Conditions: Breast Cancer
Keywords: Breast Cancer Adjuvant Doxorubicin Cyclophosphamide Paclitaxel Ixabepilone TITAN
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 614
Healthy volunteers: no

Brief summary:
This is a randomized, Phase III, open-label, multicenter study.

Detailed description:
Patients will be randomized in a 1:1 ratio to receive one of two different treatment arms. Patients in treatment arm 1 will receive AC followed by ixabepilone. Patients in treatment arm 2 will receive AC followed by weekly paclitaxel.

Arms:
arm 1: Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 administered for 4 cycles of 21 days each, followed by ixabepilone at 40 mg/m2 given for 4 cycles of 21 days each. arm 2: Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 administered for 4 cycles of 21 days each, followed by paclitaxel at 80 mg/m2 weekly for 12 weeks.

Interventions: intervention 1: Doxorubicin intervention 2: Cyclophosphamide intervention 3: Ixabepilone (Ixempra) intervention 4: Paclitaxel (Taxol)
Intervention descriptions: intervention 1: Doxorubicin 60 mg/m2 intervention 2: Cyclophosphamide 600 mg/m2 intervention 3: Ixabepilone 40 mg/m2 intervention 4: Paclitaxel 80 mg/m2

Protocol document: