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Tucatinib and Trastuzumab in HER3-mutant and HER2-not Amplified Metastatic Breast Cancer

NCT07193394 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-02-23

No results posted yet for this study

Summary

The H3RAKLES trial would allow patients with a progressive metastatic breast cancer to have access to one more line of systemic therapy. Patients included in this trial will have already received at least two lines of chemotherapy (and potentially several lines of endocrine therapy for patients with a HR+ disease). In this setting, few treatments have demonstrated a clinically meaningful benefit, and any additional option is valuable. Furthermore, the pre-clinical and clinical rationale indicate a high probability of clinical benefit, as previously shown in Table 1, with all patients treated with trastuzumab and a TKI targeting HER2 displaying a response. Besides, with several years of hindsight for the combination of lapatinib, trastuzumab and capecitabine, we expect excellent tolerance with the same treatment without capecitabine.

The H3RAKLES single-arm phase II trial will evaluate the combination of tucatinib, a HER2 TKI, and trastuzumab, a HER2-directed antibody in patients with a HER2-not amplified metastatic or unresectable breast cancer harboring an activating ERBB3 mutation. To demonstrate the actionability of ERBB3 mutations, all patients will receive a combination of trastuzumab and tucatinib, in 3-weeks cycles.

Conditions

  • Metastatic Breast Cancer ( HER2 Negative)
  • Unresectable Breast Cancer

Interventions

DRUG

Tucatinib (ONT-380)

Patients with a HER2-not amplified metastatic or unresectable breast cancer harboring an activating ERBB3 mutation will receive experimental treatment with tucatinib and trastuzumab combination

DRUG

Trastuzumab (Herceptin)

Patients with a HER2-not amplified metastatic or unresectable breast cancer harboring an activating ERBB3 mutation will receive experimental treatment with tucatinib and trastuzumab combination

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Eurofins

    collaborator INDUSTRY

  • UNICANCER

    collaborator OTHER

  • Institut Curie

    lead OTHER

Principal Investigators

  • François-Clément Bidard, Prof. · Institut Curie

  • Sandra BIDARD · Institut Curie

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2028-12-07
Completion
2029-06-08

Countries

  • France

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07193394 on ClinicalTrials.gov