NCT07161791

Camrelizumab, Pirfenidone, and Chemotherapy in the Treatment of Advanced Triple-Negative Breast Cancer

Exploratory Clinical Study of Camrelizumab Combined With Pirfenidone and Chemotherapy in the Treatment of Advanced Triple-Negative Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Harbin Medical University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-arm, exploratory clinical study, planned to enroll 12 patients with advanced triple-negative breast cancer who have received first-line systemic treatment with immune checkpoint inhibitors. The treatment regimen will continue until disease progression, intolerable toxicity, withdrawal of informed consent, or investigator's judgment that treatment must be terminated. Imaging assessment will be performed according to RECIST 1.1 criteria, with the research center's assessment results as the final outcome. Subjects who discontinue treatment will enter the follow-up period: 1) Safety follow-up until 30 days after the last dose; 2) Subjects who discontinue treatment for reasons other than progression disease (PD) or death will undergo efficacy follow-up until disease progression, initiation of other anti-tumor drugs, or death, whichever comes first; 3) All subjects will enter the trial period upon enrollment and receive camrelizumab combined with pirfenidone and chemotherapy.

Conditions

• Breast Cancer
• Triple Negative Breast Cancer (TNBC)

Interventions

Type	Name	Description
DRUG	Camrelizumab Combined With Pirfenidone and Chemotherapy	Treatment Regimen: Camrelizumab: 200 mg intravenous (IV) every 3 weeks (q3w). Pirfenidone: 200 mg three times daily (tid), escalated to 600 mg tid based on tolerability. Chemotherapy: Investigator's choice of standard regimens (e.g., paclitaxel 175 mg/m² IV q3w or capecitabine 1000 mg/m² orally bid on days 1-14 of a 21-day cycle).

Timeline

• Start date: 2025-09-15
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2025-09-09
• Last updated: 2025-09-09