Trial intelligence / Profile preview

Camrelizumab and Pirfenidone in Advanced TNBC

NCT07161791Phase 2

Key facts

Status: Not yet recruiting
Start: Sep 2025
Primary completion: Dec 2026
Sponsor: Harbin Medical University
Modality: Small Molecules

Drugs: pirfenidone
Conditions: triple-negative breast cancer (TNBC)

Overview

Phase 2, open-label, single-arm trial of pirfenidone in triple-negative breast cancer (TNBC), sponsored by Harbin Medical University. Primary endpoint: Objective Response Rate at 1 year. Planned start Sep 2025; status: not yet recruiting.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Camrelizumab + Pirfenidone + Chemotherapy
Camrelizumab combined with pirfenidone and investigator's choice of chemotherapy (paclitaxel or capecitabine).

Who it enrols

Female patients aged 18-70 with recurrent/metastatic TNBC who have progressed after first-line chemotherapy + PD-1/PD-L1 inhibitor. Must have measurable disease, ECOG 0-2, and adequate organ function. Excludes prior pirfenidone use, active brain metastases, and autoimmune disease.

Endpoints

Primary

Objective Response Rate1 year

Secondary

Disease Control Rate1 year
Clinical Benefit Rate1 year
Progression-Free Survival1 year
Overall Survival1 year

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