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A Randomized, Phase III Study Comparing TAC (Docetaxel, Doxorubicin, Cyclophosphamide) With TCX ( Docetaxel, Cyclophosphamide, Capecitabine) as Adjuvant Treatment for High-risk Her2-Negative Breast Cancer
Some sub-analysis has shown anthracycline-based regimens are not effective in Her-2 negative breast cancer, while capecitabine is more effective in this group of patients. This is a prospective, randomised phase III trial, to compare the efficacy and safety profiles of two types of adjuvant chemotherapy regimens for HER2 negative, node positive or node-negative high-risk breast cancer patients. Control Arm: This includes 6 cycles of TAC 75/50/500 mg/m2 day 1 every 3 weeks. Experimental Arm: This includes 6 cycles of TC 75/500 mg/m2, day 1 every 3 weeks, concurrently with capecitabine 950 mg/m2, twice a day, via oral intake, for 14 days, and then a one-week rest period. Women with hormone receptor positive tumours must receive 5 years endocrine after the end of chemotherapy. Patients may receive radiotherapy when clinically indicated.
Details
| Lead sponsor | Peking Union Medical College Hospital |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 204 |
| Start date | 2011-05 |
| Completion | 2023-12 |
Conditions
- Breast Cancer
Interventions
- Docetaxel, Doxorubicin, Cyclophosphamide
- Docetaxel, Cyclophosphamide, Capecitabine
Primary outcomes
- disease-free survival — 10 years
the time from the date of surgery to locoregional or distant recurrence, second primary malignancy or death, whichever occurred first - overall survival — 10 years
the time from the date of surgery to the date of death from any cause
Countries
China