Conditions: Breast Cancer
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 109
Healthy volunteers: no

Brief summary:
This single-arm study was designed to evaluate the efficacy and safety of oral Xeloda plus intravenous Avastin as first-line treatment in women with metastatic breast cancer. Patients received Xeloda 1000 mg/m² orally (PO) twice daily (BID) on Days 1-15, and Avastin 15 mg intravenously (IV) on Day 1 of each 3-week cycle. The anticipated time on study treatment was until disease progression or unacceptable toxicity. The target sample size was \<100 individuals.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Capecitabine intervention 2: Bevacizumab
Intervention descriptions: intervention 1: 1000 mg/m² PO BID on Days 1-15 of each 3-week cycle intervention 2: 15 mg IV on Day 1 of each 3-week cycle

Protocol document: