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Dissecting the Decision: Optimizing the Use of CDK4/6 Inhibitors in the Management of ER-Positive, HER2-Negative Metastatic Breast Cancer
Released June 2019

Featuring a roundtable discussion with Drs Neelima Denduluri, Shom Goel, Erika Hamilton, Komal Jhaveri, Ruth M O’Regan and Sara M Tolaney. (Audio Program)

CE Information and Faculty Disclosures

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

    OVERVIEW OF ACTIVITY
    Individualized treatment decisions for patients with metastatic breast cancer are driven by disease and patient characteristics. Estrogen receptor (ER)-positive disease, which represents approximately 65% of all cases, is perhaps the most nuanced in regard to therapeutic decision-making in the advanced-disease setting. In recent years, several groundbreaking clinical data sets and related FDA actions have significantly and unprecedentedly altered the treatment algorithm for patients with ER-positive metastatic breast cancer. Foremost among these developments have been the recent FDA approvals of the cyclin-dependent kinase (CDK) 4 and 6 inhibitors palbociclib, ribociclib and abemaciclib. Many areas of controversy and educational need exist within community practice, specifically in the management of ER-positive metastatic disease and the integration of CDK4/6 inhibitors into routine care. This program will present the perspectives of leading clinical investigators to provide clinicians with therapeutic strategies to address the disparate needs of patients with ER-positive metastatic breast cancer. Upon completion of this CME activity, medical oncologists should be able to formulate an up-to-date and more complete approach to the care of these patients.

    LEARNING OBJECTIVES

    • Appraise the mechanism by which the CDK pathway contributes to breast cancer proliferation and growth, and recognize how the inhibition of CDK4/6 has improved outcomes for patients with ER-positive metastatic disease.
    • Implement a clinical plan for the management of ER-positive metastatic breast cancer, considering the patient’s clinical presentation, prior treatment course and psychosocial status.
    • Assess how the FDA-approved CDK4/6 inhibitors abemaciclib, palbociclib and ribociclib can be optimally integrated into the management of ER-positive metastatic breast cancer.
    • Develop an optimal approach to local and systemic therapy for patients with ER-positive breast cancer and CNS metastases, considering the implications of symptomatology, number of lesions and other factors.
    • Appreciate the unique side effects associated with CDK4/6 inhibitors, and develop preventive and emergent strategies to reduce or ameliorate these toxicities.

    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
    Audio Program: Research To Practice designates this enduring material for a maximum of 2.75 AMA PRA Category 1 Credits. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

    Video Program: Research To Practice designates this enduring material for a maximum of 2.75 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, enables the participant to earn up to 2.75 (audio) and 2.75 (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.

    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 THESE CME ACTIVITIES
    Audio Program: This CME activity consists of an audio component. To receive credit, the participant should review the CME information, listen to the MP3s, complete the Post-test with a score of 80% or better and fill out the Educational Assessment and Credit Form located at ResearchToPractice.com/ERMBC19/CME. The corresponding video program is available as an alternative at ResearchToPractice.com/ERMBC19/Video.

    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 Educational Assessment and Credit Form located at ResearchToPractice.com/ERMBC19/Video/CME. The corresponding audio program is available as an alternative at ResearchToPractice.com/ERMBC19.

    CONTENT VALIDATION AND DISCLOSURES
    Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education. We assess conflicts of interest with faculty, planners and managers of CME activities. Conflicts of interest are identified and resolved through a conflict of interest resolution process. In addition, all activity content is reviewed by both a member of the 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 (and their spouses/partners) reported relevant conflicts of interest, which have been resolved through a conflict of interest resolution process:

    Co-Chair

    Sara M Tolaney, MD, MPH
    Associate Director, Susan F Smith Center for Women’s Cancers
    Director of Clinical Trials, Breast Oncology
    Director of Breast Immunotherapy Clinical Research
    Senior Physician
    Breast Oncology Program
    Dana-Farber Cancer Institute
    Assistant Professor of Medicine
    Harvard Medical School
    Boston, Massachusetts

