drugset / Trial / NCT02506777
Neoadjuvant FDC With Melatonin or Metformin for Locally Advanced Breast Cancer.
RandomizedParallel-groupOpen-labelTreatment
Summary
This study evaluates the addition melatonin and metformin to conventional chemotherapy FDC (Fluoruracil, Doxorubicin, cyclophosphamide) in the treatment of locally advanced breast cancer. Third of patients will receive FDCх6 cycles, other third will receive combination of melatonin and FDCх6 cycles and other patients will receive combination of metformin and FDCх6 cycles.
Timeline
- Start
- 2015-07
- Primary completion
- 2020-08
- Completion
- 2020-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Melatonin | Small molecule | 3 mg | — |
| Subject | Metformin | Small molecule | 850 mg | — |
| Background | Cyclophosphamide | Other / unclassified | 500 mg/m2 | — |
| Background | Doxorubicin | Other / unclassified | 50 mg/m2 | — |
| Background | Fluoruracil | Unknown | 500 mg/m2 | — |