Conditions: Breast Cancer
Keywords: Adjuvant therapy Bevacizumab Abraxane Early stage breast cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 197
Healthy volunteers: no

Brief summary:
The primary objective of this study was to compare the safety of dose-dense ABI-007 (Abraxane) 260 mg/m\^2 or Taxol 175 mg/m\^2 given every 2 weeks following dose-dense Adriamycin plus Cytoxan (AC) chemotherapy. Bevacizumab was administered at 10 mg/kg every 2 weeks throughout chemotherapy, and then at 15 mg/kg every 3 weeks following chemotherapy.

Detailed description:

Arms:
arm 1: Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m\^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46). arm 2: Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m\^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).

Interventions: intervention 1: Adriamycin and Cytoxan (AC) intervention 2: ABI-007 intervention 3: Taxol intervention 4: Bevacizumab intervention 5: pegfilgrastim
Intervention descriptions: intervention 1: Adriamycin (doxorubicin) and Cytoxan (cyclophosphamide) make up the chemotherapy regimen known as AC. Adriamycin 60 mg/m\^2 intravenous, plus Cytoxan 600 mg/m\^2 intravenous on Day 1 of each of four 2-week cycles (weeks 1-8). intervention 2: 260 mg/m\^2 IV on day 1 of each of four 2-week cycle, representing treatment cycles 5-8 (weeks 9-16) intervention 3: 175 mg/m\^2 intravenously (IV) on day 1 of each of four 2-week cycle, representing treatment cycles 5-8 (weeks 9-16) intervention 4: 10 mg/kg on day 1 of each of eight 2-week cycles (weeks 9-16), then 15 mg/kg on day 1 of each of ten three-week cycles (weeks 17-46). intervention 5: 6 mg subcutaneous (SC) on day 2 for each of the first four 2-week cycles (weeks 1-8). Pegfilgrastim 6 mg SC was administered on day 2 of cycles 6-8 (weeks 11-16) during taxane treatment only if necessary.

Protocol document: