A phase II neoadjuvant study of cisplatin/paclitaxel with or without RAD001 in patients with triple-negative (TN) locally advanced breast cancer (BC).

摘要: TPS119 Background: In a fraction of TN BC, p63 is coordinately expressed with p73, and may be antagonizing p73 transcriptional tumor suppressive activity. Based on findings that mTOR inhibitors can activate enhance chemosensitivity cancer cells to cisplatin (known p73) paclitaxel inhibit expression), we hypothesized combined use RAD001 (mTOR inhibitor), cisplatin, would have synergistic effects in BC. Methods: This phase II trial, where patients measurable clinical stage II/ III BC are assigned (2:1) Cisplatin 25 mg/m2 ± 30 mg weekly for 3 weeks, followed by + 80 9 weeks until the time definitive surgery. Since June 2009 ten been accrued. Biopsy specimens obtained prior therapy, at 3-5 days after day 1 treatment. The main endpoint pathological complete response (pCR) each individual treatment arm. We also assess rate breas...