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Optimal Utilization of Ki67 Testing in HR-Positive/HER2-Negative Early Breast Cancer: Education and Resources for the Oncology and Pathology Healthcare Teams

In this on-demand webcast from a live webinar, Joyce O’Shaughnessy, MD, reviews the current data supporting the utilization of Ki67 testing in HR-positive/HER2-negative early breast cancer, including strategies to promote adherence to oral CDK4/6 inhibitors.

Pharmacists: 1.00 contact hour (0.1 CEUs)

Physicians: Maximum of 1.00 AMA PRA Category 1 Credit

Nurses: 1.00 Nursing contact hour

Released: May 11, 2022

Expiration: May 10, 2023

No longer available for credit.



Sara M. Tolaney

Sara M. Tolaney, MD, MPH

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

Provided by

Provided by a partnership between the American Society for Clinical Pathology and Clinical Care Options, LLC.
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This activity is supported by an educational grant from


Target Audience

This program is intended for oncologists, pathologists, histotechologists, pharmacists, oncology nurses, and other healthcare professionals who care for patients with breast cancer.

Learning Objectives

Upon completion of this activity, participants should be able to:
  • Incorporate the evidence on the current use of Ki67 as a predictive and prognostic biomarker into clinical practice
  • Evaluate the clinical validity, utility, and differences among Ki67 assessment techniques
  • Integrate best practices for Ki67 testing methodology, standardization, and reporting
  • Identify patients with high-risk features who may benefit from the addition of CDK4/6 inhibitor therapy to endocrine therapy in the adjuvant setting
  • Foster collaborative discussions and workflows among oncologists, pathologists, and the multidisciplinary team on recent clinical evidence to guide personalized treatment planning for HR-positive/HER2-negative early breast cancer
  • Identify patients with HR-positive/HER2-negative early breast cancer that expresses Ki67 who may be eligible for ongoing clinical trials 


Clinical Care Options, LLC (CCO) requires instructors, planners, managers, and other individuals who are in a position to control the content of this activity to disclose all financial conflicts of interest (COI) they may have with ineligible companies. All relevant COI are thoroughly vetted and mitigated according to CCO policy. CCO is committed to providing its learners with high-quality CME/CE activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of an ineligible company.

The faculty reported the following relevant financial relationships or relationships to products or devices they have with ineligible companies related to the content of this educational activity:

Program Director Disclosure

Program Director

Sara M. Tolaney, MD, MPH

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

Sara Tolaney, MD, MPH, has disclosed that she has received funds for research support (paid to her institution) from AstraZeneca, Bristol-Myers Squibb, Cyclacel, Eisai, Exelixis, Genentech, Immunomedics/Gilead, Lilly, Merck, Nanostring, Nektar, Novartis, Odonate, Pfizer, Sanofi, and Seattle Genetics and consulting fees from 4D Pharma, AstraZeneca, Athenex, BeyondSpring, Bristol-Myers Squibb, Chugai, CytomX, Daiichi Sankyo, Eisai, Ellipses Pharma, Genentech, Immunomedics/Gilead, Infinity, Lilly, Mersana, Novartis, OncoPep, OncoSec, OncXerna, Pfizer, Puma, Sanofi, Samsung Bioepsis, Seattle Genetics, Zymeworks, and Zentalis.

Staff Disclosure


Kelly Brandt, PharmD

Kelly Brandt, PharmD, BCOP, BCPS, has no relevant conflicts of interest to report.

Kayla Douglas, PharmD

Director of Pharmacy
Mississippi Center for Advanced Medicine
Madison, Mississippi

Kristi Kay Orbaugh, RN, MSN, RNP, AOCN has received speaker fees from BMS, Lilly, Sanofi, Regeneron, Gilead, Morphosys, Pfizer, AstraZeneca and DSI.

Gordon Kelley,

Clinical Editor
Clinical Care Options, LLC

Gordon Kelley has no relevant conflicts of interest to report.

Krista Marcello,

Associate Managing Editor

Krista Marcello has no relevant conflicts of interest to report.

Kemi Obajimi, PhD

Scientific Director

Kemi Obajimi, PhD, has no relevant conflicts of interest to report.

Kevin Obholz, PhD

Editorial Director, Hematology/Oncology

Kevin Obholz, PhD, has no relevant conflicts of interest to report.

Timothy A. Quill, PhD

Senior Managing Editor

Timothy A. Quill, PhD, has no relevant conflicts of interest to report.

Kristen Rosenthal, PhD

Clinical Editor

Kristen Rosenthal, PhD, has no relevant conflicts of interest to report.

Instructions for Credit


Joint Accreditation Statement

In support of improving patient care, Clinical Care Options, LLC (CCO) 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.

Physician Continuing Medical Education

Credit Designation

CCO designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Credit Designation

The maximum number of hours awarded for this Continuing Nursing Education activity is 1.0 contact hour.

Credit Designation

CCO designates this continuing education activity for 1.0 contact hour (0.1 CEUs) of the Accreditation Council for Pharmacy Education. Universal Activity Number - JA4008176-0000-22-135-H01-P.

Type of Activity: Application

Upon successfully completing the post-test with a score of 65% or better and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 60 days.

Disclosure of Unlabeled Use

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.


Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

Additional Information

Participation in this self-study activity should be completed in approximately 1 hours. To successfully complete this activity and receive credit, participants must follow these steps during the period from May 11, 2022, through May 10, 2023:

1. Register online at
2. Read the target audience, learning objectives, and faculty disclosures.
3. Study the educational activity online or printed out.
4. Submit answers to the posttest questions and evaluation questions online.

You must receive a test score of at least 65% and respond to all evaluation questions to receive a certificate. After submitting the evaluation, you may access your online certificate by selecting the certificate link on the posttest confirmation page. Records of all CME/CE activities completed can be found on the "CME/CE Manager" page. There are no costs/fees for this activity.

Program Medium

This program has been made available online.


The goal of this educational curriculum is to improve the knowledge, competence, and performance of learners to optimally assess patients with HR-positive/HER2-negative early breast cancer for Ki67 and accurately report, interpret, and apply results of the testing to optimal therapy selection.