Conditions: Breast Cancer Breast Neoplasms Cancer of the Breast
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 475
Healthy volunteers: no

Brief summary:
This is a phase III randomized study between the docetaxel/gemcitabine and docetaxel/ capecitabine doublets, with crossover to the alternate agent. The experimental arm will receive gemcitabine 1000 mg/m2 intravenous (IV) over 30 minutes days 1 and 8 and docetaxel 75 mg/m2 IV day 1 over 1 hour repeated every three weeks. The comparator arm will receive docetaxel 75 mgm/m2 IV day 1 over 1 hour and oral capecitabine 1000 mg/m2 twice daily, days 1 through 14 repeated every three weeks. Patients who progress on the experimental arm, will be treated with capecitabine as dosed on the comparator arm. Patients who progress on the comparator arm will be treated with gemcitabine as dosed on the experimental arm.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: gemcitabine intervention 2: docetaxel intervention 3: capecitabine
Intervention descriptions: intervention 1: 1000 mg/m2, intravenous (IV) day 1 and day 8 every 21 days until disease progression intervention 2: 75 mg/m2, intravenous (IV), every 21 days until disease progression intervention 3: 1000 mg/m2, by mouth (PO) twice a day (BID), days 1-14, every 21 days until disease progression

Protocol document: