At a glance
ClinicalIndex Comparison Record- ✓Histologically proven breast cancer with ≤60 days between definitive surgery (mastectomy or breast-conserving with axillary assessment) and registration
- ✓Node-positive (≥1 positive axillary node among ≥6 resected) OR high-risk node-negative (pN0 among ≥6 nodes or negative sentinel biopsy plus ≥1 of: tumor >2 cm, ER/PR negative, grade 2-3, or age <35)
- ✓HER2neu gene amplification confirmed by FISH analysis from designated central laboratory
- ✓ER and/or PR status known at randomization
- ✕Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy)
- ✕Prior anthracycline, taxoid, or platinum therapy for any malignancy
- ✕Prior radiation therapy for breast cancer
- ✕Bilateral invasive breast cancer
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multicenter Phase III Randomized Trial Comparing Doxorubicin and Cyclophosphamide Followed By Docetaxel (AC-T) With Doxorubicin and Cyclophosphamide Followed By Docetaxel and Trastuzumab (Herceptin)(AC-TH) and With Docetaxel, Carboplatin and Trastuzumab (TCH) In The Adjuvant Treatment Of Node Positive and High Risk Node Negative Patients With Operable Breast Cancer Containing The HER2 Alteration
In Brief
A Phase 3 clinical trial evaluating Doxorubicin, Cyclophosphamide, and 3 other interventions for Breast Neoplasms. Completed, enrolled 3,222 participants across 42 sites in 42 countries.
Detailed 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.