Conditions: Breast Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 147
Healthy volunteers: no

Brief summary:
The gemcitabine-paclitaxel and gemcitabine-platinum combinations have shown promise in the treatments of MBC; however, the optimal dosing schedules for these combinations have not yet been determined. The primary objective of this study is to compare the response rates of the gemcitabine-paclitaxel, gemcitabine-carboplatin, and gemcitabine-cisplatin combinations when administered on a biweekly schedule in metastatic breast cancer.

Detailed description:

Arms:
arm 1: gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.

paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles. arm 2: gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.

carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles. arm 3: gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.

cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles

Interventions: intervention 1: gemcitabine intervention 2: paclitaxel intervention 3: carboplatin intervention 4: cisplatin
Intervention descriptions: intervention 1: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles intervention 2: 150 mg/m2, IV, every 14 days x 8 cycles intervention 3: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles intervention 4: 50 mg/m2, IV, every 14 days x 8 cycles

Protocol document: