Decoding Clinical Trial Data and Real-World Evidence in mBC, with a Focus on Individualized Care

Faculty

Sara A. Hurvitz, MD, FACP
Professor, Division of Hematology-Oncology
Department of Medicine, David Geffen School of Medicine at UCLA
Co-Director, Santa Monica-UCLA Outpatient Oncology Practice
Director, Breast Oncology Program, Division of Hematology-Oncology
University of California, Los Angeles
Los Angeles, CA
Sara A. Hurvitz, MD, FACP

Sara A. Hurvitz, MD, is a Professor of Medicine at the University of California, Los Angeles (UCLA), Co-Director of the Santa Monica-UCLA Outpatient Oncology Practice, Medical Director of the Clinical Research Unit of the Jonsson Comprehensive Cancer Center at UCLA, and Director of Breast Oncology. Dr. Hurvitz earned her MD from the University of Southern California. She served her internship and residency at UCLA, was Chief Resident of internal medicine, and completed a hematology-oncology fellowship at UCLA in 2006. Dr. Hurvitz is board certified in internal medicine, hematology, and medical oncology.

Dr. Hurvitz has received numerous awards over the past few years, among them the Marni Levine Memorial Breast Cancer Research Award from 2008 through 2015. She has an active clinical practice specializing in the treatment of women with breast cancer. She is involved in designing, implementing, and leading multiple national and international clinical trials testing new targeted therapies, and leads the preclinical evaluation of novel breast cancer targets in the Translation Oncology Research Laboratory at UCLA.

Jamil Rivers
Metastatic Breast Cancer Thriver
Founder and CEO, The Chrysalis Initiative
Board President, METAvivor Research and Support, Inc.
Annapolis, MD
Jamil Rivers

In 2018, Jamil was diagnosed with breast cancer after she had a cold and lingering cough brought her in to see her primary doctor. Her doctor initially prescribed an antibiotic, but after a few weeks she returned as she wasn’t feeling better. A pinch in her side prompted her to ask for an ultrasound, as Jamil has a family history of gallbladder and appendix issues. During the ultrasound, the doctors discovered lesions on her liver. After a mammogram and breast biopsy, they determined Jamil had Stage IV de novo metastatic breast cancer that had spread all over her body except for her brain and her spine.

At the time of her diagnosis, Jamil was 39 years old with three sons at home, her youngest was 5 years old. Her husband is disabled after his experience with colon cancer and a liver transplant, so it was important that Jamil continue to be her family’s caregiver through her treatment. Jamil underwent one year of chemotherapy without taking time off from work or disclosing her breast cancer diagnosis. In addition to chemo, Jamil underwent an oophorectomy and after one year she had no evidence of disease.

Jamil is the founder and CEO of The Chrysalis Initiative. Jamil founded The Chrysalis Initiative which provides guidance on how to thrive with breast cancer. Jamil’s extensive research to understand breast cancer and comprehensive breast cancer care became the foundation for The Chrysalis Initiative. Mentoring and coaching 50 women led her to creating a curriculum for comprehensive cancer care specifically for Black women. Today, The Chrysalis Initiative offers a variety of services including One-on-One Coaching, Provider Equity Assessments, Training & Education, and Student Training Programs.

Jamil is also Board President of METAvivor Research and Support, Inc. She is a Young Advocate Alum, Board Member of Living Beyond Breast Cancer, and Advisory Chair of the <i>Knowledge is Power: Understanding Black Breast Cancer</i> series. She is a policy and science advocate with Susan G. Komen.

In addition, Jamil is a member and patient advisor of the Metastatic Breast Cancer Alliance and is a Project LEAD graduate and proposal reviewer for the Breast Cancer Research program with the Department of Defense. She has been featured in People magazine, the Philadelphia Inquirer the Philadelphia Tribune, national campaigns for Anthropologie, Novartis, Pfizer, and Cancer and Careers, as well as on CBS News and Good Morning America.

Sara Tolaney, MD, MPH
Chief, Division of Breast Oncology, Dana-Farber Cancer Institute
Associate Director, Susan F. Smith Center for Women's Cancers
Senior Physician, Dana-Farber Cancer Institute
Associate Professor of Medicine, Harvard Medical School
Boston, MA
Sara Tolaney, MD, MPH

Sara Tolaney, MD, MPH, is the Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute, and is internationally recognized for her research and education leadership in breast cancer. She also serves as Associate Director of the Susan F. Smith Center for Women’s Cancers and is a Senior Physician at Dana-Farber Cancer Institute and Associate Professor of Medicine at Harvard Medical School.

Dr. Tolaney received her undergraduate degree from Princeton University and her medical degree from UC San Francisco. She subsequently completed her residency in Internal Medicine at Johns Hopkins University, and fellowships in hematology and medical oncology at Dana-Farber Cancer Institute. She obtained her Masters in Public Health from Harvard School of Public Health.

Her research focuses on the development of novel therapies in the treatment of breast cancer and developing more effective and less toxic treatment approaches. Her work has demonstrated that a relatively low-risk regimen is beneficial in women with early stage node-negative HER2-positive cancers, and this work has been incorporated into national and international guidelines. She has developed several follow-up studies looking at novel approaches to early stage HER2-positive disease and has also played a significant role in development of CDK 4/6 inhibitors, antibody drug conjugates, and immunotherapy in breast cancer. She currently chairs several registration studies in these areas and also leads many investigator-initiated trials.  She is the author of over 150 peer-reviewed publications with manuscripts included in many prestigious journals such as The New England Journal of Medicine, Lancet Oncology, the Journal of Clinical Oncology, and JAMA Oncology.

 

Statement of Need

Despite promising, data-driven treatment recommendations for breast cancer posed by the National Comprehensive Cancer Network (NCCN), gaps in patient and provider education on available therapies remain. It is crucial for clinicians and patients to be wholly informed of treatment options as well as the similarities and differences between randomized clinical trials and real-world data, in order to lay the groundwork for shared decision making. By increasing provider and patient knowledge and thus enhancing the shared decision-making process, greater concordance between treatments offered and the guidelines can occur, leading to optimal patient outcomes.

In this 45-minute interactive CME Outfitters Snack, a diverse panel of expert faculty will discuss the evolving treatment landscape of metastatic breast cancer and how to integrate the latest clinical evidence, real world evidence, and treatment guideline recommendations to foster patient health literacy, shared-decision making, and individualized outcomes.

Learning Objectives

  • Utilize guideline treatment recommendations in the care of patients with HR+/HER2- mBC.
  • Evaluate safety and efficacy data from RCTs and RWE bearing on the treatment of patients with HR+/HER2- mBC.
  • Integrate efficacy and safety RWE for CDK4/6is in patient education and counseling for patients with HR+/HER2-mBC.

Financial Support

Supported by an educational grant from Pfizer Inc.

Target Audience

Physicians, nurse practitioners (NPs), physician associates (PAs), nurses, pharmacists, or other healthcare professionals involved in the care of patients with HR+/HER2- mBC. Patients and caregivers may also benefit from participating in this activity.

Credit Information

Jointly Accredited Provider

In support of improving patient care, CME Outfitters, LLC, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.

Interprofessional (IPCE) 0.75

This activity was planned by and for the healthcare team, and learners will receive 0.75 Interprofessional Continuing Education (IPCE) Credit for learning and change.

Physicians (ACCME) 0.75

CME Outfitters, LLC, is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. CME Outfitters, LLC, designates this enduring activity for a maximum of .75 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Nurses (ANCC) 0.75

This activity is designated for 0.75 contact hour. Nurse practitioners can apply for AMA PRA Category 1 Credit(s)™ through the American Academy of Nurse Practitioners (AANP). AANP will accept AMA PRA Category 1 Credit(s)™ from Jointly Accredited Organizations. Nurse practitioners can also apply for credit through their state boards.

Note for California Nurses

This continuing nursing education activity was approved by the California Board of Registered Nursing. CME Outfitters, LLC’s provider number is CEP15510.

Pharmacists (ACPE) 0.75

This application-based activity is approved for 0.75 contact hour (0.075 CEUs) of continuing pharmacy credit.
Activity UAN: JA0007185-0000-23-017-H01-P

Physician Assistants (AAPA): 0.75

CME Outfitters, LLC, has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. This activity is designated for 0.75 AAPA Category 1 CME credits. Approval is valid until expiration date listed above. PAs should only claim credit commensurate with the extent of their participation.

ABIM MOC 0.75

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 0.75 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.

Royal College MOC

Through an agreement between the Accreditation Council for Continuing Medical Education and the Royal College of Physicians and Surgeons of Canada, medical practitioners participating in the Royal College MOC Program may record completion of accredited activities registered under the ACCME’s “CME in Support of MOC” program in Section 3 of the Royal College’s MOC Program.

MIPS Improvement Activity

Completion of this accredited CME activity meets the expectations of an Accredited Safety or Quality Improvement Program (IA_PSPA_28) for the Merit-based Incentive Payment Program (MIPS). Clinicians should submit their improvement activities by attestation via the CMS Quality Payment Program website.

Disclosure Declaration

It is the policy of CME Outfitters, LLC, to ensure independence, balance, objectivity, and scientific rigor and integrity in all of their CE activities. Faculty must disclose to the participants any relationships with commercial companies whose products or devices may be mentioned in faculty presentations, or with the commercial supporter of this CE activity. CME Outfitters, LLC, has evaluated, identified, and mitigated any potential conflicts of interest through a rigorous content validation procedure, use of evidence-based data/research, and a multidisciplinary peer review process.

Dr. Hurvitz reports the following financial relationships:

Advisory Board: Ambrx; Amgen Inc.; Arvinas; AstraZeneca; Bayer AG; CytomX Therapeutics, Inc.; Daiichi-Sankyo, Inc.; Dantari; Dignitana; Eli Lilly and Company; G1-Therapeutics, Inc.; Genentech, Inc./Roche; Gilead Sciences, Inc.; Greenwich LifeSciences, Inc; GSK; Immunomedics; MacroGenics, Inc.; Novartis Pharmaceuticals Corporation; OBI Pharma; Orinove Inc.; Orum Therapeutics; Pfizer Inc.; Phoenix Molecular Designs; Pieris Pharmaceuticals, Inc.; Puma Biotechnology, Inc.; Radius Health, Inc.; Samumed; Sanofi; Seattle Genetics, Inc./Seagen Inc.; and Zymeworks Inc.


Ms. Rivers reports no financial relationships to disclose.


Dr. Tolaney reports the following financial relationships:

Consultant: 4D pharma plc; Aadi Biosciences; Arch Therapeutics, Inc.; AstraZeneca; Athenex, Inc.; Bayer; BeyondSpring Inc.; Blueprint Medicines Corporation; Bristol Myers Squibb Company; Certara, Inc.; Chugai Pharma USA, Inc.; CytomX Therapeutics, Inc.; Daiichi Sankyo, Inc.; Eisai Inc.; Eli Lilly and Company; Ellipses Pharma; Genentech, Inc./Roche; Gilead Sciences, Inc.; Infinity Therapeutics; Menarini/Stemline Therapeutics, Inc.; Merck & Co., Inc.; Mersana therapeutics; Myovant Sciences; Novartis Pharmaceuticals Corporation; Odonate Therapeutics, Inc.; OncoSec Medical Inc.; OncXerna Therapeutics, Inc.; Pfizer Inc.; Sanofi; Seattle Genetics; Inc.; Reveal Genomics; Umoja Biopharma; Zentalis Pharmaceuticals; Zetagen; and Zymeworks Inc.

Research Support (paid to institution):  AstraZeneca; Bristol Myers Squibb Company; Cyclacel Pharmaceuticals, Inc.; Eisai Inc.; Exelixis, Inc.; Genentech, Inc./Roche; Gilead Sciences, Inc.; Lilly; Merck & Co., Inc.; NanoString; Nektar; Novartis Pharmaceuticals Corporation; Pfizer Inc.; Sanofi and Seattle Genetics, Inc.


Disclosures were obtained from the CME Outfitters, LLC staff: No disclosures to report:

  • Elizabeth Naber, MSN, RN, CCRN-K, CNRN, TCRN (peer reviewer)
  • Thomas Mitchell (planning committee)
  • David Modrak, PhD (planning committee)
  • Susan H. Yarbrough, CHCP (planning committee)
  • Sandra Caballero, PharmD (planning committee)
  • Sharon Tordoff (planning committee)

Faculty of this CE activity may include discussions of products or devices that are not currently labeled for use by the FDA. The faculty have been informed of their responsibility to disclose to the audience if they will be discussing off-label or investigational uses (any uses not approved by the FDA) of products or devices.

Obtaining Credit

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Questions about this activity?

Call us at 877.CME.PROS (877.263.7767).

SN-184-042423-02

Decoding Clinical Trial Data and Real-World Evidence in mBC, with a Focus on Individualized Care
Event Date: 04/24/2023 at 4:00 am EST