO Guest: Virginia Kaklamani, MD Guest: Anne O'Dea, MD When caring for patients with ER-positive/HER2-negative metastatic breast cancer, there's uncertainty on the optimal second-line sequencing of treatments after disease progression on first-line CDK4/6 inhibition and endocrine therapy. But the findings from the EMERALD trial, which led to the approval of ORSERDU® (elacestrant) for patients with ER-positive/HER2-negative ESR1-mutated metastatic breast cancer after disease progression on endocrine therapy,1 contribute to our understanding of second-line treatment options. Dive into the results from the EMERALD trial and subgroup analysis with Drs. Virginia Kaklamani and Anne O'Dea. Dr. Kaklamani is a Professor of Medicine in the Division of Hematology and Medical Oncology at the UT Health Sciences Center in San Antonio, and Dr. O'Dea is a breast medical oncologist at the University of Kansas Cancer Center.
Gain valuable insights into the complexities of diagnosing and managing dedifferentiated liposarcoma (DDLPS) and earn free CME credit with our latest podcast. This episode features expert guidance from Dr. Richard F. Riedel of Duke University and Dr. Candace L. Haddox of Dana-Farber Cancer Institute. Delve into the latest on identifying MDM2 and CDK4 amplification, challenges in diagnosing DDLPS, and updates on emerging therapies like CDK4/6 inhibitors and immunotherapies. Learn how a multidisciplinary approach enhances patient outcomes in this rare and aggressive soft tissue sarcoma. Listen now and advance your expertise! Click here to claim your CME credit: i3health.com/course-information/podcast-ddlps
Featuring an interview with Dr Erika Hamilton, including the following topics: Pathophysiology and pharmacology of ER-positive breast cancer treatment (0:00) Clinical evidence available with oral selective estrogen receptor degraders (3:46) Mechanism of action of proteolysis-targeting chimeras (PROTACs) (13:22) PROTACs currently in clinical development (16:39) Case: A woman in her late 30s with HR-positive, HER2-negative metastatic breast cancer (mBC) experiencing progression on a CDK4/6 inhibitor (CDK4/6i) and an aromatase inhibitor (AI) (35:09) Case: A woman in her early 70s with HR-positive, HER2-negative mBC that progresses on a CDK4/6i and an AI (41:16) CME information and select publications
“CDK4/6 inhibition is considered to be a milestone in the realm of targeted breast cancer therapy. The combination of CDK4/6 inhibitors with the endocrine therapy has really emerged as the foremost therapeutic modality for patients diagnosed with hormone receptor–positive, HER2-negative, advanced breast cancer,” ONS member Teresa Knoop, MSN, RN, AOCN®-emeritus, independent nurse consultant in Nashville, TN, told Jaime Weimer, MSN, RN, AGCNS-BS, AOCNS®, manager of oncology nursing practice at ONS, during the latest episode in our series about anticancer drug classes. Music Credit: “Fireflies and Stardust” by Kevin MacLeod Licensed under Creative Commons by Attribution 3.0 Earn 0.75 contact hours of nursing continuing professional development (NCPD) by listening to the full recording and completing an evaluation at courses.ons.org by October 18, 2026. The planners and faculty for this episode have no relevant financial relationships with ineligible companies to disclose. ONS is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center's Commission on Accreditation. Learning outcome: Learners will report an increase in knowledge related to CDK inhibitors. Episode Notes Complete this evaluation for free NCPD. Oncology Nursing Podcast™ episodes: Pharmacology 101 series Episode 329: Pharmacology 101: BRAF Inhibitors Episode 313: Cancer Symptom Management Basics: Other Pulmonary Complications Episode 295: Cancer Symptom Management Basics: Pulmonary Embolism, Pneumonitis, and Pleural Effusion Episode 80: Patients Need Checkpoint Inhibitor Education Episode 5: New Guidelines for Managing Immunotherapy-Related Adverse Events ONS Voice articles: Combination CDK4/6 and Fulvestrant Has Survival Benefits in Late-Stage Breast Cancer FDA Approves Inavolisib With Palbociclib and Fulvestrant for Endocrine-Resistant, PIK3CA-Variant, HR-Positive, HER2-Negative, Advanced Breast Cancer FDA Approves Ribociclib With an Aromatase Inhibitor and Ribociclib and Letrozole Co-Pack for Early High-Risk Breast Cancer FDA Expands Early Breast Cancer Indication for Abemaciclib With Endocrine Therapy FDA Warns of Rare Lung Inflammation With Certain CDK4/6 Inhibitors Manage Immunotherapy-Related Diarrhea and Colitis Oncology Drug Reference Sheet: Ribociclib The Case of the CTCAE Assessment for CDK4/6 Adverse Events ONS book: Clinical Guide to Antineoplastic Therapy: A Chemotherapy Handbook (fourth edition) Clinical Journal of Oncology Nursing article: Targeted Therapies: Treatment Options for Patients With Metastatic Breast Cancer ONS Symptom Intervention: Prevention of Infection: General ONS Breast Cancer Learning Library ONS CDK4/6 Administration Checklist ONS Oral Anticancer Medication Toolkit Breastcancer.org Susan G. Komen: CDK4/6 Inhibitors Ibrance® (palbociclib) patient site Kisqali® (ribociclib) patient site Verzenio® (abemaciclib) patient site To discuss the information in this episode with other oncology nurses, visit the ONS Communities. To find resources for creating an Oncology Nursing Podcast club in your chapter or nursing community, visit the ONS Podcast Library. To provide feedback or otherwise reach ONS about the podcast, email pubONSVoice@ons.org. Highlights From This Episode “Common toxicity among this class of agents are things like nausea/vomiting, diarrhea, fatigue. All three are associated with low white blood cell counts, which we know as neutropenia, which can cause an increased risk of infection.” TS 10:46 “All three of these CDK4/6 inhibitors are pills taken by mouth, and in most cases they're all given along with endocrine therapy treatments. So, patients will be taking more than one drug. Teach patients how they will take their medication. And the frequency among the three drugs may vary.” TS 13:33 “Patients and caregivers need to know the time of day to take the pills, whether they need to be taken with or without food, or what to do if they miss a dose. We need to help them with a system for organizing the medications. They may find it helpful to use a pill organizer or set reminders on their smartphone, their smartwatch, their computer.” TS 14:29 “Pharmacy and nursing, in my experience, collaborate greatly by determining those drug–drug and drug–food interactions. It is so crucial in determining those interactions and educating our patients because we have to remind patients at each appointment and review these drugs and foods and other things they may be taking, at each appointment. And that often can be done by either pharmacists or nurses or both in collaboration.” TS 23:29 “This class of drug is generally well-tolerated, and I do want nurses to know that that we can help patients with these side effects. And they are generally well-tolerated with appropriate management.” TS 30:55
This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/CPE/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/AGR865. CME/MOC/NCPD/CPE/AAPA/IPCE credit will be available until September 16, 2025.Making Precision Decisions in High-Risk HR+, HER2- Metastatic Breast Cancer: Practical Training on Individualizing CDK4/6 Inhibitor Treatment to Enhance Adherence, Quality of Life, and Outcomes In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an educational grant from Lilly.Disclosure information is available at the beginning of the video presentation.
This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/CPE/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/AGR865. CME/MOC/NCPD/CPE/AAPA/IPCE credit will be available until September 16, 2025.Making Precision Decisions in High-Risk HR+, HER2- Metastatic Breast Cancer: Practical Training on Individualizing CDK4/6 Inhibitor Treatment to Enhance Adherence, Quality of Life, and Outcomes In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an educational grant from Lilly.Disclosure information is available at the beginning of the video presentation.
This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/CPE/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/AGR865. CME/MOC/NCPD/CPE/AAPA/IPCE credit will be available until September 16, 2025.Making Precision Decisions in High-Risk HR+, HER2- Metastatic Breast Cancer: Practical Training on Individualizing CDK4/6 Inhibitor Treatment to Enhance Adherence, Quality of Life, and Outcomes In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an educational grant from Lilly.Disclosure information is available at the beginning of the video presentation.
This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/CPE/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/AGR865. CME/MOC/NCPD/CPE/AAPA/IPCE credit will be available until September 16, 2025.Making Precision Decisions in High-Risk HR+, HER2- Metastatic Breast Cancer: Practical Training on Individualizing CDK4/6 Inhibitor Treatment to Enhance Adherence, Quality of Life, and Outcomes In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an educational grant from Lilly.Disclosure information is available at the beginning of the video presentation.
