Faculty

TARGET AUDIENCE
This program is intended for medical oncologists, hematologists, hematology-oncology fellows, oncology surgeons, radiation oncologists and other allied healthcare professionals involved in the treatment of cancer.

LEARNING OBJECTIVES

• Appreciate the pathophysiology of ocular toxicities associated with the administration of specific anticancer therapies for various solid tumors and hematologic cancers.
• Understand the frequency and severity of ocular toxicities observed in pivotal trials evaluating novel agents and strategies demonstrating efficacy in various tumor types, and educate patients about to begin therapy with these approaches regarding the potential development of these adverse events (AEs) and what to do if they are suspected.
• Recall strategies commonly employed to identify, manage and mitigate ocular toxicities in patients receiving anticancer treatment, and use this information to appropriately intervene when these side effects are suspected or diagnosed.
• Appraise the role of multidisciplinary specialists such as ophthalmologists and other eye-care professionals in the diagnosis and management of ocular toxicities, and effectively collaborate with these clinicians to offer best-practice care for patients at high risk for or with a suspected or confirmed diagnosis of these AEs.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Research To Practice designates this enduring material for a maximum of 1.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up to 1.25 Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for each activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology and hematology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
This CME activity consists of a video component. To receive credit, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation located at ResearchToPractice.com/InsideTheIssue2025/OcularToxicities/Part1/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Rebecca A Dent, MD, MSc
Senior Consultant
National Cancer Centre Singapore
Singapore

No relevant financial relationships to disclose.

Hans Lee, MD
Director, Multiple Myeloma Research
Sarah Cannon Research Institute
Nashville, Tennessee

Consulting Agreements: Alexion Pharmaceuticals, Bristol Myers Squibb, GSK, Janssen Biotech Inc, Menarini Group, Pfizer Inc, Regeneron Pharmaceuticals Inc, Sanofi, Takeda Pharmaceuticals USA Inc; Contracted Research: Alexion Pharmaceuticals. Amgen Inc,Bristol Myers Squibb, GSK, Janssen Biotech Inc, Regeneron Pharmaceuticals Inc, Takeda Pharmaceuticals USA Inc; Data and Safety Monitoring Boards/Committees: Allogene Therapeutics, Takeda Pharmaceuticals USA Inc.

Neel Pasricha, MD
Assistant Professor of Ophthalmology
University of California, San Francisco
San Francisco, California

Advisory Committees: AbbVie Inc, AstraZeneca Pharmaceuticals LP, Sanofi; Consulting Agreements: Amgen Inc, Curie.Bio, Vanda Pharmaceuticals Inc.

Tiffany A Richards, PhD, ANP-BC, AOCNP
Nurse Practitioner
Department of Lymphoma/Myeloma
The University of Texas MD Anderson Cancer Center
Houston, Texas

Consulting Agreements: Bristol Myers Squibb, Janssen Biotech Inc, Pfizer Inc, Sanofi, Takeda Pharmaceuticals USA Inc.

MODERATOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Clovis Oncology, Coherus BioSciences, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Hologic Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

These activities are supported by educational grants from AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, and GSK.

Release date: September 2025
Expiration date: September 2026

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Bardia A et al. Datopotamab deruxtecan versus chemotherapy in previously treated inoperable/metastatic hormone receptor–positive human epidermal growth factor receptor 2–negative breast cancer: Primary results from TROPION-Breast01. J Clin Oncol 2025;43(3):285-96. Abstract

Beksac M et al. Baseline ocular conditions and risk of ocular events in patients (pts) with relapsed/refractory multiple myeloma (RRMM) from the DREAMM-7 and DREAMM-8 trials of belantamab mafodotin (belamaf). ASCO 2025;Abstract 7544.

Canestraro J et al. Refractive shifts and changes in corneal curvature associated with antibody-drug conjugates. Cornea 2022;41(6):792-801. Abstract

Fortes BH et al. Ophthalmic adverse effects of immune checkpoint inhibitors: The Mayo Clinic experience. Br J Ophthalmol 2021;105(9):1263-71. Abstract

Francis JH et al. Mitogen-activated pathway kinase inhibitor-associated retinopathy: Do features differ with upstream versus downstream inhibition? Ocul Oncol Pathol 2023;9(1-2):25-31. Abstract

Hattin R et al. Incidence of ocular toxicities in patients with relapsed/refractory multiple myeloma treated with belantamab mafodotin: A systematic review and meta-analysis of phase 3 randomized controlled trials. ASCO 2025;Abstract 12040.

Heist RS et al. Clinical management, monitoring, and prophylaxis of adverse events of special interest associated with datopotamab deruxtecan. Cancer Treat Rev 2024;125:102720. Abstract

Hultcrantz M et al. Belantamab mafodotin monotherapy for relapsed or refractory multiple myeloma: A real-world observational study in the United States. Haematologica 2025;110(3):753-7. Abstract

Hungria V et al. Practical guidance on the clinical management of ocular adverse events associated with belantamab mafodotin for patients with relapsed/refractory multiple myeloma: Latin American expert panel recommendations. Oncol Ther 2025. Abstract

Jhaveri K et al. Datopotamab deruxtecan (Dato-DXd) vs chemotherapy (CT) in pretreated, inoperable/metastatic HR+/HER2– breast cancer (BC): Additional safety analysis from TROPION-Breast01. ESMO Breast 2024;Abstract LBA2.

Kim SK et al. Mitigation and management strategies for ocular events associated with tisotumab vedotin. Gynecol Oncol 2022;165(2):385-92. Abstract

Kleinman D et al. PLL-g-PEG polymer inhibits antibody-drug conjugate uptake into human corneal epithelial cells in vitro. J Ocul Pharmacol Ther 2024;40(7):419-27. Abstract

Landzberg R et al. Portable eye examinations in the oncology clinic: An innovative pilot for clinical trial screening. CERSI Summit 2025.

Lee BA et al. Clinical and histological characterization of toxic keratopathy from depatuxizumab mafodotin (ABT-414), an antibody-drug conjugate. Cornea 2021;40(9):1197-200. Abstract

Lee V et al. Characterization of belantamab mafodotin–induced corneal changes in patients with multiple myeloma. JAMA Ophthalmol 2025;143(6):507-14. Abstract

Lent-Schochet D et al. Ocular surface disease related to tisotumab vedotin-tftv. Gynecol Oncol Rep 2025;57:101676. Abstract

Lindgren ES et al. Incidence and mitigation of corneal pseudomicrocysts induced by antibody–drug conjugates (ADCs). Curr Ophthalmol Rep 2024;12(2):13-22. Abstract

Loberg LI et al. Characterization and potential mitigation of corneal effects in nonclinical toxicology studies in animals administered depatuxizumab mafodotin. J Ocul Pharmacol Ther 2022;38(7):471-80. Abstract

Lu R et al. Management of ocular toxicity in patients receiving belantamab mafodotin. J Adv Pract Oncol 2023;14(4):300-6. Abstract

Mateos M-V et al. Results from the randomized phase III DREAMM-7 study of belantamab mafodotin (belamaf) + bortezomib, and dexamethasone (BVd) vs daratumumab, bortezomib, and dexamethasone (DVd) in relapsed/refractory multiple myeloma (RRMM). ASCO 2024;Abstract 439572.

Munawar U et al. Soluble B-cell maturation antigen in lacrimal fluid as a potential biomarker and mediator of keratopathy in multiple myeloma. Haematologica 2024;109(11):3670-80. Abstract

Pistilli B et al. Datopotamab deruxtecan (Dato-DXd) vs chemotherapy (CT) in previously-treated inoperable or metastatic hormone receptor-positive, HER2-negative (HR+/HER2–) breast cancer (BC): Final overall survival (OS) from the phase III TROPION-Breast01 trial. ESMO Virtual Plenary;Abstract VP1-2025.

Trudel S et al. Results from the randomized phase 3 DREAMM-8 study of belantamab mafodotin plus pomalidomide and dexamethasone (BPd) vs pomalidomide plus bortezomib and dexamethasone (PVd) in relapsed/refractory multiple myeloma (RRMM). ASCO 2024;Abstract LBA105.

Tu Y-P et al. Exposure-response relationships of mirvetuximab soravtansine in patients with folate receptor-α-positive ovarian cancer: Justification of therapeutic dose regimen. Br J Clin Pharmacol 2025;91(1):220-31. Abstract

Usmani SZ et al. Phase I study of belantamab mafodotin in combination with standard of care in transplant-ineligible newly diagnosed multiple myeloma: Dreamm-9 updated interim analysis. ASH 2024;Abstract 497.

Warbington A et al. Nonclinical ocular toxicity of a maytansinoid payload-antibody drug conjugate: Ocular tissue distribution, lesion pathogenesis, and mitigation. AACR 2024;Abstract 2591.

Zhao H et al. Modulation of macropinocytosis-mediated internalization decreases ocular toxicity of antibody-drug conjugates. Cancer Res 2018;78(8):2115-26. Abstract

Faculty

TARGET AUDIENCE
This program is intended for medical and radiation oncologists, hematologists, hematology-oncology fellows, general and breast surgeons and other healthcare providers involved in the treatment of breast cancer.

LEARNING OBJECTIVES

• Evaluate recently presented clinical research findings to determine their effect on the current management of metastatic breast cancer (mBC).
• Review the correlation between various biomarkers (eg, PIK3CA/AKT1/PTEN alterations, ESR1 mutations, low and ultralow HER2 levels) and response to specific therapies, and develop optimal testing algorithms for patients with hormone receptor (HR)-positive mBC.
• Appraise published efficacy and safety data from randomized clinical trials evaluating CDK4/6 inhibitors for HR-positive mBC, and appropriately counsel patients regarding the optimal use of these agents.
• Recall the frequency of phosphoinositide-3 kinase pathway mutations in patients with HR-positive mBC, and recognize the evidence-based approaches available to target these aberrations in individuals with PIK3CA-mutated disease.
• Understand the mechanism of action of, published and emerging research findings with and the current and future clinical role of oral selective estrogen receptor degraders for patients with HR-positive mBC harboring ESR1 mutations.
• Interrogate published Phase III research documenting the efficacy of AKT inhibitors for patients with progressive HR-positive mBC to determine the current clinical applicability of this approach.
• Appreciate the incidence, characteristics and clinical relevance of HER2-low or ultralow mBC, and understand available research findings with HER2-directed antibody-drug conjugates for this disease subset.
• Assess published and emerging Phase III research documenting the efficacy of TROP2-directed antibody-drug conjugates for mBC in order to determine the current and potential clinical applicability of these approaches.
• Evaluate published and emerging research findings and biological and clinical factors to effectively select and sequence available therapeutic agents and regimens for patients with HER2-positive mBC.
• Review published research supporting the use of chemotherapy in combination with anti-PD-1/PD-L1 antibodies for patients with triple-negative mBC, and use this information to make appropriate treatment recommendations.
• Discuss available research establishing the efficacy of PARP inhibitors for patients with mBC harboring BRCA or other homologous recombination repair pathway mutations, and identify individuals appropriate for treatment with these agents.
• Recall the mechanisms of action of, early data with and ongoing clinical trials evaluating other novel agents and treatment strategies under development for mBC.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Video Program: Research To Practice designates this enduring material for a maximum of 2.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation component and a post-test, enables the participant to earn up to 2.25 (video) Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for each activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation component and a post-test, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
Video Program: This CME activity consists of a video component. To receive credit, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation located at ResearchToPractice.com/ASCO2025/mBC/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Harold J Burstein, MD, PhD
Director of Academic Partnerships
Institute Physician
Dana-Farber Cancer Institute
Professor of Medicine
Harvard Medical School
Boston, Massachusetts

No relevant financial relationships to disclose

Javier Cortés, MD, PhD
Head, IBCC International Breast Cancer Center
Barcelona, Spain

Consulting and Advisor: AbbVie Inc, AstraZeneca Pharmaceuticals LP, AvenCell Europe GmbH, Bioasis Technologies Inc, Biocon, BioInvent, BioNTech SE, Bliss Biopharmaceutical (Hangzhou) Co Ltd, Boehringer Ingelheim Pharmaceuticals Inc, Circle Pharma, Daiichi Sankyo Inc, Delcath Systems Inc, Ellipses Pharma, ExpreS2ion Biotechnologies, Gilead Sciences Inc, Hexagon Bio, HiberCell, Jazz Pharmaceuticals Inc, Leuko Labs Inc, Lilly, Menarini Group, MSD, pharmaand GmbH, QED Therapeutics, Reveal Genomics, Roche Laboratories Inc, Seagen Inc, Zymeworks Inc; Contracted Research Funding to Institution: AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Eisai Inc, F Hoffmann-La Roche Ltd, Guardant Health, IQVIA, MSD, Pfizer Inc, PIQUR Therapeutics, Queen Mary University of London, Roche Laboratories Inc, Servier Affaires Medicales, Takeda Pharmaceuticals USA Inc; Honoraria: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Eisai Inc, Gilead Sciences Inc, Lilly, MSD, Novartis, Pfizer Inc, Roche Laboratories Inc, Stemline Therapeutics Inc, Zuellig Pharma; Patents: WO 2014/199294 A, US 2019/0338368 A1; Stock Options/Stock — Public Companies: Leuko Labs Inc; Travel, Accommodation, Expenses: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Eisai Inc, Gilead Sciences Inc, MSD, Novartis, Pfizer Inc, Roche Laboratories Inc, Stemline Therapeutics Inc; Nonrelevant Financial Relationships: MAJ3 Capital.

Rebecca A Dent, MD, MSc
Senior Consultant
National Cancer Centre Singapore
Singapore

No relevant financial relationships to disclose.

Kevin Kalinsky, MD, MS, FASCO
Professor of Medicine
Director, Division of Medical Oncology
Director, Glenn Family Breast Center
Winship Cancer Institute at Emory University
Atlanta, Georgia

Advisory Committees: AstraZeneca Pharmaceuticals LP, Biotheranostics Inc, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Menarini Silicon Biosystems, Merck, Mersana Therapeutics Inc, Myovant Sciences, Novartis, Pfizer Inc, ProteinQure, Puma Biotechnology Inc, Regor Therapeutics, Relay Therapeutics, Seagen Inc.

Joyce O’Shaughnessy, MD
Celebrating Women Chair in Breast Cancer Research
Baylor University Medical Center
Chair, Breast Disease Committee
Sarah Cannon Research Institute
Dallas, Texas

Advisory Committees and Consulting Agreements: Aadi Bioscience, Agendia Inc, Amgen Inc, Aptitude Health, AstraZeneca Pharmaceuticals LP, BioNTech SE, Bristol Myers Squibb, Daiichi Sankyo Inc, Duality Biologics, Eisai Inc, Ellipses Pharma, Exact Sciences Corporation, G1 Therapeutics Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Guardant Health, HiberCell, Jazz Pharmaceuticals Inc, Johnson & Johnson, Lilly, Merck, Mersana Therapeutics Inc, Natera Inc, Novartis, Pfizer Inc, Pierre Fabre, Puma Biotechnology Inc, RayzeBio Inc, Roche Laboratories Inc, Sanofi, Seagen Inc, Stemline Therapeutics Inc, Summit Therapeutics, Tempus, TerSera Therapeutics LLC.

SURVEY PARTICIPANTS
Sara A Hurvitz, MD, FACP — Contracted Research: Ambrx, Amgen Inc, Arvinas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Celcuity, CytomX Therapeutics, Daiichi Sankyo Inc, Dantari, Dignitana AB, G1 Therapeutics Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Greenwich LifeSciences Inc, GSK, Lilly, MacroGenics Inc, Novartis, OBI Pharma Inc, Orinove Inc, Orum Therapeutics, Pfizer Inc, Phoenix Molecular Designs, Pieris Pharmaceuticals Inc, Puma Biotechnology Inc, Radius Health Inc, Samumed, Sanofi, Seagen Inc, Stemline Therapeutics Inc, Zymeworks Inc. Komal Jhaveri, MD, FACP — Consultant/Advisory Board Roles: AstraZeneca Pharmaceuticals LP, Bicycle Therapeutics, Blueprint Medicines, Daiichi Sankyo Inc, Eisai Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Menarini Group, Novartis, Olema Oncology, Pfizer Inc, RayzeBio Inc, Scorpion Therapeutics, Stemline Therapeutics Inc, Zymeworks Inc; Research Funding (Support to Institution): AstraZeneca Pharmaceuticals LP, Blueprint Medicines, Eisai Inc, 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, RayzeBio Inc, Scorpion Therapeutics, Zymeworks Inc; Travel and Accommodations: AstraZeneca Pharmaceuticals LP, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Pfizer Inc.

