Phase III trial of first-line treatment with gemcitabine plus docetaxel versus gemcitabine plus paclitaxel in women with metastatic breast cancer (MBC): A comparison of different schedules and treatment.

1073 Background: Weekly (W) administration of Gemcitabine+Docetaxel (G+D) or Gemcitabine+Paclitaxel (G+P) at low doses may be associated with greater efficacy and/or lower toxicity compared to the standard 3-weekly (3W) schedule. Methods: Patients (pts) (360) with MBC, that relapsed after one adjuvant/neoadjuvant regimen containing an anthracycline (unless contraindicated) that was completed for at least 12 months, were to be randomized equally to a) D 75mg/m2 on Day1 + G 1000mg/m2 on Days1/8 q3W ; b) P 175mg/m2 on Day1 + G 1250mg/m2 on Days1/8 q3W ; c) D 30mg/m2 + G 800mg/m2 on Days1/8/15 qW; or d) P 80mg/m2 + G 800mg/m2 on Days1/8/15 qW. Primary endpoint was time to progression (TTP). Secondary endpoints were overall survival (OS), overall response rate (ORR) and overall toxicity (T). Results: Due to slow accrual rate, a futility analysis was performed to evaluate the chance of observing a significant result in favour of the alternative hypothesis. The results from this led to early study termination. 2...