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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
246
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.
Physician's Choice Chemotherapy
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Wuhan Union Hospital of China
Wuhan, Hubei, China
Yichang Central People's Hospital
Yichang, Hubei, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
The Central Hospital Of Yong Zhou
Yongzhou, Hunan, China
Progression-Free Survival
Disease evaluation will be performed according to RECIST v1.1 criteria.
Time frame: 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.
Time frame: From date of randomization until the date of death from any cause, assessed up to 120 months.
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).
Time frame: From date of randomization until the date of first documented CR or PR, whichever came first, assessed up to 12 months.
Disease control rate
Proportion of patients achieving CR, PR, or stable disease (SD).
Time frame: 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.
Time frame: 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 frame: 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 frame: 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.
Time frame: Two years after randomization.
Safety Evaluation
Comparison of the incidence and severity of adverse events between the two groups.
Time frame: From randomization to 30 days after the last dose of study treatment.
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