MODERATOR
Hope S Rugo, MD
Director, Women’s Cancers Program
Division Chief, Breast Medical Oncology
Professor, Department of Medical Oncology and Therapeutics Research
City of Hope Comprehensive Cancer Center
Duarte, California
Professor Emeritus, UCSF

Advisory Committees: Bristol Myers Squibb, Chugai Pharmaceutical Co Ltd, Napo Pharmaceuticals Inc, Sanofi, Viatris; Contracted Research (Institutional Research Support): Ambrx, AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Merck, Novartis, OBI Pharma Inc, Pfizer Inc, Stemline Therapeutics Inc.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

These activities are supported by educational grants from AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Puma Biotechnology Inc, and Stemline Therapeutics Inc.

Release date: June 2025
Expiration date: June 2026

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Dr Cortés

Altaha R et al. Increased risk of brain metastases in patients with HER-2/neu-positive breast carcinoma. Cancer 2005;103(3):442-3. Abstract

Baselga J et al. Case records of the Massachusetts General Hospital. Case 16-2012. A 32-year-old woman with HER2-positive breast cancer. N Engl J Med 2012;366(21):2018-26. Abstract

Bose R et al. Activating HER2 mutations in HER2 gene amplification negative breast cancer. Cancer Discov 2013;3(2):224-37. Abstract

Brufsky A et al. Phase II COLET study: Atezolizumab (A) + cobimetinib (C) + paclitaxel (P)/nab-paclitaxel (nP) as first-line (1L) treatment (tx) for patients (pts) with locally advanced or metastatic triple-negative breast cancer (mTNBC). ASCO 2019;Abstract 1013.

Cortés J et al. Pembrolizumab plus chemotherapy in advanced triple-negative breast cancer. N Engl J Med 2022;387(3):217-26. Abstract

Hyman DM et al. HER kinase inhibition in patients with HER2- and HER3-mutant cancers. Nature 2018;554(7691):189-94. Abstract

Jhaveri K et al. Neratinib + fulvestrant + trastuzumab for HR-positive, HER2-negative, HER2-mutant metastatic breast cancer: outcomes and biomarker analysis from the SUMMIT trial. Ann Oncol 2023;34(10):885-98. Abstract

Lin N et al. Trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2+ advanced/metastatic breast cancer (mBC) with or without brain metastases (BM): DESTINYBreast-12 primary results. ESMO 2024;Abstract LBA18.

Martin M et al. Brain metastases from non-small cell lung carcinoma: An overview of classical and novel treatment strategies. Rep Pract Oncol Radiother 2022;27(3):527-44. Abstract

Metzger O et al. PATINA: A randomized, open label, phase III trial to evaluate the efficacy and safety of palbociclib + anti-HER2 therapy + endocrine therapy vs. anti-HER2 therapy + endocrine therapy after induction treatment for hormone receptor-positive (HR+)/HER2-positive metastatic breast cancer. San Antonio Breast Cancer Symposium 2024;Abstract AFT-38.

Murthy RK et al. Tucatinib, trastuzumab, and capecitabine for HER2-positive metastatic breast cancer. N Engl J Med 2020;382(7):597-609. Abstract

Olson EM et al. Clinical outcomes and treatment practice patterns of patients with HER2-positive metastatic breast cancer in the post-trastuzumab era. Breast 2013;22(4):525-31. Abstract

Rugo HS et al. SOPHIA primary analysis: A phase 3 (P3) study of margetuximab (M) + chemotherapy (C) versus trastuzumab (T) + C in patients (pts) with HER2+ metastatic (met) breast cancer (MBC) after prior anti-HER2 therapies (Tx). ASCO 2019;Abstract 1000.

Tolaney S et al. Trastuzumab deruxtecan (T-DXd) + pertuzumab (P) vs taxane + trastuzumab + pertuzumab (THP) for first-line (1L) treatment of patients (pts) with human epidermal growth factor receptor 2–positive (HER2+) advanced/metastatic breast cancer (a/mBC): Interim results from DESTINY-Breast09. ASCO 2025;Abstract LBA1008.

Verma S et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med 2012;367(19):1783-91. Abstract

 

Dr Kalinsky

Allouchery V et al. Circulating ESR1 mutations at the end of aromatase inhibitor adjuvant treatment and after relapse in breast cancer patients. Breast Cancer Res 2018;20(1):40. Abstract

Bardia A et al. Datopotamab deruxtecan (Dato-DXd) vs chemotherapy in previously-treated inoperable or metastatic hormone receptor-positive, HER2-negative (HR+/HER2–) breast cancer (BC): Primary results from the randomised phase III TROPION-Breast01 trial. ESMO 2023;Abstract LBA11.

Brett JO et al. ESR1 mutation as an emerging clinical biomarker in metastatic hormone receptor-positive breast cancer. Breast Cancer Res 2021;23(1):85. Abstract

Brufsky AM. Long-term management of patients with hormone receptor-positive metastatic breast cancer: Concepts for sequential and combination endocrine-based therapies. Cancer Treat Rev 2017;59:22-32. Abstract

Cabel L et al. Dynamics and type of ESR1 mutations under aromatase inhibitor or fulvestrant combined with palbociclib after randomization in the PADA-1 trial. ASCO 2023;Abstract 1002.

Carlson RW et al. Phase II trial of anastrozole plus goserelin in the treatment of hormone receptor-positive, metastatic carcinoma of the breast in premenopausal women. J Clin Oncol 2010;28(25):3917-21. Abstract

Croxtall JD et al. Fulvestrant: A review of its use in the management of hormone receptor-positive metastatic breast cancer in postmenopausal women. Drugs 2011;71(3):363-80. Abstract

Curigliano G et al. Trastuzumab deruxtecan (T-DXd) vs physician’s choice of chemotherapy (TPC) in patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-low or HER2-ultralow metastatic breast cancer (mBC) with prior endocrine therapy (ET): Primary results from DESTINY-Breast06 (DB-06). ASCO 2024;Abstract LBA1000.

Jeselsohn R et al. Allele-specific chromatin recruitment and therapeutic vulnerabilities of ESR1 activating mutations. Cancer Cell 2018;33(2):173-86.e5. Abstract

Jeselsohn R et al. Emergence of constitutively active estrogen receptor-α mutations in pretreated advanced estrogen receptor-positive breast cancer. Clin Cancer Res 2014;20(7):1757-67. Abstract

Lim E et al. The natural history of hormone receptor-positive breast cancer. Oncology (Williston Park) 2012;26(8):688-94, 696. Abstract

Rugo HS et al. Capivasertib (C) and fulvestrant (F) for patients (pts) with aromatase inhibitor (AI)-resistant HR+/HER2– advanced breast cancer (ABC): Characterization and management of common adverse events (AEs) from the phase 3 CAPItello-291 trial. ASCO 2023;Abstract 1067.

Rugo HS et al. Time course and management of key adverse events during the randomized phase III SOLAR-1 study of PI3K inhibitor alpelisib plus fulvestrant in patients with HR-positive advanced breast cancer. Ann Oncol 2020;31(8):1001-10. Abstract

Schiavon G et al. Analysis of ESR1 mutation in circulating tumor DNA demonstrates evolution during therapy for metastatic breast cancer. Sci Transl Med 2015;7(313):313ra182. Abstract

Turner N et al. INAVO120: Phase III trial final overall survival (OS) analysis of first-line inavolisib (INAVO)/placebo (PBO) + palbociclib (PALBO) + fulvestrant (FULV) in patients (pts) with PIK3CA-mutated, hormone receptor-positive (HR+), HER2-negative (HER2–), endocrine-resistant advanced breast cancer (aBC). ASCO 2025;Abstract 1003.

