Abstract
573 Purpose: This randomized multicenter phase III trial evaluated the efficacy and safety of trastuzumab with paclitaxel 175 mg/m2 and carboplatin AUC=6 (TPC) versus trastuzumab with paclitaxel 175 mg/m2 (TP) in women with HER-2 overexpressing metastatic breast cancer. Methods: Between November 1998 and May 2002, 196 patients (pts) with HER-2 overexpression of 2+ or 3+ by immunohistochemistry were randomized; 188 were eligible; 93 pts received TPC and 95 pts received TP. In both arms, chemotherapy was delivered every 3 weeks for at least 6 cycles and weekly trastuzumab until progression. Results: Overall response (OR) and time to progression (TTP) were significantly improved with TPC compared to TP; OR for TPC was 52%, compared to 36% for TP (P = .04). Median TTP was 11.9 months for TPC and 6.8 months for TP (P = .02). This improvement was greater in HER2 3+ pts, with OR of 57% versus 37% (P = .03), and median TTP of 14.6 months vs 6.9 months (P = .006), for TPC and TP, respectively. There was a trend in...
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