Conditions: Breast Cancer
Keywords: Breast Cancer Cancer of Breast Cancer of the breast Breast Neoplasms
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 187
Healthy volunteers: no

Brief summary:
This study will compare the cancer response to both treatments for locally advanced or metastatic breast cancer

Detailed description:

Arms:
arm 1: paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days arm 2: paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days

Interventions: intervention 1: gemcitabine intervention 2: paclitaxel intervention 3: bevacizumab
Intervention descriptions: intervention 1: 1500 mg/m2, IV day 1 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity intervention 2: 90 mg/m2, IV, day 1, day 8 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity intervention 3: 10 mg/kg, IV, day 1 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity

Protocol document: