Neoadjuvant FDC With Melatonin or Metformin for Locally Advanced Breast Cancer.

• Status: Unknown status
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: N.N. Petrov National Medical Research Center of Oncology; Petrov Research Institute of Oncology
• Treatments: Cyclophosphamide; Doxorubicin; Fluorouracil; Liposomal doxorubicin; Melatonin; Metformin

Criteria

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