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

Last updated: September 2, 2019
Sponsor: N.N. Petrov National Medical Research Center of Oncology
Overall Status: Active - Recruiting

Phase

2

Condition

Breast Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT02506777
MBC1
  • Ages > 18
  • Female

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age >18. Obtained Inform Consent Morphologically confirmed breast cancer stage IIB,IIIA,IIIB,IIIC. ( triple negative, luminal B) Eastern Collaborative Oncology GroupPerformance Status Scale 0 - 2. Expected survival >6 month Adequate liver and bonemarrow function

Exclusion

Exclusion Criteria:

  • Systemic treatment for breast cancer IV stage disease Evidence of liver and bonemarrow clinically meaningful disfunction Severe uncontrolled concomitant conditionsand diseases Pregnancy or lactation Second malignancy Diabetes mellitus requiring drugtherapy Any condition preventing study participation by investigator opinion

Study Design

Total Participants: 96
Study Start date:
July 01, 2015
Estimated Completion Date:
August 31, 2020

Study 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.

Connect with a study center

  • N.N. Petrov Research Institute of Oncology Clinical Diagnostic Department

    Saint - Petersburg, 191124
    Russian Federation

    Active - Recruiting

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