Trial-by-gene · HER2-low (ERBB2)

Active clinical trials enrolling HER2-low breast cancer

Decision-support aid only — eligibility decisions must be confirmed against the actual trial protocol and the patient's medical record. Trial counts and statuses change daily; this page is for orientation, not adjudication.

HER2-low breast cancer became a treatable subgroup with DESTINY-Breast04. Active trials focus on (1) earlier-line T-DXd (DESTINY-Breast06 1L expansion), (2) HER2-ultralow (IHC 0 with membrane staining) trials extending the eligibility floor, (3) post-T-DXd resistance, and (4) ADC combination trials (T-DXd + checkpoint inhibitor, T-DXd + tucatinib).

See the HER2+ breast cheat sheet for full biology.

Browse the live listing

Search ClinicalTrials.gov for actively recruiting breast cancer trials with HER2-low or HER2-ultralow interventions.

Open ClinicalTrials.gov listing

Source: ClinicalTrials.gov, US National Library of Medicine. Trial-listing data is in the public domain. Use of ClinicalTrials.gov data must comply with the NLM terms of use.

Representative trial phases and designs

Phase III, 1L HER2-low

DESTINY-Breast06 — T-DXd vs chemotherapy in HER2-low or HER2-ultralow HR+ mBC after endocrine therapy.

Phase II, post-T-DXd resistance

Novel HER2-targeting ADCs, sacituzumab govitecan combinations.

Phase I/II, T-DXd + ICI

T-DXd + pembrolizumab or atezolizumab in TNBC HER2-low and HR+ HER2-low.

Frequently asked questions

Is HER2-ultralow now treatable?
DESTINY-Breast06 included a HER2-ultralow cohort with positive efficacy signals. FDA labels may expand pending full data; the field is evolving rapidly.

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