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

NCT07161791 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-09-09

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Harbin Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2026-12-31
Completion
2027-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07161791 on ClinicalTrials.gov