Breast Cancer
Conditions
Keywords
Melatonin, metformin, chemotherapy
Brief 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.
Detailed description
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.
Interventions
Sponsors
N.N. Petrov National Medical Research Center of Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18. Obtained Inform Consent Morphologically confirmed breast cancer stage IIB, IIIA,IIIB,IIIC. ( triple negative, luminal B) Eastern Collaborative Oncology Group Performance Status Scale 0 - 2. Expected survival \>6 month Adequate liver and bone marrow function
Exclusion criteria
* Systemic treatment for breast cancer IV stage disease Evidence of liver and bone marrow clinically meaningful disfunction Severe uncontrolled concomitant conditions and diseases Pregnancy or lactation Second malignancy Diabetes mellitus requiring drug therapy Any condition preventing study participation by investigator opinion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | 6 months after FPFV | Response will evaluate by RECIST criteria |
| Pathomorphological response | 6 months after FPFV | Pathomorphological response will assess after surgery by Miller and Payne Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events incidence | Until 30 days after last patient treatment visit | Incidence of AE classified using NCI Common Terminology Criteria for AE v4 |
Countries
Russia
Contacts
Primary ContactTatiana Y Semiglazova, MD, PhD, DSc
Outcome results
None listed