Vasan N et al. At a crossroads: how to translate the roles of PI3K in oncogenic and metabolic signalling into improvements in cancer therapy. Nat Rev Clin Oncol 2022;19(7):471-85. Abstract

 

Dr Burstein

Bardia A et al. Elacestrant in ER+, HER2- metastatic breast cancer 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

Bardia A et al. Elacestrant vs standard-of-care in ER+/HER2- advanced or metastatic breast cancer (mBC) with ESR1 mutation: Key biomarkers and clinical subgroup analyses from the phase 3 EMERALD trial. San Antonio Breast Cancer Symposium 2023;Abstract PS17-02.

Bidard F-C et al. Elacestrant (oral selective estrogen receptor degrader) versus standard endocrine therapy for estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: Results from the randomized phase III EMERALD trial. J Clin Oncol 2022;40(28):3246-56. Abstract

Hamilton EP et al. Vepdegestrant, a PROTAC estrogen receptor (ER) degrader, vs fulvestrant in ER-positive/human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer: Results of the global, randomized, phase 3 VERITAC-2 study. ASCO 2025;Abstract LBA1000.

Jhaveri KL et al. Imlunestrant with or without abemaciclib in advanced breast cancer. N Engl J Med 2025;392(12):1189-202. Abstract

Jhaveri K 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.

Turner et al. Capivasertib in hormone receptor-positive advanced breast cancer. N Engl J Med 2023;388(22):2058-70. Abstract

 

Dr O’Shaughnessy

Banerji U et al. Trastuzumab duocarmazine in locally advanced and metastatic solid tumours and HER2-expressing breast cancer: A phase 1 dose-escalation and dose-expansion study. Lancet Oncol 2019;20(8):1124-35. Abstract

Bardia A et al. Efficacy and safety of trastuzumab deruxtecan (T-DXd) vs physician’s choice of chemotherapy (TPC) by pace of disease progression on prior endocrine-based therapy: Additional analysis from DESTINY-Breast06. San Antonio Breast Cancer Symposium 2024;Abstract LB1-04.

Bardia A et al. Trastuzumab deruxtecan after endocrine therapy in metastatic breast cancer. N Engl J Med 2024;391(22):2110-22. Abstract

Geukens T et al. Intra-patient and inter-metastasis heterogeneity of HER2-low status in metastatic breast cancer. Eur J Cancer 2023;188:152-60. Abstract

Hurvitz SA et al. TRIO-US B-12 TALENT: Neoadjuvant trastuzumab deruxtecan with or without anastrozole for HER2-low, HR+ early-stage breast cancer. San Antonio Breast Cancer Symposium 2022;Abstract GS2-03.

Miglietta F et al. Evolution of HER2-low expression from primary to recurrent breast cancer. NPJ Breast Cancer 2021;7(1):137. Abstract

Modi S et al. Trastuzumab deruxtecan (T-DXd) versus treatment of physician’s choice (TPC) in patients (pts) with HER2-low unresectable and/or metastatic breast cancer (mBC): Updated survival results of the randomized, phase III DESTINY-Breast04 study. ESMO 2023;Abstract 376O.

Modi S et al. Trastuzumab deruxtecan in previously treated HER2-low advanced breast cancer. N Engl J Med 2022;387(1):9-20. Abstract

Modi S et al. Trastuzumab deruxtecan (T-DXd) versus treatment of physician’s choice (TPC) in patients (pts) with HER2-low unresectable and/or metastatic breast cancer (mBC): Results of DESTINY-Breast04, a randomized, phase 3 study. ASCO 2022;Abstract LBA3.

O’Shaughnessy J et al. DYNASTY-Breast02: A phase III trial of BNT323/DB-1303 vs investigator’s choice chemotherapy in HER2-low, hormone receptor positive, metastatic breast cancer. ESMO 2024;Abstract 436TiP.

Tarantino P et al. Evolution of low HER2 expression between early and advanced-stage breast cancer. Eur J Cancer 2022;163:35-43. Abstract

Wang J et al. RC48-ADC, a HER2-targeting antibody-drug conjugate, in patients with HER2-positive and HER2-low expressing advanced or metastatic breast cancer: A pooled analysis of two studies. ASCO 2021;Abstract 1022.

 

Dr Rugo

Bardia A et al. Datopotamab deruxtecan versus chemotherapy in previously treated inoperable/metastatic hormone receptor-positive human epidermal growth factor receptor 2-negative breast cancer: Primary results from TROPION-Breast01. J Clin Oncol 2025;43(3):285-96. Abstract

Bardia A et al. Randomized phase 3 study of datopotamab deruxtecan vs chemotherapy for patients with previously-treated inoperable or metastatic hormone receptor-positive, HER2-negative breast cancer: Results from TROPION-Breast01. San Antonio Breast Cancer Symposium 2023;Abstract GS02-01.

Columbo R et al. The journey of antibody–drug conjugates: lessons learned from 40 years of development. Cancer Discov 2024;14(11):2089-108. Abstract

Hamilton E et al. Initial phase 1 dose escalation data for emiltatug ledadotin (Emi-Le), a novel B7-H4-directed dolasynthen antibody-drug conjugate. ASCO 2025;Abstract 3009.

Nelson RS et al. UGT1A1 guided cancer therapy: Review of the evidence and considerations for clinical implementation. Cancers (Basel) 2021;13(7):1566. Abstract

Pérez-García JM et al. Prevention of sacituzumab govitecan (SG)-related neutropenia and diarrhea in patients (pts) with triple-negative or HR+/HER2- advanced breast cancer (ABC; PRIMED): A phase 2 trial. ASCO 2024;Abstract 1101.

Pistilli B et al. Datopotamab deruxtecan (Dato-DXd) vs chemotherapy (CT) in previously-treated inoperable or metastatic hormone receptor-positive, HER2-negative (HR+/HER2–) breast cancer (BC): Final overall survival (OS) from the phase III TROPION-Breast01 trial. ESMO 2025;VP1-2025.

Rugo HS et al. Overall survival with sacituzumab govitecan in hormone receptor-positive and human epidermal growth factor receptor 2-negative metastatic breast cancer (TROPiCS-02): A randomised, open-label, multicentre, phase 3 trial. Lancet 2023;402(10411):1423-33. Abstract

Rugo HS et al. Health-related quality of life (HRQoL) in the phase III TROPiCS-02 trial of sacituzumab govitecan (SG) vs chemotherapy in HR+/HER2- metastatic breast cancer (MBC). ESMO 2022;Abstract 1553O. 

Rugo HS et al. Sacituzumab govitecan in hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol 2022;40(29):3365-76. Abstract

Rugo HS et al. Sacituzumab govitecan (SG) vs treatment of physician’s choice (TPC): Efficacy by Trop-2 expression in the TROPiCS-02 study of patients (pts) with HR+/HER2– metastatic breast cancer (mBC). San Antonio Breast Cancer Symposium 2022;Abstract GS1-11.

Rugo HS et al. Safety analyses from the phase 3 ASCENT trial of sacituzumab govitecan in metastatic triple-negative breast cancer. NPJ Breast Cancer 2022;8(1):98. Abstract

Tolaney SM et al. Final overall survival (OS) analysis from the phase 3 TROPiCS-02 study of sacituzumab govitecan (SG) in patients (pts) with hormone receptor–positive/HER2-negative (HR+/HER2–) metastatic breast cancer (mBC). ASCO 2023;Abstract 1003. 

 

Prof Dent

Bardia A et al. Datopotamab deruxtecan in advanced or metastatic HR+/HER2- and triple-negative breast cancer: Results from the phase I TROPION-PanTumor01 study. J Clin Oncol 2024;42(19):2281-94. Abstract

Bardia A et al. Sacituzumab govitecan in metastatic triple-negative breast cancer. N Engl J Med 2021;384(16):1529-41. Abstract

Binghe Xu et al. Sacituzumab tirumotecan (SKB264/MK-2870) in patients (pts) with previously treated locally recurrent or metastatic triple-negative breast cancer (TNBC): Results from the phase III OptiTROP-Breast01 study. ASCO 2024;Abstract 104.

Cortes J et al. Pembrolizumab plus chemotherapy in advanced triple-negative breast cancer. N Engl J Med 2022;387(3):217-26. Abstract

Dent R et al. IMpassion132 double-blind randomised phase III trial of chemotherapy with or without atezolizumab for early relapsing unresectable locally advanced or metastatic triple-negative breast cancer. Ann Oncol 2024;35(7):630-42. Abstract

Giordano A et al. Enfortumab vedotin (EV) in triple-negative breast cancer (TNBC) and HR+/HER2- breast cancer (BC) cohorts of EV-202. ASCO 2024;Abstract 1005.

Krop IE et al. Results from the phase 1/2 study of patritumab deruxtecan, a HER3-directed antibody-drug conjugate (ADC), in patients with HER3-expressing metastatic breast cancer (MBC). ASCO 2022;Abstract 1002.

Litton JK et al. Talazoparib versus chemotherapy in patients with germline BRCA1/2-mutated HER2-negative advanced breast cancer: Final overall survival results from the EMBRACA trial. Ann Oncol 2020;31(11):1526-35. Abstract

Litton JK et al. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. N Engl J Med 2018;379(8):753-63. Abstract

Robson ME et al. OlympiAD extended follow-up for overall survival and safety: Olaparib versus chemotherapy treatment of physician’s choice in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer. Eur J Cancer 2023;184:39-47. Abstract

Robson M et al. Olaparib for metastatic breast cancer in patients with a germline BRCA mutation. N Engl J Med 2017;377(6):523-33. Abstract

Tolaney S et al. Sacituzumab govitecan (SG) + pembrolizumab (pembro) vs chemotherapy (chemo) + pembro in previously untreated PD-L1–positive advanced triple-negative breast cancer (TNBC): Primary results from the randomized phase 3 ASCENT-04/KEYNOTE-D19 study. ASCO 2025;Abstract LBA109.

Tung N et al. TBCRC 031: Randomized phase II study of neoadjuvant cisplatin versus doxorubicin-cyclophosphamide in germline BRCA carriers with HER2-negative breast cancer (the INFORM trial). J Clin Oncol 2020;38(14):1539-48. Abstract

Yin Y et al. Sacituzumab tirumotecan in previously treated metastatic triple-negative breast cancer: a randomized phase 3 trial. Nat Med 2025;[Online ahead of print]. Abstract

Faculty

TARGET AUDIENCE
This program is intended for medical oncologists, hematologists, hematology-oncology fellows, radiation oncologists, surgeons and other allied healthcare professionals involved in the treatment of breast cancer.

LEARNING OBJECTIVES

• Evaluate recently presented clinical research findings to determine their effect on the current management of localized or metastatic breast cancer.
• Review published research data supporting chemotherapy in combination with anti-PD-1/PD-L1 antibodies for localized or metastatic triple-negative breast cancer, and use this information to make appropriate treatment recommendations.
• Appraise published efficacy and safety data from randomized clinical trials evaluating CDK4/6 inhibitors for HR-positive localized or metastatic breast cancer in order to appropriately counsel patients regarding the optimal clinical use of these agents.
• Recognize the frequency of PIK3CA/AKT1/PTEN alterations and ESR1 mutations in patients with HR-positive metastatic breast cancer, and employ evidence-based approaches designed to target these aberrations in HR-positive, HER2-negative disease.
• Evaluate published research findings to effectively inform the selection and sequencing of available therapeutic agents and regimens for HER2-positive localized and metastatic breast cancer.
• Discuss available research establishing the efficacy of PARP inhibitors for patients with localized or metastatic breast cancer harboring BRCA or other homologous recombination repair pathway mutations, and identify individuals appropriate for treatment with these agents.
• Appreciate the incidence, characteristics and clinical relevance of HER2-low or HER2-ultralow metastatic breast cancer, and understand available research findings with HER2-directed antibody-drug conjugates for these patients.
• Interrogate published Phase III research findings documenting the efficacy of TROP2-directed antibody-drug conjugates for metastatic breast cancer to determine the current clinical applicability of these approaches.
• Assess the mechanisms of action of, early data with and ongoing clinical trials evaluating other novel agents and treatment strategies under development for localized and metastatic breast cancer.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Research To Practice designates this enduring material for a maximum of 1.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation component and a post-test, enables the participant to earn up to 1.25 (video) Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for each activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation component and a post-test, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
This CME activity consists of a video component. To receive credit, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation located at ResearchToPractice.com/YiR2024/Breast/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Rebecca A Dent, MD, MSc
Senior Consultant
Deputy Chief Executive Officer (Clinical)
National Cancer Centre Singapore
Singapore

No relevant conflicts of interest to disclose.

Nancy U Lin, MD
Associate Chief, Division of Breast Oncology
Dana-Farber Cancer Institute
Professor of Medicine
Harvard Medical School
Boston, Massachusetts

Consulting Agreements: Artera, AstraZeneca Pharmaceuticals LP, Blueprint Medicines, Daiichi Sankyo Inc, Eisai Inc, Janssen Biotech Inc, Menarini Group, Olema Oncology, Seagen Inc, Shorla Oncology, Stemline Therapeutics Inc; Contracted Research: AstraZeneca Pharmaceuticals LP, Genentech, a member of the Roche Group, Merck, Olema Oncology, Pfizer Inc, Seagen Inc, Zion Pharma; Travel Support: AstraZeneca Pharmaceuticals LP, Olema Oncology.

MODERATOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: AbbVie Inc, ADC Therapeutics, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Clovis Oncology, Coherus BioSciences, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Hologic Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc, Karyopharm Therapeutics, Kite, A Gilead Company, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant conflicts of interest to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

These activities are supported by educational grants from AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Lilly, Novartis, and Puma Biotechnology Inc.

Release date: April 2025
Expiration date: April 2026

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Bardia A et al. Datopotamab deruxtecan versus chemotherapy in previously treated inoperable/metastatic hormone receptor-positive human epidermal growth factor receptor 2-negative breast cancer: Primary results from TROPION-Breast01. J Clin Oncol 2025;43(3):285-96. Abstract

Bardia A et al. Datopotamab deruxtecan in advanced or metastatic HR+/HER2- and triple-negative breast cancer: Results from the Phase I TROPION-PanTumor01 study. J Clin Oncol 2024;42(19):2281-94. Abstract

Bardia A et al. Trastuzumab deruxtecan after endocrine therapy in metastatic breast cancer. N Engl J Med 2024;391(22):2110-22. Abstract

Cortés J et al. Trastuzumab deruxtecan versus trastuzumab emtansine in HER2-positive metastatic breast cancer: Long-term survival analysis of the DESTINY-Breast03 trial. Nat Med 2024;30(8):2208-15. Abstract

Fehm T et al. Trastuzumab deruxtecan versus treatment of physician’s choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): Patient-reported outcomes from a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol 2024;25(5):614-25. Abstract

Freedman RA et al. Neratinib and ado-trastuzumab emtansine for pretreated and untreated human epidermal growth factor receptor 2 (HER2)-positive breast cancer brain metastases: Translational Breast Cancer Research Consortium trial 022. Ann Oncol 2024;35(11):993-1002. Abstract

Garber J et al. OlympiA: A phase 3, multicenter, randomized, placebo-controlled trial of adjuvant olaparib after (neo)adjuvant chemotherapy in patients w/ germline BRCA1 & BRCA2 pathogenic variants & highrisk HER2-negative primary breast cancer. San Antonio Breast Cancer Symposium 2024;Abstract GS1-09.

Geyer CE Jr et al. Survival with trastuzumab emtansine in residual HER2-positive breast cancer. N Engl J Med 2025;392(3):249-57. Abstract

Harbeck N et al. Trastuzumab deruxtecan in HER2-positive advanced breast cancer with or without brain metastases: A phase 3b/4 trial. Nat Med 2024;30(12):3717-27. Abstract

Hortobagyi GN et al. A phase III trial of adjuvant ribociclib plus endocrine therapy versus endocrine therapy alone in patients with HR-positive/HER2-negative early breast cancer: Final invasive disease-free survival results from the NATALEE trial. Ann Oncol 2025;36(2):149-57. Abstract

Jhaveri KL et al. Efficacy and genomic analysis of HER2-mutant, metastatic triple-negative breast cancer treated with neratinib alone or in combination with trastuzumab in the phase 2 SUMMIT basket trial. ASCO 2024;Abstract 1094.

