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

StatusRecruiting
PhasePhase 3
Started2025-02-21
View on ClinicalTrials.gov ↗

Amendment history

2026-04-19
Active, Not Recruiting→Recruiting Study Status, Conditions, Eligibility, Contacts/Locations v2
Trial statusActive, Not Recruiting→Recruiting
Primary completion date2030-09-20→2028-12-31
Completion date2031-03-31→2029-06-01
Start date2025-04-01→2025-02-21
Study sites6→7
Eligibility criteria+94 characters
[...] th at least one measurable lesion per RECIST v1.1 criteria. PreviouslyPatients who have received ≥at least 1 lineand up to 4 lines of prior systemic therapy for metastatic or locally advanced unresectable triple-negative breast cancer (TNBC) with disease progression. Prior systemic therapy (including ≥at least 1 line of chemotherapy and neoadjuvant/adjuvant chemotherapy) must haveinclude includedat least a taxane or anthracycline. RecurrenceSubjects who relapse within 6 months after completingcompletion of neoadjuvant/adjuvant chemotherapy isare considered as failurehaving offailed first-line [...]
2025-05-13
Not Yet Recruiting→Active, Not Recruiting Study Identification, Study Status, Oversight, Contacts/Locations v1
Trial statusNot Yet Recruiting→Active, Not Recruiting
Study sitescontacts updated at 6 of 6 sites
Study titlerevised
Phase III Trial of Camrelizumab+Apatinib+Eribulin Vsvs. Physician's Choice Chemotherapy in Advanced Triple-Negative Breast Cancer
2025-03-19
Original filing
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.
Trial Details
NCT Number NCT06889688
Lead Sponsor Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions Breast Cancer Stage IV, Triple -Negative Breast Cancer
Enrollment 246 participants
Start Date 2025-02-21
Primary Completion 2028-12-31 (estimated)
Study Completion 2029-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-23