drugset / Trial / NCT01849380
Neoadjuvant ECS Versus ECF in Local Advanced Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
S-1 is a newly developed novel oral dihydrouracil dehydrogenase inhibiting fluoro-pyrimidine drug consisting of i M tegafur (FT), 0.4 M 5-chloro-2, 4-dihydroxypyrimidine (gimeracil), and 1 M potassium oxonate (oteracil), with efficient antitumor activity and low gastrointestinal toxicity. Several studies have proved the safety and efficacy of single agent S-1 in metastatic breast cancer. This study is designed to further investigate and compare the efficacy and safety of Epirubicin-cyclophosphamide-S-1(ECS) vs. Epirubicin-cyclophosphamide-5-fluorouracil (ECF) as neoadjuvant chemotherapy in patients with local advanced breast cancer.
Timeline
- Start
- 2013-06
- Primary completion
- 2013-10
- Completion
- 2018-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | S-1 | Small molecule | 40 mg/m2 | — |
| Comparator | fluorouracil | Small molecule | 500 mg/m2 | Other |