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 included in experimental group and 31 in standard group. Median age at diagnosis was 47 years. Median tumor size was 6 cm in both groups. Clinical response was achieved in 58% experimental group y 40% standard group p = 0.158, pCR was achieved in 39.2% and 58.6% respectively p = 0.344. Side effects were more common in experimental arm including anemia, neutropenia, nausea, vomiting and nephropathy, all of with statistics significance. Conclusions: There is a trend to improve pCR by adding cisplatin to standard chemotherapy, however there is also more hematological and non-hematological toxicity. Cisplatin addition improves in 30% our goal, and it is comparable with other literature reports.