The study is being conducted to evaluate the tolerability, safety and efficacy of SHR-1210 in combination with Apatinib and Fluzoparib in subjects with recurrent and metastatic triple negative breast cancer
Drug: SHR-1210 + Apatinib +Fluzoparib SHR-1210 will be administered as an intravenous infusion, Apatinib tablets will be given orally, Fluzoparib capsule will be given orally 28 days per cycle, until disease progression or unacceptable toxicity. Treatment group : PD-1 antibody SHR-1210 combination with apatinib and fluzoparib
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
SHR-1210 will be administered as an intravenous infusion Apatinib tablets will be given orally Fluzoparib capsule will be given orally 28 days per cycle, until disease progression or unacceptable toxicity.
Beijing Cancer Hosptial
Beijing, Beijing Municipality, China
Dose Limiting Toxicity (DLT)
Dose Limiting Toxicity
Time frame: First cycle (28 days)
Adverse Events and Serious Adverse Events
AEs and SAEs
Time frame: from the first drug administration to within 90 days for the last SHR-1210 dose
Overall Response Rate (ORR)
Time frame: up to 12 months (approx) from the start of treatment
Duration of response (DoR)
Time frame: up to 12 months (approx) from the start of treatment
Disease Control Rate
DCR
Time frame: up to 12 months (approx) from the start of treatment
Progression-Free-Survival
PFS
Time frame: up to 12 months (approx) from the start of treatment
12-months overall survival rate
12-months overall survival rate
Time frame: From the start of treatment to 1 year
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