Neoadjuvant Toremifene With Melatonin or Metformin in Locally Advanced Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2022-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Toremifene and metformin

Toremifene 60 mg daily with metformin 850 mg BID

Group Type EXPERIMENTAL

metformin

Intervention Type DRUG

Toremifene

Intervention Type DRUG

Toremifene and melatonin

Toremifene 60 mg daily with melatonin 3 mg before sleep daily

Group Type EXPERIMENTAL

Melatonin

Intervention Type DRUG

Toremifene

Intervention Type DRUG

Toremifene

Toremifene 60 mg daily

Group Type ACTIVE_COMPARATOR

Toremifene

Intervention Type DRUG

Interventions

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metformin

Intervention Type DRUG

Melatonin

Intervention Type DRUG

Toremifene

Intervention Type DRUG

Other Intervention Names

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siofor 850 melaxen farestone

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No