NCT02506777

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

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: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: N.N. Petrov National Medical Research Center of Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	metformin
DRUG	Fluoruracil
DRUG	Doxorubicin
DRUG	Cyclophosphamide
DRUG	melatonin

Timeline

• Start date: 2015-07-01
• Primary completion: 2020-08-01
• Completion: 2020-08-01
• First posted: 2015-07-23
• Last updated: 2019-09-04

Locations

1 site across 1 country: Russia