Neoadjuvant FDC With Melatonin or Metformin for Locally Advanced Breast Cancer. — MBC1  

Breast Cancer Clinical Trial

Official title: Phase II Multicenter Randomized Study to Compare Neoadjuvant FDC With Melatonin or Metformin Versus FDC Alone in The Therapy of Locally Advanced Breast Cancer.

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT02506777
• Study type: Interventional
• Source: N.N. Petrov National Medical Research Center of Oncology
• Contact: Tatiana Y Semiglazova, MD, PhD, DSc
• Phone: +79219468072
• Email: tsemiglazova@mail.ru
• Status: Recruiting
• Phase: Phase 2
• Start date: July 2015
• Completion date: August 2020