This open label, multi-centre phase II study will assess the efficacy and safety of single agent SC10914 in metastatic breast cancer patients with gBRCA 1/2 mutations.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
78
SC10914 400mg tid
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGObjective Response Rate (ORR)
Using Independent Central Review Data Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)
Time frame: Assessed up to a maximum of 30 months
Progression-free Survival (PFS)
Using Independent Central Review According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)
Time frame: Assessed up to a maximum of 30 months
Overall Survival (OS)
from eligible until death due to any cause
Time frame: Assessed up to a maximum of 30 months
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