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This activity is part of the Multidisciplinary Breast Pathology (MBP) learning series.

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Intended Audience
This Multidisciplinary Breast Pathology (MBP) activity is intended for pathologists looking for information on the 2018 and 2023 HER2 Focused Updates.

Note: This activity was reviewed and updated prior to the June 2026 updates to the CAP Cancer Protocols. The updated protocols can be reviewed/downloaded here or reviewed on www.cap.org (search for CAP Cancer Protocols).

Rereleased Activity
This activity was originally released as 2018 HER2 Focused Update and was available between June 29, 2023, and June 29, 2026. The content was reviewed in March 2026.

Description
In 2018, the American Society of Clinical Oncology and the CAP developed a focused update on human epidermal growth factor receptor 2 (HER2) testing in breast cancer. The focused update endorses the 2013 HER2 testing guidelines while addressing outstanding questions related to HER2 testing. The guidelines were updated again in 2023, reaffirming the 2018 ASCO/CAP guidelines for HER2 testing and acknowledging emerging evidence supporting the efficacy of T-DXd in this subset of HER2-negative breast cancers. The 2023 Update also introduces a new HER2 testing report comment to underscore the clinical relevance of distinguishing IHC 1+ from IHC 0 results, along with best practice recommendations in identifying these subtle differences.

This activity addresses six clinical questions raised since the 2013 update and includes case studies that illustrate the practical application of what has been proposed in this update. A new clinical question was added to the course to reflect the 2023 HER2 Focused Update.

Objectives
After completing this activity, you should be able to:

1. Describe the purpose of the 2018 HER2 Focused Update.
2. State the most appropriate definition for IHC2+ (IHC equivocal).
3. Clarify if HER2 testing must be repeated on a surgical specimen if initially negative test on core biopsy.
4. Explain if invasive cancers with a HER2/chromosome enumeration probe 17 (CEP17) ratio of ≥2 but an average HER2 copy number of <4.0 signals per cell should be considered ISH positive.
5. Explain if invasive cancers with an average HER2 copy number of ≥6.0 signals per cell but a HER2/CEP17 ratio of <2.0 should be considered ISH positive.
6. Explain the appropriate diagnostic workup for invasive cancers with an average HER2 copy number ≥4.0 but <6.0 signals per cell and a HER2/CEP17 ratio <2.0 and initially deemed to have an equivocal HER2 ISH test result.
7. Describe the clinical relevance of distinguishing IHC 1+ from IHC 0 results and best practices for identifying the subtle differences.

Authors/Faculty
Monisha Bhanote, MD, FCAP
David G. Hicks, MD, FCAP
Huina Zhang, MD, PhD, FCAP

CME Information
Accreditation: The College of American Pathologists (CAP) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CME Category 1: The CAP designates this educational activity for a maximum of 1.25 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Payment Information
To pay with a check, print a copy of this page and send it with your check to the address below. You will be notified when your payment has been processed and you have been registered into the activity.

College of American Pathologists
CAP Learning
325 Waukegan Road
Northfield, IL 60093-2750

Refund Policy
Refunds will be handled on an exception basis. Please submit your request to the CAP in writing via email at [email protected] or fax at 847-832-8006.

Technical Requirements
Pop-up blockers must be turned off.

The CAP recognizes that some Veteran’s Administration, US Government, and military participants may have difficulty accessing the online activity. If you experience difficulty or have any questions, please contact a representative of the Customer Contact Center at 800-323-4040 option 1 or [email protected].

Availability
This activity and evaluation are available June 30, 2026 - June 29, 2029, at 11:59 PM (CT). Upon completion of the activity your credit will be awarded. Your certificate may be downloaded from your Transcript.

CC: MBPHER206W.2026

Key Words: N/A

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