Overview

Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer

Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
Primary objective: - Compare disease-free survival in women with human epidermal growth factor receptor 2 (HER2)-neu-expressing node-positive or high-risk node-negative operable breast cancer treated with adjuvant doxorubicin, cyclophosphamide, and docetaxel with or without trastuzumab (Herceptin) vs trastuzumab, docetaxel, and carboplatin. Secondary objective: - Compare overall survival of participants treated with these regimens. - Compare the toxic effects (including cardiac) of these regimens in these participants. - Compare quality of life of participants treated with these regimens. - Compare pathologic and molecular markers for predicting efficacy of these regimens in these participants. - For substudy: Compare peripheral levels of shed HER2-neu extracellular domain with fluorescence in situ hybridization in predicting outcome in participants treated with these regimens.
Phase:
Phase 3
Details
Lead Sponsor:
Sanofi
Collaborator:
Cancer International Research Group (CIRG)
Treatments:
Carboplatin
Cyclophosphamide
Docetaxel
Doxorubicin
Liposomal doxorubicin
Trastuzumab