    Advisory Committee: AstraZeneca Pharmaceuticals LP, Celldex Therapeutics Inc, Eisai Inc, Genentech, Immunomedics Inc, Lilly, Merck, NanoString Technologies, Nektar, Novartis, Pfizer Inc, Puma Biotechnology Inc, Roche Laboratories Inc, Sanofi Genzyme; Consulting Agreements: AstraZeneca Pharmaceuticals LP, Eisai Inc, Lilly, Merck, NanoString Technologies, Nektar, Novartis, Pfizer Inc, Tesaro; Contracted Research: AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Company, Cyclacel Pharmaceuticals Inc, Eisai Inc, Exelixis Inc, Genentech, Lilly, Merck, NanoString Technologies, Nektar, Novartis, Pfizer Inc, Roche Laboratories Inc.

    Faculty

    Neelima Denduluri, MD
    Associate Chair, US Oncology Breast Cancer Research Committee
    Medical Oncologist
    Virginia Cancer Specialists
    Arlington, Virginia

    Advisory Committee: Daiichi Sankyo Inc; Contracted Research: Amgen Inc, Genentech, GTx Inc, Novartis; Unpaid Consulting Agreement: Genomic Health Inc.

    Shom Goel, MBBS, PhD
    Instructor in Medicine
    Dana-Farber Cancer Institute
    Harvard Medical School
    Boston, Massachusetts

    Advisory Committee: G1 Therapeutics, Lilly, Novartis; Consulting Agreements, Contracted Research and Speakers Bureau: Lilly.

    Erika Hamilton, MD
    Director, Breast and Gynecologic Research Program
    Sarah Cannon Research Institute
    Nashville, Tennessee

    Advisory Committee: Boehringer Ingelheim Pharmaceuticals Inc, Daiichi Sankyo Inc, Eisai Inc, Flatiron Health, Genentech, Lilly, Mersana Therapeutics, Pfizer Inc, Puma Biotechnology Inc, Roche Laboratories Inc, Seattle Genetics; Contracted Research: AbbVie Inc, Acerta Pharma — A member of the AstraZeneca Group, ArQule Inc, AstraZeneca Pharmaceuticals LP, BerGenBio ASA, Boehringer Ingelheim Pharmaceuticals Inc, Clovis Oncology, Curis Inc, CytomX Therapeutics, Daiichi Sankyo Inc, Deciphera Pharmaceuticals Inc, eFFECTOR Therapeutics Inc, Eisai Inc, EMD Serono Inc, FUJIFILM Pharmaceuticals USA Inc, Genentech, H3 Biomedicine Inc, Hutchison MediPharma, Immunomedics Inc, InventisBio, Kadmon Holdings Inc, Leap Therapeutics Inc, Lilly, Lycera, MacroGenics Inc, Mallinckrodt Pharmaceuticals, Marker Therapeutics Inc, Medivation Inc, a Pfizer Company, Mersana Therapeutics, Merus BV, Novartis, NuCana, OncoMed Pharmaceuticals Inc, Pfizer Inc, PharmaMar, Radius Health Inc, Regeneron Pharmaceuticals Inc, Rgenix, Roche Laboratories Inc, Seattle Genetics, Stemcentrx, Syndax Pharmaceuticals Inc, Syros Pharmaceuticals Inc, Taiho Oncology Inc, Takeda Oncology, Tesaro, TetraLogic Pharmaceuticals, Verastem Inc, Zymeworks; Paid Travel: Amgen Inc, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Bristol-Myers Squibb Company, Clovis Oncology, Eisai Inc, EMD Serono Inc, Foundation Medicine, Genentech, Genzyme Corporation, Guardant Health, Helsinn Group, Heron Therapeutics, Lexicon Pharmaceuticals Inc, Lilly, Medivation Inc, a Pfizer Company, Merck, Novartis, Pfizer Inc, Roche Laboratories Inc, Sysmex Corporation, Tesaro.

