A Study of Camrelizumab in Combination With Chemotherapy Regimen Comparative Chemotherapy Regimen for Metastatic Triple-negative Breast Cancer

Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study ID
NCT05134194
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

Study Details

Approximately 104 subjects with recurrent or metastatic IM triple negative breast cancer were planned to be included in the study, and screened eligible subjects were randomly assigned in a 1:1 ratio to treatment with the combination of Camrelizumab and investigator's choice of chemotherapy (test arm), treatment with investigator's choice of chemotherapy (control arm), and the stratification factor was liver metastasis (with vs without). After enrollment, subjects in the test group were treated with Camrelizumab 200 mg IV every 3 weeks for one cycle. The investigator's choice of single agent chemotherapy regimen (capecitabine, eribulin, gemcitabine, or vinorelbine) was every 3 weeks for one cycle until disease progression, intolerable toxicity, withdrawal of informed consent, or discontinuation at the investigator's discretion.

Key Dates

Start date
Jan 17, 2022
Status verified
Apr 2024
Primary completion
Jan 17, 2022
Completion
Dec 15, 2022

Study Design

Enrollment
1 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Camrelizumab in combination with capecitabine or eribulin or gemcitabine or vinorelbine
  • Experimental: Arm B
    Capecitabine or eribulin or gemcitabine or vinorelbine

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: Treatment was assessed every 6 weeks after treatment initiation（up to 30 weeks）, regardless of whether treatment was delayed or interrupted, until disease progression or study end, whichever occurred first. ]

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