RecruitingPhase 2NCT06516289

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

Sponsor

Fudan University

Enrollment

130 participants

Start Date

Sep 30, 2024

Study Type

INTERVENTIONAL

Conditions

HER2-negative Breast Cancer BRCA-Mutated Breast Carcinoma

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs before surgery in women with a specific type of breast cancer: HER2-negative breast cancer with a BRCA1 or BRCA2 gene mutation. The drugs include HRS-1167 (a PARP inhibitor that blocks cancer cell repair), famitinib (which cuts off tumor blood supply), and possibly camrelizumab (an immunotherapy). The goal is to shrink the tumor before surgery. **You may be eligible if...** - You are a woman aged 18–70 - You have a confirmed invasive breast cancer that is HER2-negative - You carry a harmful BRCA1 or BRCA2 gene mutation - Your cancer has spread to nearby lymph nodes, or the primary tumor is large enough to require neoadjuvant (pre-surgery) treatment - Inflammatory breast cancer is not present **You may NOT be eligible if...** - You are HER2-positive - You do not carry a BRCA1 or BRCA2 gene mutation - You have inflammatory breast cancer - You have metastatic (distantly spread) disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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