Methodologies for HER2-Low and Ultralow IHC: A Guided Laboratory Case Walk-through for Pathologists

Statement of Need

Accurately distinguishing HER2-low and ultralow expression in metastatic breast cancer (mBC) is critical, yet it presents unique challenges for pathologists. Traditional binary HER2 classifications no longer meet clinical needs, as the availability of antibody-drug conjugates (ADCs) now depend on more precise interpretation of immunohistochemistry (IHC) results. Inconsistencies in testing and reporting, particularly around descriptive language and clinically actionable terminology, can create barriers to optimal treatment selection and patient outcomes. This program is designed to provide expert perspectives to support the consistent application of nuanced HER2 scoring methodologies and the clear communication of results to the multidisciplinary care team.

In the third activity of this EfficientCME webcast series, faculty guide learners through a step-by-step case discussion that mirrors real-world practice. Faculty demonstrate how to apply the latest IHC scoring strategies to distinguish HER2-low and ultralow disease, and model best practices for reporting results in ways that directly support therapeutic decision-making.

Learning Objectives

At the conclusion of this activity, learners will be able to better:

Apply the most up-to-date IHC scoring methodology to accurately determine HER2 status (e.g. low/ultralow vs. negative) in primary or metastatic BC specimens based on staining intensity, proportion, location, completeness, and percentage of tumor cells stained
Implement best practices for reporting HER2 IHC scoring results to the multidisciplinary BC care team using clinically relevant quantitative and qualitative terminology — including detailed descriptions of staining patterns — to help guide therapeutic selection

Financial Support

Supported by educational grants from AstraZeneca Pharmaceuticals and Daiichi Sankyo, Inc.

Target Audience

Medical oncologists and pathologists

Credit Information

Jointly Accredited Provider

In support of improving patient care, this activity has been planned and implemented by CME Outfitters, LLC, and EfficientCME. 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.

Physicians (ACCME) 0.5

CME Outfitters, LLC, designates this enduring material for a maximum of 0.50 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Note to Nurse Practitioners: Nurse practitioners can apply for AMA PRA Category 1 Credit™ through the American Academy of Nurse Practitioners (AANP). AANP will accept AMA PRA Category 1 Credit™ from Jointly Accredited Organizations. Nurse practitioners can also apply for credit through their state boards.

Physician Associates (AAPA) 0.5

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 0.50 AAPA Category 1 CME credits. Approval is valid until 12/17/2026. PAs should only claim credit commensurate with the extent of their participation.

ABIM MOC 0.5

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 0.50 MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

ABPath

This activity meets the requirements and has been registered to offer credit for the American Board of Pathology for lifelong learning (CME.)

Canadian Physicians who wish to claim credit must select both ACCME and MOC certificates.

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. The following information is for participant information only. It is not assumed that these relationships will have a negative impact on the presentations.

Jane L. Meisel, MD, FASCO, reports the following financial relationships:

Advisory Board: AstraZeneca; Olema Oncology; Pfizer Inc.; and Sermonix Pharmaceuticals

Consultant: AstraZeneca; Genentech, Inc.; GSK; Novartis Pharmaceuticals Corporation; Olema Oncology; Pfizer Inc.; and Sermonix Pharmaceuticals

Research Support: AstraZeneca; Olema Oncology; and Sermonix Pharmaceuticals

Xiaoxian (Bill) Li, MD, PhD, reports the following financial relationships:

Advisory Board: Lilly and Roche

Consultant: Cancer Expert Now, LLC

Research Support: Champions Oncology, Inc.

The following individuals have no financial relationships to disclose:

Alaa Bawaneh, MD, PhD (Peer Reviewer)
Mary Gleason, PhD, CHCP (Planning Committee)
Sarah Hertich (Planning Committee)
Scott J. Hershman, MD, FACEHP, CHCP (Planning Committee)
Sandra Caballero, PharmD (Planning Committee)
Sharon Tordoff (Planning Committee)

*All identified conflicts of interest have been mitigated.

Unlabeled Use Disclosure
Faculty of this CME/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. CME Outfitters, LLC, the faculty, planners, and reviewers do not endorse the use of any product outside of the FDA labeled indications. Medical professionals should not utilize the procedures, products, or diagnosis techniques discussed during this activity without evaluation of their patient for contraindications or dangers of use.

Obtaining Credit

Post-tests, credit request forms, and activity evaluations must be completed online (requires free account activation), and participants can print their certificate or statement of credit immediately (70% pass rate required). This website supports all browsers except Internet Explorer for Mac.

Questions about this activity?

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

WCV-115-121725-90

Methodologies for HER2-Low and Ultralow IHC: A Guided Laboratory Case Walk-through for Pathologists

Faculty

Statement of Need

Learning Objectives

Financial Support

Target Audience