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

Sponsor
Harbin Medical University
Study ID
NCT07161791
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab Combined With Pirfenidone and Chemotherapy — DRUG
    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).

Study Details

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.

Key Dates

Start date
Sep 15, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab Combined With Pirfenidone and Chemotherapy Treatment Group
    Study Population: Patients with recurrent or metastatic triple-negative breast cancer (TNBC) who have progressed after first-line systemic therapy with immune checkpoint inhibitors (anti-PD-1/PD-L1). 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).

Primary Outcome Measure

ORR（Objective Response Rate） [ Time Frame: At the end of every 2 Cycles (each cycle is 21 days) , From first treatment Cycle until achieving complete response (CR) or partialresponse (PR) per RECIST v1.1.], assessed up to 1 year. ]

Central Contacts

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