Neoadjuvant FDC With Melatonin or Metformin for Locally Advanced Breast Cancer. (MBC1)

N.N. Petrov National Medical Research Center of Oncology

Status and phase: Unknown; Phase 2

Conditions: Breast Cancer

Treatments: Drug: metformin; Drug: melatonin; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Fluoruracil

Study type: Interventional

Funder types: Other

Identifiers

NCT02506777

MBC1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 96 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

FDC x 6 cycles with metformin

Experimental group

Description:

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

Treatment:

Drug: Doxorubicin

Drug: Fluoruracil

Drug: Cyclophosphamide

Drug: metformin

FDC x 6 cycles with melatonin

Experimental group

Description:

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

Treatment:

Drug: Doxorubicin

Drug: Fluoruracil

Drug: Cyclophosphamide

Drug: melatonin

FDC x 6 cycles

Active Comparator group

Description:

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

Treatment:

Drug: Doxorubicin

Drug: Fluoruracil

Drug: Cyclophosphamide