Neoadjuvant Toremifene With Melatonin or Metformin in Locally Advanced Breast Cancer

  • End date
    Aug 23, 2022
  • participants needed
  • sponsor
    N.N. Petrov National Medical Research Center of Oncology
Updated on 23 January 2021
advanced breast cancer
locally advanced breast cancer
breast cancer staging


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.


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.

Condition Breast Cancer, Breast Cancer Diagnosis, breast carcinoma, cancer, breast
Treatment Metformin, Melatonin, Toremifene
Clinical Study IdentifierNCT02506790
SponsorN.N. Petrov National Medical Research Center of Oncology
Last Modified on23 January 2021


Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you female?
Do you have Breast Cancer?
Do you have any of these conditions: Breast Cancer or Breast Cancer Diagnosis or breast carcinoma or cancer, breast?
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 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
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