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This study evaluates the efficacy and safety of camrelizumab, apatinib, and eribulin versus physician's choice chemotherapy in advanced TNBC.Primary Objectives: Assess improvements in progression-free survival (PFS) and overall survival (OS).Secondary Objectives: Compare objective response rate (ORR), disease control rate (DCR), clinical benefit rate (CBR), duration of response (DoR), time to response (TTR), two-year OS rate, biomarker analysis, and quality of life (QoL).Safety: Assess and compare adverse event incidence and severity.
This study aims to evaluate the efficacy and safety of the triplet regimen compared to physician's choice chemotherapy as a later-line treatment for advanced triple-negative breast cancer (TNBC). 1. Primary Objectives and Endpoints: To determine whether the combination of camrelizumab, apatinib, and eribulin improves progression-free survival (PFS) and overall survival (OS) compared to investigator's choice chemotherapy in advanced TNBC. 2. Secondary Objectives and Endpoints: To compare the following clinical parameters between the camrelizumab, apatinib, and eribulin combination and investigator's choice chemotherapy for advanced TNBC: -Objective response rate (ORR) Disease control rate (DCR) Clinical benefit rate (CBR) Duration of response (DoR) Time to response (TTR) Two-year overall survival rate (2-year OS rate) Biomarker analysis Quality of life (QoL) analysis 3.Safety Evaluation: Comparison of the incidence and severity of adverse events between the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Camrelizumab (200 mg, IV, Day 1) + Apatinib (250 mg, PO, QD) + Eribulin (1.4 mg/m², IV, Day 1 and Day 8) administered in 21-day cycles. |
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| Control Group | Active Comparator | Physician's Choice Chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab+Apatinib+Eribulin | Drug | Camrelizumab (200 mg, IV, Day 1) + Apatinib (250 mg, PO, QD) + Eribulin (1.4 mg/m², IV, Day 1 and Day 8) administered in 21-day cycles. |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | Disease evaluation will be performed according to RECIST v1.1 criteria. | Time from enrollment to the occurrence of predefined events, including disease progression or death, whichever came first, assessed up to 60 months. |
| Overall Survival | Death from any cause. | From date of randomization until the date of death from any cause, assessed up to 120 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | The percentage of patients in different groups whose tumor size reduction, meets the criteria for complete response (CR) or partial response (PR). | From date of randomization until the date of first documented CR or PR, whichever came first, assessed up to 12 months. |
| Disease control rate |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor and Peripheral Blood Biomarker Analysis | This analysis aims to identify biomarkers that predict treatment response, resistance, and prognosis in advanced triple-negative breast cancer (TNBC). Tumor Biomarker Analysis: Genetic and Molecular Profiling: Whole-exome sequencing (WES), RNA sequencing, and proteomics to identify mutations, gene expression patterns, and protein markers related to treatment response. Immune Microenvironment Assessment: Immunohistochemistry (IHC) and multiplex immunofluorescence to evaluate tumor-infiltrating lymphocytes (TILs), PD-L1 expression, and other immune-related markers. Peripheral Blood Biomarker Analysis: Measurement of inflammatory and immunomodulatory cytokines to assess systemic immune response. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jieqiong Liu, M.D., Ph.D. | Contact | +86-020-34071156 | liujieqiong01@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital | Recruiting | Guangzhou | Guangdong | China |
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| Physician's choice chemotherapy | Drug | Physician's Choice Chemotherapy |
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Proportion of patients achieving CR, PR, or stable disease (SD). |
| From date of randomization until the date of first documented CR, PR or SD, assessed up to 12 months. |
| Clinical Benefit Rate | Proportion of patients achieving CR, PR, or SD. | From date of randomization until the date of first documented CR, PR or SD for more than 6month, assessed up to 18 months. |
| Duration of Response | Time from the first assessment showing CR or PR to the first occurrence of progressive disease (PD) or death from any cause. | Time from the first assessment showing CR or PR to the first occurrence of PD or death from any cause, whichever came first, assessed up to 120 months. |
| Time to Response | Time from randomization to the first occurrence of CR or PR. | Time from randomization to the first occurrence of CR or PR, whichever came first, assessed up to 6 months |
| Two-Year Overall Survival Rate | Proportion of patients alive two years after randomization. | Two years after randomization. |
| Safety Evaluation | Comparison of the incidence and severity of adverse events between the two groups. | From randomization to 30 days after the last dose of study treatment. |
| Before treatment and after 2 cycles (each cycle is 21 days) of treatment, or disease progression. |
| QoL | Quality of life assessment will be conducted using the EORTC QLQ-BR23 questionnaire. Raw scores will be linearly transformed to a standardized scale ranging from 0 to 100 points. | At baseline upon enrollment and every 2cycles (each cycle is 21 days) of treatment, from date of randomization until the patient exits the study due to disease progression, adverse events, whichever came first, assessed up to 60 months. |
| The Affiliated Hospital of Guizhou Medical University | Recruiting | Guiyang | Guizhou | China |
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| Wuhan Union Hospital of China | Not yet recruiting | Wuhan | Hubei | China |
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| Yichang Central People's Hospital | Recruiting | Yichang | Hubei | China |
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| Xiangya Hospital of Central South University | Not yet recruiting | Changsha | Hunan | China |
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| The Central Hospital Of Yong Zhou | Recruiting | Yongzhou | Hunan | China |
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| Changhai Hospital of Shanghai | Recruiting | Shanghai | China |
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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 |
| D017437 | Skin and Connective Tissue Diseases |
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