Neoadjuvant Treatment of gBRCA-Mutated HER2-Negative Breast Cancer With HRS-1167 and Famitinib ± Camrelizumab

Sponsor
Fudan University
Study ID
NCT06516289
Phase
PHASE2
Status
Recruiting
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Conditions

  • BRCA-Mutated Breast Carcinoma
  • HER2-negative Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • HRS-1167 — DRUG
    a highly selective PARP1 inhibitor
  • Famitinib — DRUG
    a tyrosine kinase inhibitor targeting VEGFR2, PDGFR, and c-kit
  • Camrelizumab — DRUG
    a humanised anti-programmed death-1 (anti PD-1) antibody

Study Details

This study is a prospective, open-label, multi-center, phase II clinical trial designed for HER2-negative breast cancer with pathogenic mutations in the germline gene (gBRCA1/2) that were indicated for neoadjuvant chemotherapy. The characteristics of this study are a precision treatment scheme without chemotherapy, the scheme of HRS-1167 combined with famitinib neoadjuvant therapy for patients with gBRCA mutations is explored, and the efficacy of combined immunotherapy is further explored according to the efficacy of the combination of the two drugs.

Key Dates

Start date
Sep 30, 2024
Status verified
Dec 2024
Primary completion
Jun 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
130 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Safety run-in
    HRS-1167 + famitinib
  • Experimental: Phase 2: Cohort A (HR+/HER2-, gBRCAm)
    HRS-1167 + famitinib, RP2D
  • Experimental: Phase 2: Cohort B (HR-/HER2-, gBRCAm)
    HRS-1167 + famitinib, RP2D
  • Experimental: Phase 2: Cohort C (HR+/HER2-, gBRCAm expansion cohort)
    HRS-1167 + famitinib, (RP2D) + camrelizumab
  • Experimental: Phase 2: Cohort D (HR-/HER2-, gBRCAm expansion cohort)
    HRS-1167 + famitinib, (RP2D) + camrelizumab

Primary Outcome Measure

Safety run-in: Incidence rate of dose-limiting toxicities (DLTs) [ Time Frame: 28±3 days ]

Central Contacts

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