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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHarbin Medical University

About this trial

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.

Eligibility criteria

Qualifiers

Female, aged 18-70 years.

Histologically confirmed recurrent/metastatic TNBC (ER-negative: IHC ER <1%; PR-negative: IHC PR <1%; HER2-negative: IHC -/+, or IHC ++ but FISH/CISH negative), with at least one measurable lesion per RECIST v1.1.

ECOG performance status 0-2.

Estimated life expectancy ≥3 months.

Disqualifiers

Concurrent participation in another interventional cancer trial.

Received other antitumor therapy within 14 days before first dose.

Prior treatment with pirfenidone.

Untreated active brain metastases or leptomeningeal disease.

Trial design

Treatments tested in this trial

  • Camrelizumab Combined With Pirfenidone and Chemotherapy

Treatment groups

12 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators