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Toremifene 60 mg daily with metformin 850 mg BID

Toremifene 60 mg daily with melatonin 3 mg before sleep daily

metformin

Tatiana Y Semiglazova, MD, PhD, DSc

Petr V Krivorotko, MD, PhD, DSc

Vladimir F Semiglazov, MD,PhD, DSc, Professor

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.

Neoadjuvant Toremifene With Melatonin or Metformin in Locally Advanced Breast Cancer

Phase II Multicenter Randomized Study to Compare Neoadjuvant Toremifene With Melatonin or Metformin Versus Toremifene in the Therapy of Locally Advanced Breast

Response will evaluate by RECIST criteria

Pathomorphological response will assess after surgery by Miller and Payne Scale

Incidence of AE classified using NCI Common Terminology Criteria for AE v4

N.N. Petrov National Medical Research Center of Oncology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Neoadjuvant Toremifene With Melatonin or Metformin in Locally Advanced Breast Cancer	NCT02506790	Breast Cancer	metformin Melatonin Toremifene	18 Years -	N.N. Petrov National Medical Research Center of Oncology
Neoadjuvant Toremifene With Melatonin or Metformin in Locally Advanced Breast Cancer	NCT02506790	Breast Cancer	metformin Melatonin Toremifene	18 Years -	N.N. Petrov National Medical Research Center of Oncology

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