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

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 w

Trial Details

NCT ID
NCT07193394
Phase
PHASE2
Sponsor
Institut Curie
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Tucatinib (ONT-380)
  • Trastuzumab (Herceptin)
Locations (sample)
  • Bordeaux, France|44.84124,-0.58046
  • Limoges, France|45.83362,1.24759
  • Marseille, France|43.29695,5.38107
  • Nice, France|43.70313,7.26608
  • Nîmes, France|43.83665,4.35788

Key Eligibility Criteria

  • Age ≥ 18 years
  • Metastatic or unresectable breast cancer
  • HER2-negative (defined as having an IHC 0+, IHC 1+, or IHC 2+ and ISH non-amplified, per ASCO/CAP guidelines) on last assessable tumor sample
  • Having received ≥ 2 previous chemotherapy lines for advanced breast cancer: including at least one line of conjugated antibody, at the investigator…

For full eligibility, visit ClinicalTrials.gov.

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