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RECRUITING
NCT06516289
PHASE2

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

Sponsor: Fudan University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2024-09-30

Completion Date

2027-06

Last Updated

2024-12-12

Healthy Volunteers

No

Interventions

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

Locations (1)

Breast cancer institute of Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China