Neoadjuvant Toremifene With Melatonin or Metformin in Locally Advanced Breast Cancer

N.N. Petrov National Medical Research Center of Oncology

Status and phase: Unknown; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Melatonin; Drug: Toremifene; Drug: metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT02506790

MBC 2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 3 patient groups

Toremifene and metformin

Experimental group

Description:

Toremifene 60 mg daily with metformin 850 mg BID

Treatment:

Drug: metformin

Drug: Toremifene

Toremifene and melatonin

Experimental group

Description:

Toremifene 60 mg daily with melatonin 3 mg before sleep daily

Treatment:

Drug: Toremifene

Drug: Melatonin

Toremifene

Active Comparator group

Description:

Toremifene 60 mg daily

Treatment:

Drug: Toremifene