Join us on Wednesday, June 23^rd for this CME/MOC-accredited webinar
5:00 PM – 6:00 PM ET

Not an official event of the 2021 ASCO Annual Meeting. Not sponsored, endorsed, or accredited by ASCO^®, CancerLinQ^®, or Conquer Cancer^® the ASCO Foundation.

This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Exact Sciences Inc, Lilly, Merck, Novartis, Puma Biotechnology Inc and Seagen Inc.

Module 1: Evolving Clinical Decision-Making for Patients with ER-Positive Localized Breast Cancer

• Design, eligibility criteria and major clinical findings from the Phase III RxPONDER trial evaluating the role of chemotherapy for patients with ER-positive, HER2-negative early breast cancer with 1 to 3 positive lymph nodes and a 21-gene Recurrence Score^® (RS) of ≤25; implications for clinical practice
• Benefit associated with chemotherapy for premenopausal versus postmenopausal patients in RxPONDER; current role of the 21-gene RS for premenopausal patients with node-positive disease
• Other recent clinical trial findings informing the use of genomic assays to guide neoadjuvant and adjuvant treatment decision-making
• Biologic rationale for the evaluation of CDK4/6 inhibitors for localized ER/PR-positive, HER2- negative breast cancer
• Improvement in invasive disease-free survival observed with the addition of abemaciclib to standard adjuvant hormonal therapy for patients with ER-positive, HER2-negative breast cancer at high risk for recurrence in the Phase III monarchE trial
• Spectrum, frequency and severity of toxicities reported with abemaciclib in monarchE; rates of discontinuation before 2 years of treatment
• Clinical and research implications of positive results from monarchE and the potential role of adjuvant abemaciclib for localized ER-positive breast cancer
• Key efficacy and safety findings from the Phase III PALLAS and PENELOPE-B trials evaluating palbociclib in combination with standard adjuvant endocrine therapy for localized ER-positive, HER2-negative breast cancer

Module 2: Selection and Sequencing of Therapy for ER-Positive, HER2-Negative Metastatic Breast Cancer (mBC)

• Long-term follow-up data with a CDK4/6 inhibitor — palbociclib, ribociclib or abemaciclib — and an endocrine partner for patients with ER-positive mBC; factors in the selection of an agent
• Proposed mechanisms of resistance to CDK4/6 inhibition; incidence, identification and prognostic significance of PIK3CA mutations in patients with ER-positive mBC
• Published research findings with alpelisib/fulvestrant for patients with ER-positive mBC with a PIK3CA mutation; Phase II BYLieve study affirming the utility of this combination after disease progression on a CDK4/6 inhibitor
• Spectrum, frequency and severity of alpelisib-related toxicities; optimal prevention and management strategies
• Other novel agents and strategies under investigation for ER-positive mBC (eg, capivasertib, venetoclax, patritumab deruxtecan)

Module 3: Immune Checkpoint Inhibitors and Other Novel Strategies for the Treatment of Triple-Negative Breast Cancer (TNBC)

• Available results from the Phase III KEYNOTE-522 and IMpassion031 trials documenting the benefit of neoadjuvant pembrolizumab or atezolizumab, respectively, with chemotherapy versus chemotherapy alone for TNBC
• Current nonresearch role, if any, of neoadjuvant immune checkpoint inhibition for patients with TNBC
• Long-term efficacy and safety findings from the Phase III IMpassion130 trial evaluating atezolizumab/nab paclitaxel as first-line therapy for metastatic TNBC (mTNBC)
• Primary results from the Phase III IMpassion131 study of first-line paclitaxel with or without atezolizumab for mTNBC; recent FDA alert regarding efficacy and safety concerns with this combination
• Key efficacy and safety findings supporting the recent FDA approval of pembrolizumab in combination with chemotherapy for patients with previously untreated PD-L1-positive mTNBC (KEYNOTE-355 trial); effect of chemotherapy partner and previous chemotherapy exposure on outcomes
• FDA approvals of atezolizumab/nab paclitaxel and pembrolizumab/chemotherapy for PD-L1-positive mTNBC; optimal integration into practice
• Mechanism of action, available data and recent FDA approval of sacituzumab govitecan; biomarker findings from the confirmatory Phase III ASCENT study and optimal integration into mTNBC management algorithms
• Other promising novel agents and strategies under investigation for TNBC (eg, ladiratuzumab vedotin, datopotamab deruxtecan)

Module 4: Available Data with and Practical Integration of PARP Inhibition in the Care of Patients with mBC

• Phase III data sets supporting the FDA approvals of olaparib and talazoparib for patients with mBC and germline BRCA mutations; optimal integration into management algorithms
• Key findings from the Phase II TBCRC 048 study of olaparib monotherapy for patients with mBC with germline or somatic mutations in DDR (DNA damage response) pathway genes beyond germline BRCA1/2 mutations
• Recommended genetic testing algorithms and patient selection for PARP inhibition in routine general medical oncology practice
• Available efficacy and safety results from studies combining veliparib with platinum-based chemotherapy (eg, BROCADE 3, SWOG-S1416) for mBC
• Biologic rationale for the investigation of PARP inhibitors combined with immune checkpoint inhibitors; early results and ongoing studies (eg, KEYLYNK-009)
• Available data with and ongoing investigation of PARP inhibition in the adjuvant and neoadjuvant settings

Target Audience
This program is intended for medical oncologists, hematology-oncology fellows and other allied healthcare professionals involved in the treatment of breast cancer.

Learning Objectives

• Evaluate the results of genomic assays and other patient- and treatment-related factors to personalize adjuvant systemic therapy for individuals with newly diagnosed ER-positive, HER2-negative breast cancer.
• Individualize the selection and sequence of systemic therapy for patients with ER-positive metastatic breast cancer, considering age, menopausal status, prior treatment course, comorbidities, symptomatology and extent and sites of disease.
• Develop an evidence-based algorithm for the treatment of advanced hormone receptor-positive pre- and postmenopausal breast cancer, incorporating endocrine therapy and biologic and chemotherapeutic agents.
• Understand the biologic rationale for and available data with CDK4/6 inhibitors for localized ER-positive, HER2-negative breast cancer, and assess the potential therapeutic role of these agents in this setting.
• Recognize the FDA approval of and published efficacy and safety data with the PI3 kinase inhibitor alpelisib in combination with fulvestrant for patients with advanced HER2-negative breast cancer harboring a PIK3CA mutation, and consider the diagnostic and therapeutic implications of these findings for nonresearch care.
• Appraise available data with (neo)adjuvant PARP inhibitors for patients with BRCA mutations and HER2-negative breast cancer, and consider the current and potential role of these agents in clinical decision-making.
• Review published research evidence for the benefit of adding an immune checkpoint inhibitor to neoadjuvant chemotherapy for patients with triple-negative breast cancer, and use this information to make treatment recommendations.
• Appreciate recent FDA approvals of and ongoing clinical research evaluating novel agents and strategies for ER-positive or triple-negative breast cancer, and counsel patients regarding protocol and nonresearch treatment recommendations.

CME Credit Form
CME and ABIM MOC credit form links will be emailed to each participant within 5 days of the activity.

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 live activity for a maximum of 1 AMA PRA Category 1 Credit^TM. 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, enables the participant to earn up to 1 Medical Knowledge MOC point 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, this program has 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. For those clinicians wishing to receive ABIM MOC credit for attending, you will receive an email after the event with instructions.

Disclosure Policy
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 — Dr Goetz has no relevant conflicts of interest to disclose. The following faculty reported relevant conflicts of interest, which have been mitigated through a conflict of interest mitigation process:

Dr Rugo — Consulting Agreement: Samsung Bioepis (limited consulting); Contracted Research: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Eisai Inc, Genentech, a member of the Roche Group, Immunomedics Inc, Lilly, MacroGenics Inc, Merck, Novartis, OBI Pharma Inc, Odonate Therapeutics, Pfizer Inc, Seagen Inc, Sermonix Pharmaceuticals; Honoraria: Mylan, Puma Biotechnology Inc; Travel: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, MacroGenics Inc, Merck, Mylan, Novartis, Pfizer Inc. Dr Telli — Advisory Committee: AbbVie Inc, Blueprint Medicines, Celgene Corporation, Chinook Therapeutics, Daiichi Sankyo Inc, Immunomedics Inc, Lilly, Natera Inc, OncoSec Medical, Pfizer Inc; Consulting Agreements: Genentech, a member of the Roche Group, Guardant Health, Merck; Contracted Research: AbbVie Inc, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Biothera Pharmaceuticals Inc, Calithera Biosciences, EMD Serono Inc, Genentech, a member of the Roche Group, Merck, OncoSec Medical, Pfizer Inc, PharmaMar, Tesaro, A GSK Company, Vertex Pharmaceuticals Incorporated; Data and Safety Monitoring Board/Committee: G1 Therapeutics, Immunomedics 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: AbbVie Inc, Adaptive Biotechnologies Corporation, Agios Pharmaceuticals Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol-Myers Squibb Company, Celgene Corporation, Clovis Oncology, Daiichi Sankyo Inc, Eisai Inc, Epizyme Inc, Exact Sciences Inc, Exelixis Inc, Five Prime Therapeutics Inc, Foundation Medicine, Genentech, a member of the Roche Group, Gilead Sciences Inc, GlaxoSmithKline, Grail Inc, Halozyme Inc, Helsinn Healthcare SA, 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, Lilly, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Merck, Novartis, Novocure Inc, Oncopeptides, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Sanofi Genzyme, Seagen Inc, Sumitomo Dainippon Pharma Oncology Inc, Taiho Oncology Inc, Takeda Oncology, Tesaro, A GSK Company, TG Therapeutics Inc, Turning Point Therapeutics Inc and Verastem Inc.

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.

Supporters
This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Exact Sciences Inc, Lilly, Merck, Novartis, Puma Biotechnology Inc and Seagen Inc.