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.
The treatment of locally advanced breast cancer is a complicated issue. For neoadjuvant treatment is often needed to downstage locally advanced BC tumors prior to surgery, however many patients do not achieved objective response during treatment. The ability of melatonin and metformin to decrease side effects of chemotherapy had been investigated, moreover several studies confirm, that this drugs in combination with conventional treatment may increase objective response. But, this data is still controversial. We hypothesized that combinations of melatonin and conventional chemotherapy regimen such as FDC could be more effective than FDC alone in terms of response rate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
N.N. Petrov Research Institute of Oncology Clinical Diagnostic Department
Saint Petersburg, Russia
RECRUITINGResponse rate
Response will evaluate by RECIST criteria
Time frame: 6 months after FPFV
Pathomorphological response
Pathomorphological response will assess after surgery by Miller and Payne Scale
Time frame: 6 months after FPFV
Adverse events incidence
Incidence of AE classified using NCI Common Terminology Criteria for AE v4
Time frame: Until 30 days after last patient treatment visit
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