Overview

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