Gemcitabine plus carboplatin for patients with pretreated, metastatic breast cancer: A phase II trial

10635 Background: In search for treatment regimens which can be applied in anthracycline- and taxane-pretreated patients, the combination of gemcitabine and cisplatin was shown to be effective in several trials. To improve on tolerability and handling of the regimen, cisplatin was replaced by carboplatin in the present trial. Methods: Patients with intensively pretreated, metastatic breast cancer (age 18 to 70 years) and measurable disease were treated with gemcitabine (1000 mg/m2 iv on days 1 and 8) and carboplatin (AUC 4 iv on day 1) in a 3-week regimen. The trial was performed as a 2-stage phase II study according to the optimal design described by Simon (p0 = 0.1, p1 = 0.3, α = 0.05, β = 0.1) with overall remission rate (according to RECIST) as the the primary objective. Results: Of 39 recruited patients (median age: 60 years, range 29 to 77 years) response data are available from 35 patients. A positive hormone receptor status was observed in 77% of patients, and 31% of patients were Her-2 overexpres...