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A Prospective, Randomized, Open, Multi-center Phase III Clinical Study Comparing Efficacy and Safety of Sequential T-FEC and TX-XEC as Post-operative Adjuvant Chemotherapy Options for the Treatment of Triple-negative Breast Cancer
Recent clinical studies showed that triple-negative breast cancer patients (ER-/PR-/HER2-) may benefit more from Capecitabine chemotherapy. However, the optimum post-operative adjuvant Capecitabine chemotherapy regimen has not been determined for Chinese population with triple-negative breast cancer. Thus it's necessary to conduct a multi-center Phase III clinical trial to verify efficacy and safety of Capecitabine in the treatment of triple-negative breast cancer. In this study, a prospective, randomized, open, multi-center Phase III clinical study was conducted to compare efficacy and safety of sequential Docetaxel followed by Fluorouracil/Epirubicin/Cyclophosphamide (FEC) and sequential Docetaxel and Capecitabine followed by Capecitabine/Epirubicin/Cyclophosphamide (XEC) as post-operative adjuvant chemotherapy in the treatment of triple-negative breast cancer in Chinese population.
Details
| Lead sponsor | China Breast Cancer Clinical Study Group |
|---|---|
| Phase | Phase 3 |
| Status | UNKNOWN |
| Enrolment | 636 |
| Start date | 2012-06 |
| Completion | 2020-05 |
Conditions
- Breast Cancer
Interventions
- 5-Fu/epirubicin/CTX following Docetaxel
- Docetaxel/capecitabine followed by XEC
Primary outcomes
- 5-year disease free survival — 5 year after the completion of chemotherapy
Including local relapse, distant metastasis, contralateral breast cancer, second primary cancer or death from any cause
Countries
China