Conditions: Breast Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 56
Healthy volunteers: no

Brief summary:
This single arm study will assess the efficacy and safety of sequential neoadjuvant chemotherapy and bevacizumab (Avastin), before surgery and/or radiotherapy, in participants with inflammatory or locally advanced operable breast cancer. Participants will receive 5-fluorouracil, epidoxorubicin and cyclophosphamide (FEC), followed by paclitaxel, given concomitantly with bevacizumab. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Detailed description:

Arms:
arm 1: Participants will receive FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.

Interventions: intervention 1: 5-fluorouracil intervention 2: Epidoxorubicin intervention 3: Cyclophosphamide intervention 4: Paclitaxel intervention 5: Bevacizumab
Intervention descriptions: intervention 1: 600 milligrams per meter squared (mg/m\^2) as an intravenous (i.v.) bolus over ≤15 minutes every 3 weeks for 4 cycles. intervention 2: 90 mg/m\^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles. intervention 3: 600 mg/m\^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles. intervention 4: Paclitaxel was administered at 80 mg/m\^2 i.v. over 1 hour weekly for 12 weeks. intervention 5: Bevacizumab was administered at 10 milligrams per kilogram (mg/kg) i.v. every 2 weeks for 6 cycles.

Protocol document: