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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Camrelizumab Combined With Pirfenidone and Chemotherapy
DrugTreatment 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).
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Camrelizumab Combined With Pirfenidone and Chemotherapy Treatment GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
ORR（Objective Response Rate）
defined as the proportion of patients achieving complete response (CR) or partial response (PR) per RECIST v1.1.
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.Secondary outcomes
1
DCR（Disease Control Rate）
Proportion of patients with CR, PR, or stable disease (SD) ≥6 months
Time frame
Patients undergo imaging evaluation in every 2 cycles（each cycyle is 21 days）until achieving SD per RECIST v1.1 or through study completion, assessed up to 1 year.2
CBR（Clinical Benefit Rate）
Proportion of patients with CR, PR, or SD ≥6 months
Time frame
through study completion, an average of 1 year".3
PFS（Progression-Free Survival）
Time from enrollment to disease progression or death
Time frame
up to 1 year4
OS（Overall Survival）
Time from enrollment to death from any cause
Time frame
up to 1 yearLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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