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ACTIVE NOT RECRUITING
NCT06889688
PHASE3

Phase III Trial of Camrelizumab+Apatinib+Eribulin vs. Physician's Choice Chemotherapy in Advanced Triple-Negative Breast Cancer

Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

View on ClinicalTrials.gov

Summary

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.

Official title: A Multicenter, Phase III, Randomized Controlled Trial Comparing Camrelizumab Plus Apatinib and Eribulin Versus Physician's Choice Chemotherapy in the Treatment of Advanced Triple-Negative Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

246

Start Date

2025-04-01

Completion Date

2031-03-31

Last Updated

2025-05-15

Healthy Volunteers

No

Interventions

DRUG

Camrelizumab+Apatinib+Eribulin

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.

DRUG

Physician's choice chemotherapy

Physician's Choice Chemotherapy

Locations (6)

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