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
Study ID
NCT06889688
Phase
PHASE3
Status
Recruiting
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Conditions

  • Breast Cancer Stage IV
  • Triple -Negative Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • Physician's choice chemotherapy — DRUG
    Physician's Choice Chemotherapy

Study Details

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.

Key Dates

Start date
Feb 21, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Jun 1, 2029

Study Design

Enrollment
246 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Group
    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.
  • Active Comparator: Control Group
    Physician's Choice Chemotherapy

Primary Outcome Measure

Progression-Free Survival [ Time Frame: Time from enrollment to the occurrence of predefined events, including disease progression or death, whichever came first, assessed up to 60 months. ]

Central Contacts

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