Phase III Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel With or Without Trastuzumab as Adjuvant Treatment for Women With HER-2 Over-Expressing or Amplified Node Positive or High-Risk Node Negative Breast Cancer
Phase 3NCT00005970
- Population
- Women with surgically removed HER2-positive breast cancer
- Design
- Randomised three-regimen trial; the joint analysis with NSABP B-31 compared group A with group C (concurrent trastuzumab); group B (trastuzumab after paclitaxel) was excluded from the joint analysis. See trial b31-n9831-joint.
- Arms
- Group A (control): Doxorubicin and cyclophosphamide followed by weekly paclitaxel
- Group B (experimental): The same regimen followed by 52 weeks of trastuzumab after paclitaxel
- Group C (experimental): The same regimen plus 52 weeks of trastuzumab initiated concomitantly with paclitaxel
- People
- Romond EH