NCT06516289

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

Neoadjuvant Treatment of gBRCA-Mutated HER2-Negative Breast Cancer With HRS-1167 and Famitinib/ HRS-1167, Famitinib and Camrelizumab: A Prospective, Open-label, Multicenter, Phase II Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. The study consists of a safety run-in period to explore the safety of HRS-1167 combined with famitinib, which is used to provide a recommended dose for the combination of HRS-1167 and famitinib. The latter phase II period is used to explore the efficacy of HRS-1167 plus famitinib /HRS-1167 plus famitinib plus camrelizumab as neoadjuvant therapy for gBRCA-mutated HER2-negative breast cancer. The primary endpoints in safety run-in period: the incidence of dose-limiting toxicity (DLT), the incidence and severity of adverse events (AE) and serious adverse events (SAE) ; in phase 2: the rate of pathological complete response (pCR) after surgery for each cohort as assessed by the investigator. Secondary endpoints included residual cancer burden (RCB) score, 3-year event-free survival (EFS), objective response rate (ORR), complete cell cycle arrest (CCCA) rate for HR+/HER2 - breast cancer, safety, and translational exploration study.

Conditions

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

Interventions

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

Timeline

• Start date: 2024-09-30
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2024-07-23
• Last updated: 2024-12-12

Locations

1 site across 1 country: China