Randomized phase II trial to evaluate the safety and efficacy of neoadjuvant cisplatin in combination with taxanes-anthracyclines vs taxanes-anthracyclines alone in locally advanced triple negative breast cancer.

e12024 Background: Triple negative breast cancer in our center represents 21% of all breast cancer cases. In these group of patients, its been suggested that cisplatin could improve breast cancer outcomes. The aim of this study was to evaluate the pathologic complete response (pCR) improvement with the addition of cisplatin to standard chemotherapy Methods: 80 patients were planned to be included, 61 patients were randomized in a 1:1 ratio. Standard group (A) received weekly paclitaxel 80 mg/m2 by 12, followed to 5FU, doxorubicin and cyclophosphamide 500/50/500 mg/m2 every 3 weeks times 4. Experimental group (B) received cisplatin 30 mg/m2 plus weekly paclitaxel 80 mg/m2 by 12, followed to cisplatin 75 mg/m2 plus doxorubicin 50 mg/m2 every 3 weeks for 4 cycles, followed by surgery. pCR was defined by the absence of tumor cells in the breast and lymph nodes. Safety analysis was made with CTC NCI v4.0. Local ethics committee approved the protocol. This is an interim analysis. Results: 30 patients were inclu...