This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/CPE/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/AGR865. CME/MOC/NCPD/CPE/AAPA/IPCE credit will be available until September 16, 2025.Making Precision Decisions in High-Risk HR+, HER2- Metastatic Breast Cancer: Practical Training on Individualizing CDK4/6 Inhibitor Treatment to Enhance Adherence, Quality of Life, and Outcomes In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an educational grant from Lilly.Disclosure information is available at the beginning of the video presentation.
Drs Park and Graff discuss the evolution of treatment for patients with metastatic HR-positive breast cancer, including the role of CDK4/6 inhibitors.
Featuring an interview with Prof Giuseppe Curigliano, including the following topics: Counseling patients with newly diagnosed metastatic breast cancer (mBC); role of patient-reported outcomes and advocacy (0:00) Individualized selection of up-front therapy for patients with HR-positive, HER2-negative mBC (6:02) Selection and sequencing of treatment for patients with HR-positive, HER2-negative disease who experience progression on CDK4/6 inhibition (9:40) Current and future role of HER2-targeted therapy for HER2-low and HER2-ultralow mBC (19:46) Selection and sequencing of therapy for patients with metastatic triple-negative breast cancer (29:53) Emerging innovative interventions for the treatment of mBC (37:17) CME information and select publications
Featuring an interview with Dr Joyce O'Shaughnessy, including the following topics: Overview of CDK Inhibition for Metastatic Breast Cancer (0:00) Features of High-Risk, HR-Positive, HER2-Negative Localized Breast Cancer (7:45) Sequencing and Selection of CDK4/6 Inhibitors (23:28) Management of Toxicities Associated with CDK Inhibitors and Promoting Patient Adherence (45:47) Review of Clinical Investigator Survey Results (1:01:47) CME information and select publications
Featuring perspectives from Dr Aditya Bardia, Dr Harold J Burstein, Prof Giuseppe Curigliano, Dr Sara A Hurvitz, Dr Hope S Rugo and Dr Joyce O'Shaughnessy, moderated by Dr Rugo, including the following topics: Introduction (0:00) Optimizing the Management of HER2-Positive Metastatic Breast Cancer (mBC) — Dr Hurvitz (4:38) Individualized Selection of Up-Front Therapy for Patients with HR-Positive, HER2-Negative mBC — Dr Burstein (30:11) Selection and Sequencing of Treatment for Patients with HR-Positive, HER2-Negative mBC Who Experience Disease Progression on CDK4/6 Inhibition — Dr Rugo (48:15) Current and Future Role of HER2-Targeted Therapy for HER2-Low and HER2-Ultralow Disease — Prof Curigliano (1:07:24) Selection and Sequencing of Therapy for Patients with Metastatic Triple-Negative Breast Cancer — Dr O'Shaughnessy (1:22:11) Current and Future Strategies for the Care of Individuals with Endocrine-Refractory HR-Positive mBC — Dr Bardia (1:42:24) CME information and select publications
Drs. Claudine Isaacs and Filipa Lynce continue their discussion on the highlights of ASCO 2024 Annual Meeting, with a focus on HER2+ breast cancer. In part two of the discussion, the focus is on two studies pertaining to HER2-positive breast cancer. The first study, the GBCRG-M06 Emerald Study compared the effectiveness and toxicity of eribulin mesylate versus a taxane (with trastuzumab and pertuzumab) in a first-line treatment setting. The study, involving approximately 450 patients, found similar progression-free survival (PFS) between the taxane backbone (13 months) and the eribulin backbone (14 months). However, there was slightly more peripheral neuropathy observed with eribulin. The second study discussed is the Patricia study (cohort C) investigating the use of CDK4-6 inhibitors combined with trastuzumab and endocrine therapy in ER-positive, HER2-positive breast cancer patients who had progressed on prior HER2-targeted therapies. The study indicated an improved PFS with the introduction of CDK4-6 inhibitors (9 months) compared to the control arm (7.5 months). The discussion also anticipates the results of the ongoing PATINA study, which looks to determine whether adding CDK4-6 inhibitors during maintenance therapy will benefit patients with advanced ER-positive, HER2-positive breast cancer.