Spots Global Cancer Trial Database for Neoadjuvant Toremifene With Melatonin or Metformin in Locally Advanced Breast Cancer

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Trial Identification

Brief Title: Neoadjuvant Toremifene With Melatonin or Metformin in Locally Advanced Breast Cancer

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

Study ID: NCT02506790

Conditions

Breast Cancer

Interventions

metformin

Melatonin

Toremifene

Study Description

Brief 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.

Detailed 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.