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.

Kalinsky K et al. Abemaciclib plus fulvestrant vs fulvestrant alone for HR+, HER2- advanced breast cancer following progression on a prior CDK4/6 inhibitor plus endocrine therapy: Primary outcome of the phase 3 postMONARCH trial. ASCO 2024;Abstract LBA1001.

Lu Y-S et al. Final results of RIGHT Choice: Ribociclib plus endocrine therapy versus combination chemotherapy in premenopausal women with clinically aggressive hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer. J Clin Oncol 2024;42(23):2812-21. Abstract

Metzger O et al. AFT-38 PATINA: A randomized, open label, Phase III trial to evaluate the efficacy and safety of palbociclib + anti-HER2 therapy + endocrine therapy vs anti-HER2 therapy + endocrine therapy after induction treatment for hormone receptor-positive (HR+)/HER-positive metastatic breast cancer. San Antonio Breast Cancer Symposium 2024;Abstract GS2-12.

Oliveira M et al. Camizestrant, a next-generation oral SERD, versus fulvestrant in post-menopausal women with oestrogen receptor-positive, HER2-negative advanced breast cancer (SERENA-2): A multi-dose, open-label, randomised, phase 2 trial. Lancet Oncol 2024;25(11):1424-39. Abstract

Oliveira M et al. Capivasertib and fulvestrant for patients with hormone receptor-positive, HER2-negative advanced breast cancer (CAPItello-291): Patient-reported outcomes from a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol 2024;25(9):1231-44. Abstract

Pistilli B et al. Datopotamab deruxtecan (Dato-DXd) vs chemotherapy (CT) in previously-treated inoperable or metastatic hormone receptor-positive, HER2-negative (HR+/HER2–) breast cancer (BC): Final overall survival (OS) from the phase III TROPION-Breast01 trial. ESMO Virtual Plenary 2025;Abstract VP1-2025.

Pistilli B et al. Efficacy, safety and biomarker analysis of ICARUS-BREAST01: A phase II study of patritumab deruxtecan (HER3-DXd) in patients (pts) with HR+/HER2- advanced breast cancer (ABC). ESMO 2024;Abstract 340O.

Rastogi P et al. Adjuvant abemaciclib plus endocrine therapy for hormone receptor-positive, human epidermal growth factor receptor 2-negative, high-risk early breast cancer: Results from a preplanned monarchE overall survival interim analysis, including 5-year efficacy outcomes. J Clin Oncol 2024;42(9):987-93. Abstract

Saura C et al. Trastuzumab deruxtecan in previously treated patients with HER2-positive metastatic breast cancer: Updated survival results from a phase II trial (DESTINY-Breast01). Ann Oncol 2024;35(3):302-7. Abstract

Schmid P et al. Neoadjuvant pembrolizumab or placebo plus chemotherapy followed by adjuvant pembrolizumab or placebo for high-risk early-stage TNBC: Overall survival results from the phase III KEYNOTE-522 study. ESMO 2024;Abstract LBA4.

Tarantino P et al. Adjuvant trastuzumab emtansine versus paclitaxel plus trastuzumab for stage I human epidermal growth factor receptor 2-positive breast cancer: 5-year results and correlative analyses from ATEMPT. J Clin Oncol 2024;42(31):3652-65. Abstract

Tung NM et al. TBCRC 048 (olaparib expanded) expansion cohorts: Phase 2 study of olaparib monotherapy in patients (pts) with metastatic breast cancer (MBC) with germline (g) mutations in PALB2 or somatic (s) mutations in BRCA1 or BRCA2. ASCO 2024;Abstract 1021.

Turner NC et al. Inavolisib-based therapy in PIK3CA-mutated advanced breast cancer. N Engl J Med 2024;391(17):1584-96. Abstract

Xu B et al. Sacituzumab tirumotecan (SKB264/MK-2870) in patients (pts) with previously treated locally recurrent or metastatic triple-negative breast cancer (TNBC): Results from the phase III OptiTROP-Breast01 study. ASCO 2024;Abstract 104.

Faculty

TARGET AUDIENCE
This program is intended for medical oncologists, hematologists, hematology-oncology fellows, radiation oncologists, surgeons and other allied healthcare professionals involved in the treatment of breast cancer.

LEARNING OBJECTIVES

• Evaluate recently presented clinical research findings to determine their effect on the current management of localized or metastatic breast cancer.
• Review published research data supporting chemotherapy in combination with anti-PD-1/PD-L1 antibodies for localized or metastatic triple-negative breast cancer, and use this information to make appropriate treatment recommendations.
• Appraise published efficacy and safety data from randomized clinical trials evaluating CDK4/6 inhibitors for HR-positive localized or metastatic breast cancer in order to appropriately counsel patients regarding the optimal clinical use of these agents.
• Recognize the frequency of PIK3CA/AKT1/PTEN alterations and ESR1 mutations in patients with HR-positive metastatic breast cancer, and employ evidence-based approaches designed to target these aberrations in HR-positive, HER2-negative disease.
• Evaluate published research findings to effectively inform the selection and sequencing of available therapeutic agents and regimens for HER2-positive localized and metastatic breast cancer.
• Discuss available research establishing the efficacy of PARP inhibitors for patients with localized or metastatic breast cancer harboring BRCA or other homologous recombination repair pathway mutations, and identify individuals appropriate for treatment with these agents.
• Appreciate the incidence, characteristics and clinical relevance of HER2-low or HER2-ultralow metastatic breast cancer, and understand available research findings with HER2-directed antibody-drug conjugates for these patients.
• Interrogate published Phase III research findings documenting the efficacy of TROP2-directed antibody-drug conjugates for metastatic breast cancer to determine the current clinical applicability of these approaches.
• Assess the mechanisms of action of, early data with and ongoing clinical trials evaluating other novel agents and treatment strategies under development for localized and metastatic breast cancer.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Research To Practice designates this enduring material for a maximum of 1.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of this CME activity, which includes participation in the evaluation component and a post-test, enables the participant to earn up to 1.5 Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of this CME activity, which includes participation in the evaluation component and a post-test, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
This CME activity consists of a video component. To receive credit, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation located at ResearchToPractice.com/YiR2024/Breast/Presentations/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Rebecca A Dent, MD, MSc
Senior Consultant
Deputy Chief Executive Officer (Clinical)
National Cancer Centre Singapore
Singapore

No relevant conflicts of interest to disclose.

Nancy U Lin, MD
Associate Chief, Division of Breast Oncology
Dana-Farber Cancer Institute
Professor of Medicine
Harvard Medical School
Boston, Massachusetts

Consulting Agreements: Artera, AstraZeneca Pharmaceuticals LP, Blueprint Medicines, Daiichi Sankyo Inc, Eisai Inc, Janssen Biotech Inc, Menarini Group, Olema Oncology, Seagen Inc, Shorla Oncology, Stemline Therapeutics Inc; Contracted Research: AstraZeneca Pharmaceuticals LP, Genentech, a member of the Roche Group, Merck, Olema Oncology, Pfizer Inc, Seagen Inc, Zion Pharma; Travel Support: AstraZeneca Pharmaceuticals LP, Olema Oncology.

MODERATOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: AbbVie Inc, ADC Therapeutics, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Clovis Oncology, Coherus BioSciences, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Hologic Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc, Karyopharm Therapeutics, Kite, A Gilead Company, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant conflicts of interest to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

These activities are supported by educational grants from AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Lilly, Novartis, and Puma Biotechnology Inc.

Release date: April 2025
Expiration date: April 2026

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Bardia A et al. Datopotamab deruxtecan versus chemotherapy in previously treated inoperable/metastatic hormone receptor-positive human epidermal growth factor receptor 2-negative breast cancer: Primary results from TROPION-Breast01. J Clin Oncol 2025;43(3):285-96. Abstract

Bardia A et al. Datopotamab deruxtecan in advanced or metastatic HR+/HER2- and triple-negative breast cancer: Results from the Phase I TROPION-PanTumor01 study. J Clin Oncol 2024;42(19):2281-94. Abstract

Bardia A et al. Trastuzumab deruxtecan after endocrine therapy in metastatic breast cancer. N Engl J Med 2024;391(22):2110-22. Abstract

Cortés J et al. Trastuzumab deruxtecan versus trastuzumab emtansine in HER2-positive metastatic breast cancer: Long-term survival analysis of the DESTINY-Breast03 trial. Nat Med 2024;30(8):2208-15. Abstract

Fehm T et al. Trastuzumab deruxtecan versus treatment of physician’s choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): Patient-reported outcomes from a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol 2024;25(5):614-25. Abstract

Freedman RA et al. Neratinib and ado-trastuzumab emtansine for pretreated and untreated human epidermal growth factor receptor 2 (HER2)-positive breast cancer brain metastases: Translational Breast Cancer Research Consortium trial 022. Ann Oncol 2024;35(11):993-1002. Abstract

Garber J et al. OlympiA: A phase 3, multicenter, randomized, placebo-controlled trial of adjuvant olaparib after (neo)adjuvant chemotherapy in patients w/ germline BRCA1 & BRCA2 pathogenic variants & highrisk HER2-negative primary breast cancer. San Antonio Breast Cancer Symposium 2024;Abstract GS1-09.

Geyer CE Jr et al. Survival with trastuzumab emtansine in residual HER2-positive breast cancer. N Engl J Med 2025;392(3):249-57. Abstract

Harbeck N et al. Trastuzumab deruxtecan in HER2-positive advanced breast cancer with or without brain metastases: A phase 3b/4 trial. Nat Med 2024;30(12):3717-27. Abstract

Hortobagyi GN et al. A phase III trial of adjuvant ribociclib plus endocrine therapy versus endocrine therapy alone in patients with HR-positive/HER2-negative early breast cancer: Final invasive disease-free survival results from the NATALEE trial. Ann Oncol 2025;36(2):149-57. Abstract

Jhaveri KL et al. Efficacy and genomic analysis of HER2-mutant, metastatic triple-negative breast cancer treated with neratinib alone or in combination with trastuzumab in the phase 2 SUMMIT basket trial. ASCO 2024;Abstract 1094.

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.

Kalinsky K et al. Abemaciclib plus fulvestrant vs fulvestrant alone for HR+, HER2- advanced breast cancer following progression on a prior CDK4/6 inhibitor plus endocrine therapy: Primary outcome of the phase 3 postMONARCH trial. ASCO 2024;Abstract LBA1001.

Lu Y-S et al. Final results of RIGHT Choice: Ribociclib plus endocrine therapy versus combination chemotherapy in premenopausal women with clinically aggressive hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer. J Clin Oncol 2024;42(23):2812-21. Abstract

Metzger O et al. AFT-38 PATINA: A randomized, open label, Phase III trial to evaluate the efficacy and safety of palbociclib + anti-HER2 therapy + endocrine therapy vs anti-HER2 therapy + endocrine therapy after induction treatment for hormone receptor-positive (HR+)/HER-positive metastatic breast cancer. San Antonio Breast Cancer Symposium 2024;Abstract GS2-12.

Oliveira M et al. Camizestrant, a next-generation oral SERD, versus fulvestrant in post-menopausal women with oestrogen receptor-positive, HER2-negative advanced breast cancer (SERENA-2): A multi-dose, open-label, randomised, phase 2 trial. Lancet Oncol 2024;25(11):1424-39. Abstract

Oliveira M et al. Capivasertib and fulvestrant for patients with hormone receptor-positive, HER2-negative advanced breast cancer (CAPItello-291): Patient-reported outcomes from a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol 2024;25(9):1231-44. Abstract

Pistilli B et al. Datopotamab deruxtecan (Dato-DXd) vs chemotherapy (CT) in previously-treated inoperable or metastatic hormone receptor-positive, HER2-negative (HR+/HER2–) breast cancer (BC): Final overall survival (OS) from the phase III TROPION-Breast01 trial. ESMO Virtual Plenary 2025;Abstract VP1-2025.

Pistilli B et al. Efficacy, safety and biomarker analysis of ICARUS-BREAST01: A phase II study of patritumab deruxtecan (HER3-DXd) in patients (pts) with HR+/HER2- advanced breast cancer (ABC). ESMO 2024;Abstract 340O.

Rastogi P et al. Adjuvant abemaciclib plus endocrine therapy for hormone receptor-positive, human epidermal growth factor receptor 2-negative, high-risk early breast cancer: Results from a preplanned monarchE overall survival interim analysis, including 5-year efficacy outcomes. J Clin Oncol 2024;42(9):987-93. Abstract

Saura C et al. Trastuzumab deruxtecan in previously treated patients with HER2-positive metastatic breast cancer: Updated survival results from a phase II trial (DESTINY-Breast01). Ann Oncol 2024;35(3):302-7. Abstract

Schmid P et al. Neoadjuvant pembrolizumab or placebo plus chemotherapy followed by adjuvant pembrolizumab or placebo for high-risk early-stage TNBC: Overall survival results from the phase III KEYNOTE-522 study. ESMO 2024;Abstract LBA4.

Tarantino P et al. Adjuvant trastuzumab emtansine versus paclitaxel plus trastuzumab for stage I human epidermal growth factor receptor 2-positive breast cancer: 5-year results and correlative analyses from ATEMPT. J Clin Oncol 2024;42(31):3652-65. Abstract

Tung NM et al. TBCRC 048 (olaparib expanded) expansion cohorts: Phase 2 study of olaparib monotherapy in patients (pts) with metastatic breast cancer (MBC) with germline (g) mutations in PALB2 or somatic (s) mutations in BRCA1 or BRCA2. ASCO 2024;Abstract 1021.

Turner NC et al. Inavolisib-based therapy in PIK3CA-mutated advanced breast cancer. N Engl J Med 2024;391(17):1584-96. Abstract

Xu B et al. Sacituzumab tirumotecan (SKB264/MK-2870) in patients (pts) with previously treated locally recurrent or metastatic triple-negative breast cancer (TNBC): Results from the phase III OptiTROP-Breast01 study. ASCO 2024;Abstract 104.

Faculty

TARGET AUDIENCE
This program is intended for medical oncologists, hematologists, hematology-oncology fellows, radiation oncologists, surgeons and other allied healthcare professionals involved in the treatment of breast cancer.

LEARNING OBJECTIVES

• Evaluate recently presented clinical research findings to determine their effect on the current management of localized or metastatic breast cancer.
• Review published research data supporting chemotherapy in combination with anti-PD-1/PD-L1 antibodies for localized or metastatic triple-negative breast cancer, and use this information to make appropriate treatment recommendations.
• Appraise published efficacy and safety data from randomized clinical trials evaluating CDK4/6 inhibitors for HR-positive localized or metastatic breast cancer in order to appropriately counsel patients regarding the optimal clinical use of these agents.
• Recognize the frequency of PIK3CA/AKT1/PTEN alterations and ESR1 mutations in patients with HR-positive metastatic breast cancer, and employ evidence-based approaches designed to target these aberrations in HR-positive, HER2-negative disease.
• Evaluate published research findings to effectively inform the selection and sequencing of available therapeutic agents and regimens for HER2-positive localized and metastatic breast cancer.
• Discuss available research establishing the efficacy of PARP inhibitors for patients with localized or metastatic breast cancer harboring BRCA or other homologous recombination repair pathway mutations, and identify individuals appropriate for treatment with these agents.
• Appreciate the incidence, characteristics and clinical relevance of HER2-low or HER2-ultralow metastatic breast cancer, and understand available research findings with HER2-directed antibody-drug conjugates for these patients.
• Interrogate published Phase III research findings documenting the efficacy of TROP2-directed antibody-drug conjugates for metastatic breast cancer to determine the current clinical applicability of these approaches.
• Assess the mechanisms of action of, early data with and ongoing clinical trials evaluating other novel agents and treatment strategies under development for localized and metastatic breast cancer.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Research To Practice designates this enduring material for a maximum of 1.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of this CME activity, which includes participation in the evaluation component and a post-test, enables the participant to earn up to 1.5 Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of this CME activity, which includes participation in the evaluation component and a post-test, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
This CME activity consists of a video component. To receive credit, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation located at ResearchToPractice.com/YiR2024/Breast/Presentations/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Rebecca A Dent, MD, MSc
Senior Consultant
Deputy Chief Executive Officer (Clinical)
National Cancer Centre Singapore
Singapore

No relevant conflicts of interest to disclose.