    Komal Jhaveri, MD
    Assistant Attending, Breast Medicine and Early Drug Development Services
    Department of Medicine
    Memorial Sloan Kettering Cancer Center
    New York, New York

    Consulting Agreements: ADC Therapeutics SA, Jounce Therapeutics, Novartis, Pfizer Inc, Spectrum Pharmaceuticals Inc, Taiho Oncology Inc; Contracted Research: ADC Therapeutics SA, Debiopharm Group, Genentech, Lilly, Novartis, Novita Pharmaceuticals, Pfizer Inc; Data and Safety Monitoring Board/Committee: Synthon Pharmaceuticals Inc.

    Ruth M O’Regan, MD
    Professor of Medicine
    Chief, Division of Hematology/Oncology
    University of Wisconsin Carbone Cancer Center
    Madison, Wisconsin

    Advisory Committee: bioTheranostics Inc, Genentech, Genomic Health Inc, Immunomedics Inc, MacroGenics Inc, Novartis, Pfizer Inc, Puma Biotechnology Inc; Contracted Research: Eisai Inc, Novartis, Pfizer Inc, Seattle Genetics.

    MODERATORDr 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 commercial interests: AbbVie Inc, Acerta Pharma — A member of the AstraZeneca Group, Adaptive Biotechnologies, Agendia Inc, Agios Pharmaceuticals Inc, Amgen Inc, Ariad Pharmaceuticals Inc, Array BioPharma Inc, Astellas Pharma Global Development Inc, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Biodesix Inc, bioTheranostics Inc, Boehringer Ingelheim Pharmaceuticals Inc, Boston Biomedical Inc, Bristol-Myers Squibb Company, Celgene Corporation, Clovis Oncology, Daiichi Sankyo Inc, Dendreon Pharmaceuticals Inc, Eisai Inc, Exelixis Inc, Foundation Medicine, Genentech, Genmab, Genomic Health Inc, Gilead Sciences Inc, Guardant Health, Halozyme Inc, ImmunoGen Inc, Incyte Corporation, Infinity Pharmaceuticals Inc, Ipsen Biopharmaceuticals Inc, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc, Kite Pharma Inc, Lexicon Pharmaceuticals Inc, Lilly, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Merck, Merrimack Pharmaceuticals Inc, Myriad Genetic Laboratories Inc, Natera Inc, Novartis, Oncopeptides, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Prometheus Laboratories Inc, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Sandoz Inc, a Novartis Division, Sanofi Genzyme, Seattle Genetics, Sirtex Medical Ltd, Spectrum Pharmaceuticals Inc, Taiho Oncology Inc, Takeda Oncology, Tesaro, Teva Oncology, Tokai Pharmaceuticals Inc and Tolero Pharmaceuticals.

    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.

    This educational activity contains 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 grantor.

    This activity is supported by an educational grant from Lilly.

    Hardware/Software Requirements:
    A high-speed Internet connection
    A monitor set to 1280 x 1024 pixels or more
    Internet Explorer 11 or later, Firefox 56 or later, Chrome 61 or later, Safari 11 or later, Opera 48 or later
    Adobe Flash Player 27 plug-in or later
    Adobe Acrobat Reader
    (Optional) Sound card and speakers for audio

    Release date: June 2019
    Expiration date: June 2020

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Dissecting the Decision: Optimizing the Use of CDK4/6 Inhibitors in the Management of ER-Positive, HER2-Negative Metastatic Breast Cancer
Released June 2019

Featuring a roundtable discussion with Drs Neelima Denduluri, Shom Goel, Erika Hamilton, Komal Jhaveri, Ruth M O’Regan and Sara M Tolaney. (Audio Program)

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