Randomized, Open-label, Phase 2 Study of the Efficacy and Safety of Weekly Paclitaxel Single-agent and Two Different Regimens of the PARP-1 Inhibitor SAR240550 (BSI-201) in Combination With Weekly Paclitaxel, as Neoadjuvant Therapy in Patients With Stage II-IIIA Triple Negative Breast Cancer (TNBC)
Active study treatment will be given either as twice weekly administration (Day 1 and Day 4)
or as weekly administration (Day 1) for a maximum of 24 infusions for Arm A and for a
maximum of 12 infusions for Arm B. In all study arms, treatment will be given until
definitive surgery, the first sign of disease progression, unacceptable toxicity or
withdrawal of patient consent.
Definitive surgery will be performed within 2 to 4 weeks after the last dose of study
Patients who complete all the study treatment or who withdraw consent or experience
intolerable toxicity will undergo surgery according to local practices.
The cut-off date for the primary analyses will be 30 days after the last study treatment
administration or the date of the definitive surgery, whichever comes last.
The maximum follow up for each individual patient will be until death or 5 years after the
definitive surgery date whatever happens first.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Pathological Complete Response (pCR) rate defined as the complete absence of invasive carcinoma on histological examination of the breast at the time of definitive surgery and confirmed by blinded centralized review
at the time of definitive surgery
Clinical Sciences & Operations
Spain: Ministry of Health