At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II, Open Label, Neoadjuvant Study of Bevacizumab in Patients With Inflammatory or Locally Advanced Breast Cancer
In Brief
A Phase 2 clinical trial evaluating 5-fluorouracil, Epidoxorubicin, and 3 other interventions for Breast Cancer. Completed, enrolled 56 participants across 8 sites.
Detailed 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.
Study Details
Timeline
Interventions
600 milligrams per meter squared (mg/m\^2) as an intravenous (i.v.) bolus over ≤15 minutes every 3 weeks for 4 cycles.
90 mg/m\^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles.
600 mg/m\^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles.
Paclitaxel was administered at 80 mg/m\^2 i.v. over 1 hour weekly for 12 weeks.
Bevacizumab was administered at 10 milligrams per kilogram (mg/kg) i.v. every 2 weeks for 6 cycles.