drugset / Trial / NCT02897700
A Randomized Trial of Chemotherapy in Surgical Patients With Infiltrating Ductal Carcinoma of Breast
Phase 1
Recruiting
300 enrolled
Shanghai Jiao Tong University School of Medicine
China-Japan Union Hospital, Jilin University · collabGanzhou City People's Hospital · collabShanghai 10th People's Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The overarching purpose of this study is to determine if the mainstay chemotherapeutic regimens represented by several genotoxic agents including but not limited to Cyclophosphamide, Doxorubicin, Epirubicin, Fluorouracil and Methotrexate (CDEFM), in the format of either a single agent or combinations are safe, tolerable, and effective in the treatment of patients with infiltrating ductal carcinoma of breast.
Timeline
- Start
- 2013-01
- Primary completion
- 2026-12
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 100 mg/m2 | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 60 mg/m2 | Intravenous |
| Subject | Epirubicin | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Methotrexate | Small molecule | 50 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 500 mg/m2 | Intravenous |