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

NCT02506777 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2019-09-04

No results posted yet for this study

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.

Conditions

Interventions

DRUG

metformin

DRUG

Fluoruracil

DRUG

Doxorubicin

DRUG

Cyclophosphamide

DRUG

melatonin

Sponsors & Collaborators

  • N.N. Petrov National Medical Research Center of Oncology

    lead OTHER

Principal Investigators

  • Vladimir F Semiglazov, MD, PhD, DSc, Professor · N.N. Petrov Research Institute of Oncology

  • Tatiana Y Semiglazova · N.N. Petrov Research Institute of Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • Russia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02506777 on ClinicalTrials.gov