Two Regimens of SAR240550/Weekly Paclitaxel and Paclitaxel Alone as Neoadjuvant Therapy in Triple Negative Breast Cancer Patients

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 treatment. 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.