Multicenter, Randomized, Open Label Study Evaluating a Poly(ADP-ribose) Polymerase-1(PARP-1) Inhibitor, SAR240550 (BSI-201), Administered Twice Weekly or Weekly, in Combination With Gemcitabine/Carboplatin, in Patients With Metastatic Triple Negative Breast Cancer (mTNBC)
The duration of the study for a patient includes a period for inclusion of up to 3 weeks.
The patients may continue treatment until disease progression, unacceptable toxicity or
consent withdrawal, followed by a minimum of 30-day follow-up after the last study treatment
In case of discontinuation of study treatment, the patient will be considered as withdrawn
from study treatment, and will be followed as planned for at least 30 days after the last
administration of study treatment for safety purpose. In case of study treatment
discontinuation without disease progression, efficacy data will be collected every 6 weeks
until disease progression, death or end of study whatever comes first. After disease
progression, the patient will be followed-up every 12 weeks (3 months) for overall survival
until death or end of study.
The patients who benefit from the study treatment can continue until disease progression,
toxicity or willingness to stop.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate (ORR) as defined in the RECIST 1.1 version, as: complete response (CR) rate and partial response (PR) rate
up to a maximum follow up of 14 months
Clinical Sciences & Operations
Belgium: Federal Agency for Medicinal Products and Health Products