Nancy U Lin, MD
Associate Chief, Division of Breast Oncology
Dana-Farber Cancer Institute
Professor of Medicine
Harvard Medical School
Boston, Massachusetts

Consulting Agreements: Artera, AstraZeneca Pharmaceuticals LP, Blueprint Medicines, Daiichi Sankyo Inc, Eisai Inc, Janssen Biotech Inc, Menarini Group, Olema Oncology, Seagen Inc, Shorla Oncology, Stemline Therapeutics Inc; Contracted Research: AstraZeneca Pharmaceuticals LP, Genentech, a member of the Roche Group, Merck, Olema Oncology, Pfizer Inc, Seagen Inc, Zion Pharma; Travel Support: AstraZeneca Pharmaceuticals LP, Olema Oncology.

MODERATOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: AbbVie Inc, ADC Therapeutics, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Clovis Oncology, Coherus BioSciences, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Hologic Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc, Karyopharm Therapeutics, Kite, A Gilead Company, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant conflicts of interest to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

These activities are supported by educational grants from AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Lilly, Novartis, and Puma Biotechnology Inc.

Release date: April 2025
Expiration date: April 2026

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Bardia A et al. Datopotamab deruxtecan versus chemotherapy in previously treated inoperable/metastatic hormone receptor-positive human epidermal growth factor receptor 2-negative breast cancer: Primary results from TROPION-Breast01. J Clin Oncol 2025;43(3):285-96. Abstract

Bardia A et al. Datopotamab deruxtecan in advanced or metastatic HR+/HER2- and triple-negative breast cancer: Results from the Phase I TROPION-PanTumor01 study. J Clin Oncol 2024;42(19):2281-94. Abstract

Bardia A et al. Trastuzumab deruxtecan after endocrine therapy in metastatic breast cancer. N Engl J Med 2024;391(22):2110-22. Abstract

Cortés J et al. Trastuzumab deruxtecan versus trastuzumab emtansine in HER2-positive metastatic breast cancer: Long-term survival analysis of the DESTINY-Breast03 trial. Nat Med 2024;30(8):2208-15. Abstract

Fehm T et al. Trastuzumab deruxtecan versus treatment of physician’s choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): Patient-reported outcomes from a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol 2024;25(5):614-25. Abstract

Freedman RA et al. Neratinib and ado-trastuzumab emtansine for pretreated and untreated human epidermal growth factor receptor 2 (HER2)-positive breast cancer brain metastases: Translational Breast Cancer Research Consortium trial 022. Ann Oncol 2024;35(11):993-1002. Abstract

Garber J et al. OlympiA: A phase 3, multicenter, randomized, placebo-controlled trial of adjuvant olaparib after (neo)adjuvant chemotherapy in patients w/ germline BRCA1 & BRCA2 pathogenic variants & highrisk HER2-negative primary breast cancer. San Antonio Breast Cancer Symposium 2024;Abstract GS1-09.

Geyer CE Jr et al. Survival with trastuzumab emtansine in residual HER2-positive breast cancer. N Engl J Med 2025;392(3):249-57. Abstract

Harbeck N et al. Trastuzumab deruxtecan in HER2-positive advanced breast cancer with or without brain metastases: A phase 3b/4 trial. Nat Med 2024;30(12):3717-27. Abstract

Hortobagyi GN et al. A phase III trial of adjuvant ribociclib plus endocrine therapy versus endocrine therapy alone in patients with HR-positive/HER2-negative early breast cancer: Final invasive disease-free survival results from the NATALEE trial. Ann Oncol 2025;36(2):149-57. Abstract

Jhaveri KL et al. Efficacy and genomic analysis of HER2-mutant, metastatic triple-negative breast cancer treated with neratinib alone or in combination with trastuzumab in the phase 2 SUMMIT basket trial. ASCO 2024;Abstract 1094.

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.

Kalinsky K et al. Abemaciclib plus fulvestrant vs fulvestrant alone for HR+, HER2- advanced breast cancer following progression on a prior CDK4/6 inhibitor plus endocrine therapy: Primary outcome of the phase 3 postMONARCH trial. ASCO 2024;Abstract LBA1001.

Lu Y-S et al. Final results of RIGHT Choice: Ribociclib plus endocrine therapy versus combination chemotherapy in premenopausal women with clinically aggressive hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer. J Clin Oncol 2024;42(23):2812-21. Abstract

Metzger O et al. AFT-38 PATINA: A randomized, open label, Phase III trial to evaluate the efficacy and safety of palbociclib + anti-HER2 therapy + endocrine therapy vs anti-HER2 therapy + endocrine therapy after induction treatment for hormone receptor-positive (HR+)/HER-positive metastatic breast cancer. San Antonio Breast Cancer Symposium 2024;Abstract GS2-12.

Oliveira M et al. Camizestrant, a next-generation oral SERD, versus fulvestrant in post-menopausal women with oestrogen receptor-positive, HER2-negative advanced breast cancer (SERENA-2): A multi-dose, open-label, randomised, phase 2 trial. Lancet Oncol 2024;25(11):1424-39. Abstract

Oliveira M et al. Capivasertib and fulvestrant for patients with hormone receptor-positive, HER2-negative advanced breast cancer (CAPItello-291): Patient-reported outcomes from a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol 2024;25(9):1231-44. Abstract

Pistilli B et al. Datopotamab deruxtecan (Dato-DXd) vs chemotherapy (CT) in previously-treated inoperable or metastatic hormone receptor-positive, HER2-negative (HR+/HER2–) breast cancer (BC): Final overall survival (OS) from the phase III TROPION-Breast01 trial. ESMO Virtual Plenary 2025;Abstract VP1-2025.

Pistilli B et al. Efficacy, safety and biomarker analysis of ICARUS-BREAST01: A phase II study of patritumab deruxtecan (HER3-DXd) in patients (pts) with HR+/HER2- advanced breast cancer (ABC). ESMO 2024;Abstract 340O.

Rastogi P et al. Adjuvant abemaciclib plus endocrine therapy for hormone receptor-positive, human epidermal growth factor receptor 2-negative, high-risk early breast cancer: Results from a preplanned monarchE overall survival interim analysis, including 5-year efficacy outcomes. J Clin Oncol 2024;42(9):987-93. Abstract

Saura C et al. Trastuzumab deruxtecan in previously treated patients with HER2-positive metastatic breast cancer: Updated survival results from a phase II trial (DESTINY-Breast01). Ann Oncol 2024;35(3):302-7. Abstract

Schmid P et al. Neoadjuvant pembrolizumab or placebo plus chemotherapy followed by adjuvant pembrolizumab or placebo for high-risk early-stage TNBC: Overall survival results from the phase III KEYNOTE-522 study. ESMO 2024;Abstract LBA4.

Tarantino P et al. Adjuvant trastuzumab emtansine versus paclitaxel plus trastuzumab for stage I human epidermal growth factor receptor 2-positive breast cancer: 5-year results and correlative analyses from ATEMPT. J Clin Oncol 2024;42(31):3652-65. Abstract

Tung NM et al. TBCRC 048 (olaparib expanded) expansion cohorts: Phase 2 study of olaparib monotherapy in patients (pts) with metastatic breast cancer (MBC) with germline (g) mutations in PALB2 or somatic (s) mutations in BRCA1 or BRCA2. ASCO 2024;Abstract 1021.

Turner NC et al. Inavolisib-based therapy in PIK3CA-mutated advanced breast cancer. N Engl J Med 2024;391(17):1584-96. Abstract

Xu B et al. Sacituzumab tirumotecan (SKB264/MK-2870) in patients (pts) with previously treated locally recurrent or metastatic triple-negative breast cancer (TNBC): Results from the phase III OptiTROP-Breast01 study. ASCO 2024;Abstract 104.