Neoadjuvant Toremifene With Melatonin or Metformin in 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

NCT02506790
MBC 2
  • Ages > 18
  • Female

Study Summary

This study evaluates the addition melatonin and metformin to toremifene in the treatment of locally advanced breast cancer. Third of patients will receive toremifene, other third will receive combination of melatonin and toremifene and other patients will receive combination of metformin and toremifene.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age > 18.

  • Obtained Inform Concent.

  • Morphologically confirmed breast cancer stage IIB, IIIA, IIIB, IIIC ER positive.

  • Eastern Collaborative Oncology Group Performance Status Scale 0-2.

  • Expected survival > 6 month.

  • Adequate liver and bone marrow function.

Exclusion

Exclusion Criteria:

  • Systemic treatment for breast cancer.

  • Stage IV 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 investigators opinion.

Study Design

Total Participants: 96
Study Start date:
July 01, 2015
Estimated Completion Date:
August 31, 2022

Study Description

The management of locally advanced breast cancer is complicated issue. Neoadjuvant treatment is often needed to downstage locally advanced ER positive BC tumors prior to surgery. However, many patients do not achieved objective response on 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 anti - estrogen treatment may increase objective response. But, this data is still controversial. We hypothesizes that the combinations of melatonin and metformin with conventional anti - estrogen such as toremifene could be more effective than toremifene 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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