Conditions: Metastatic Breast Cancer Locally Advanced Breast Cancer
Keywords: Breast Neoplasm
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 52
Healthy volunteers: no

Brief summary:
To determine how long Gemcitabine and Bevacizumab will stop the cancer from growing in patients with advanced breast cancer.

Detailed description:

Arms:
arm 1: Gemcitabine 2500 milligrams per square meter (mg/m\^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.

Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity.

Interventions: intervention 1: Gemcitabine intervention 2: Bevacizumab
Intervention descriptions: intervention 1: Gemcitabine 2500 mg/m\^2 IV over 30 minutes given on Day 1 q 14 days prior to bevacizumab until PD or unacceptable toxicity. intervention 2: Bevacizumab 10 mg/kg IV over 90 minutes at Cycle 1; infusion time may have been decreased for subsequent cycles. (For example, if the first infusion was tolerated without an infusion-associated adverse event \[AE\], the second infusion was delivered over 60 minutes. If the 60-minute infusion was well tolerated, all subsequent infusions were delivered over 30 minutes.)

Bevacizumab 10 mg/kg initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity.

Protocol document: