OncologyConsults



Novel Combination Therapies in HR+/HER2- Metastatic Breast Cancer:
New Standards of Care?

Presented by the Johns Hopkins University School of Medicine and the Institute for Johns Hopkins Nursing

Supported by an educational grant from Pfizer Inc.

OVERVIEW
Historically, the cornerstone of the treatment of patients with hormone receptor positive (HR+), human epidermal growth factor receptor-2 negative (HER2-) metastatic breast cancer has been endocrine therapy. Unfortunately, the development of endocrine resistance can limit the efficacy of this approach. The addition of targeted agents to endocrine therapy can be effective in overcoming endocrine resistance. Recent data have shown that the combination of novel agents targeting cyclin-dependent kinases 4 and 6 (CDK4/6) with endocrine therapy regimens has led to recent improvements in progression free survival with good treatment tolerance. In this activity, we review recent clinical trials that evaluate targeted agents in combination with endocrine therapy for first-line and later line treatment of patients with HR+, HER2- metastatic breast cancer.

GOAL
The goal of this activity is to understand the available data regarding the combination of endocrine therapy and targeted therapy for the treatment of patients with HR+, HER2- metastatic breast cancer.

TARGET AUDIENCE
This activity is intended for oncology healthcare providers (oncologists, oncology nurses, and oncology physician assistants) who care for patients with metastatic breast cancer. No prerequisites required.

LEARNING OBJECTIVES
After participating in this activity, the participant will demonstrate the ability to:
  • IDENTIFY the available regimens combining endocrine therapy and novel agents for the treatment of HR+, HER2- metastatic breast cancer.
  • DIFFERENTIATE the situations in which each combination regimen has been evaluated and approved based on the latest clinical trial data.
  • INCORPORATE combination therapy options with appropriate monitoring for toxicities into treatment plans for HR+, HER2- metastatic breast cancer based on current evidence.
The Johns Hopkins University School of Medicine and the Institute for Johns Hopkins Nursing take responsibility for the content, quality, and scientific integrity of this CME/CNE activity.

CE INFORMATION
Accreditation Statements
accme_logoThis activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of the Johns Hopkins University School of Medicine and the Institute for Johns Hopkins Nursing. The Johns Hopkins University School of Medicine is accredited by the ACCME to provide continuing medical education for physicians.

The Institute for Johns Hopkins Nursing is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.

Credit Designation Statements — The Johns Hopkins University School of Medicine designates this enduring material for a maximum of 1.0 AMA PRA Category 1 CreditTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

This 1.0 contact hour educational activity is provided by the Institute for Johns Hopkins Nursing. Claim only those contact hours actually spent in the activity. Statements will be awarded for this educational activity until July 30, 2019.

The estimated time to complete this activity: 60 minutes.

Release date: July 31, 2018    Expiration date: July 30, 2019

Policy On Speaker and Provider Disclosure
It is the policy of the Johns Hopkins University School of Medicine and the Institute for Johns Hopkins Nursing that the speaker and provider globally disclose conflicts of interest. The Johns Hopkins University School of Medicine OCME has established policies that will identify and resolve conflicts of interest prior to this educational activity. Detailed disclosure will be made prior to presentation of the education.

Full Disclosure Policy Affecting CME Activities
As a provider approved by the Accreditation Council for Continuing Medical Education (ACCME), Johns Hopkins University School of Medicine Office of Continuing Medical Education (OCME) requires attested and signed global disclosure of the existence of all financial interests or relationships with commercial interest from any individual in a position to control the content of a CME activity sponsored by OCME. The following relationships have been reported for this activity:

Planner Disclosures
Dr. Ettinger reports serving as a principal investigator for Golden Biotechnology Corp and serving as a consultant for AbbVie Inc, BeyondSpring Pharmaceuticals, Inc, Boehringer Ingelheim Vetmedica, Inc, Bristol-Myers Squibb Company/Sanofi-Aventis US LLC, Eli Lilly and Company, Guardant Health Inc., and Genentech Inc.

Dr Nunes reports receiving a consulting fee from Bristol-Myers Squibb Company.

Dr Smith reports serving as an investigator for Pfizer Inc., and a co-investigator for UnderArmour, and reports that her spouse holds stock in Abbott Laboratories and AbbVie Inc.


No other planners or faculty have indicated that they have any financial interests or relationships with a commercial entity.

Note: Grants to investigators at The Johns Hopkins University are negotiated and administered by the institution that receives the grants, typically through the Office of Research Administration. Individual investigators who participate in the sponsored project(s) are not directly compensated by the sponsor, but may receive salary or other support from the institution to support their effort on the project(s).

FACULTY
Johns Hopkins University School of Medicine Chair and Planner
David S. Ettinger, MD

Alex Grass Professor in Oncology
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland

Participating Faculty
Karen Lisa Smith, MD, MPH

Assistant Professor of Oncology
Breast and Ovarian Cancer Program
Sibley Memorial Hospital
Washington, DC

Maria Raquel Nunes, MD
Assistant Professor of Oncology
Breast and Ovarian Cancer Program
Sibley Memorial Hospital
Washington, DC

Nurse Planner
Rebecca Barshick, RN, MSN

Nurse Educator
The Institute for Johns Hopkins Nursing
Baltimore, Maryland

Nurse Reviewer
MiKaela Olsen APRN-CNS, MS, AOCNS, FAAN

Oncology and Hematology Clinical Nurse Specialist
Ambulatory Oncology
Sidney Kimmel Comprehensive Cancer Center
Johns Hopkins University School of Medicine
Baltimore, Maryland

Peer Reviewer
Bradley Reames, MD, MS

Oncology Fellowship
Department of Surgery
Johns Hopkins Hospital
Baltimore, Maryland

Off-Label Product Discussion
The following speakers have disclosed that their presentation will reference unlabeled/unapproved uses of drugs or products:
Dr Nunes and Dr Smith – Discussion of everolimus in combination with tamoxifen and fulvestrant but only approved in combination with exemestane.

Non-Endorsement of Products
The Institute for Johns Hopkins Nursing and the American Nurses Credentialing Center do not endorse the use of any commercial products discussed or displayed in conjunction with this educational activity.

DISCLAIMER
The opinions and recommendations expressed by faculty and other experts whose input is included in this activity are their own. This activity is produced for educational purposes only. Use of Johns Hopkins University School of Medicine name implies review of educational format, design, and approach. Please review the complete prescribing information of specific drugs or combinations of drugs, including indications, contraindications, warnings, and adverse effects before administering pharmacologic therapy to patients.

CONFIDENTIALITY DISCLAIMER FOR CME ACTIVITY PARTICIPANT
I certify that I am participating in this Johns Hopkins University School of Medicine activity for CME-accredited training and/or educational purposes.

I understand that while I am participating in this capacity, I may be exposed to "protected health information," as that term is defined and used in Hopkins policies and in the federal HIPAA privacy regulations (the “Privacy Regulations”). Protected health information is information about a person's health or treatment that identifies the person.

I pledge and agree to use and disclose any of this protected health information only for the training and/or educational purposes of my visit and to keep the information confidential. I agree not to post or discuss this protected health information, including pictures and/or videos, on any social media site (eg, Facebook, Twitter, etc.), in any electronic messaging program or through any portable electronic device.

I understand that I may direct to the Johns Hopkins Privacy Officer any questions I have about my obligations under this Confidentiality Pledge or under any of the Hopkins policies and procedures and applicable laws and regulations related to confidentiality. The contact information is: Johns Hopkins Privacy Officer, telephone: 410-735-6509, e-mail: HIPAA@jhmi.edu.

“The Office of Continuing Medical Education at the Johns Hopkins University School of Medicine, as sponsor of this activity, has relayed information with the CME attendees/participants and certify that the visitor is here for training, education and/or observation purposes only.”

For CME questions, please contact the CME Office at 410-955-2959 or e-mail cmenet@jhmi.edu.
Johns Hopkins University School of Medicine
Office of Continuing Medical Education
720 Rutland Avenue/ Turner 20
Baltimore, Maryland 21205-2195
Reviewed & Approved by: General Counsel, Johns Hopkins Medicine (4/1/03) (Updated 4/09 and 3/14)

HARDWARE & SOFTWARE REQUIREMENTS
Pentium 800 processor or greater, Windows 98/NT/200/XP or Mac OS 9/X or later, Microsoft Internet Explorer, Safari, Firefox, Windows Media Player 9.0 or later Flash player, 128 MB of RAM Monitor settings: High color at 800 x 600 pixels, Sound card and speakers, Adobe Acrobat Reader.

THE INSTITUTE FOR JOHNS HOPKINS NURSING MISSION STATEMENT
The mission of the Institute for Johns Hopkins Nursing is to share the innovations of Johns Hopkins Nursing in practice, education, and research—locally, nationally, and globally. Our goal in continuing nursing education is to bring you activities that reflect the expertise and creativity of Johns Hopkins Nursing. Our service values are quality, integrity, flexibility, and personal attentiveness. We appreciate your thoughts and welcome your concerns—please feel free to e-mail us: IJHN@.jhmi.edu.

ACTIVITY INSTRUCTIONS
The following is an interactive case module designed to help you gauge your basic knowledge of the topic and then direct you to areas you may need to focus on. It consists of 3 sections: an unaccredited pre-test, an interactive case study, and a CME/CNE post-test and evaluation. All 3 sections must be completed to receive CME/CNE credit. A certificate of participation will be available online immediately following successful completion of the activity.

Preassessment

Novel Combination Therapies in HR+/HER2- Metastatic Breast Cancer:
New Standards of Care?

Karen Lisa Smith, MD, MPH, and Maria Raquel Nunes, MD

Postassessment and Evaluation

This activity was developed in collaboration with ASiM.


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