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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab Combined With Pirfenidone and Chemotherapy Treatment Group | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| ORR(Objective Response Rate) | defined as the proportion of patients achieving complete response (CR) or partial response (PR) per RECIST v1.1. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| DCR(Disease Control Rate) | Proportion of patients with CR, PR, or stable disease (SD) ≥6 months | 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. |
| CBR(Clinical Benefit Rate) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huang Doctor | Contact | 0451-86298091 | huangfx@hrbmu.edu.cn |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C093844 | pirfenidone |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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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).
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|
Proportion of patients with CR, PR, or SD ≥6 months |
| through study completion, an average of 1 year". |
| PFS(Progression-Free Survival) | Time from enrollment to disease progression or death | up to 1 year |
| OS(Overall Survival) | Time from enrollment to death from any cause | up to 1 year |
| D017437 |
| Skin and Connective Tissue Diseases |