Neoadjuvant FDC With Melatonin or Metformin for 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

2020-08-31

Brief Summary

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This study evaluates the addition melatonin and metformin to conventional chemotherapy FDC (Fluoruracil, Doxorubicin, cyclophosphamide) in the treatment of locally advanced breast cancer. Third of patients will receive FDCх6 cycles, other third will receive combination of melatonin and FDCх6 cycles and other patients will receive combination of metformin and FDCх6 cycles.

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Detailed Description

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The treatment of locally advanced breast cancer is a complicated issue. For neoadjuvant treatment is often needed to downstage locally advanced BC tumors prior to surgery, however many patients do not achieved objective response during 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 treatment may increase objective response. But, this data is still controversial. We hypothesized that combinations of melatonin and conventional chemotherapy regimen such as FDC could be more effective than FDC 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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FDC x 6 cycles with metformin

32 patients will receive 5 - Fluoruracil 500 mg/m\^2, doxorubicin 50 mg/m\^2, cyclophosphamide 500 mg/m\^2 once every 21 days with metformin 850 mg BID

Group Type EXPERIMENTAL

metformin

Intervention Type DRUG

Fluoruracil

Intervention Type DRUG

Doxorubicin

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

FDC x 6 cycles with melatonin

32 patients will receive 5 - Fluoruracil 500 mg/m\^2, doxorubicin 50 mg/m\^2, cyclophosphamide 500 mg/m\^2 once every 21 days with melatonin 3 mg before sleep daily

Group Type EXPERIMENTAL

Fluoruracil

Intervention Type DRUG

Doxorubicin

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

melatonin

Intervention Type DRUG

FDC x 6 cycles

32 patients will receive 5 - Fluoruracil 500 mg/m\^2, doxorubicin 50 mg/m\^2, cyclophosphamide 500 mg/m\^2 once every 21 days

Group Type ACTIVE_COMPARATOR

Fluoruracil

Intervention Type DRUG

Doxorubicin

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Interventions

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metformin

Intervention Type DRUG

Fluoruracil

Intervention Type DRUG

Doxorubicin

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

melatonin

Intervention Type DRUG

Other Intervention Names

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siofor 850 Adriablastin endoxan melaxen

Eligibility Criteria

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Inclusion Criteria

* Age \>18. Obtained Inform Consent Morphologically confirmed breast cancer stage IIB, IIIA,IIIB,IIIC. ( triple negative, luminal B) 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 IV stage 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 investigator opinion

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No