Conditions: Breast Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 225
Healthy volunteers: no

Brief summary:
This study will assess the efficacy and safety of intravenous (IV) trastuzumab (Herceptin) and IV docetaxel (Taxotere), with or without oral capecitabine (Xeloda), in women with previously untreated HER2-positive advanced and/or metastatic breast cancer.

Detailed description:

Arms:
arm 1: Participants will receive dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. arm 2: Participants will receive triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal.

Interventions: intervention 1: Xeloda intervention 2: Taxotere intervention 3: Herceptin
Intervention descriptions: intervention 1: Participants will receive oral Xeloda, 950 mg/m\^2 twice a day on Days 1 to 14 of each 21-day cycle. intervention 2: Participants will receive Taxotere, 75 milligrams per meter-squared (mg/m\^2) in the Herceptin + Taxotere + Xeloda arm or 100 mg/m\^2 in the Herceptin + Taxotere arm, via IV infusion on Day 1 of each 21-day cycle. The lower starting dose will be used in the triple-therapy arm. intervention 3: Participants will receive Herceptin, 6 milligrams per kilogram (mg/kg) via IV infusion, on Day 1 of each 21-day cycle. The first dose will be a loading dose of 8 mg/kg in Cycle 1; the dose of 6 mg/kg will be given from Cycle 2 onward.

Protocol document: