The Use of Metformin in Early Breast Cancer Patients Pre-Surgery

NCT ID: NCT01302002

Last Updated: 2016-02-23

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

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2016-02-29

Brief Summary

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The study will test metformin in patients with early breast cancer. Blood and tissue will be collected before and after the use of metformin.

Detailed Description

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Patients will take metformin twice a day for 3 weeks before surgery. The hypothesis is that metformin will reduce cell proliferation rates (Ki67) and increase apoptoses (TUNEL)in tumor tissue.

The study will collect and analyze pre- and post-treatment blood specimens for:

* Serum glucose
* Insulin levels
* Estradiol
* HOMA test
* Glycosylated haemoglobin

Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Metformin Pre-Surgery

Patients will take metformin twice a day for three weeks prior surgery

Group Type EXPERIMENTAL

Metformin Pre-Surgery

Intervention Type DRUG

500 mg tablet, taken twice a day for 3 weeks

Interventions

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Metformin Pre-Surgery

500 mg tablet, taken twice a day for 3 weeks

Intervention Type DRUG

Other Intervention Names

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Laboratory biomarker analysis Blood and tissue collection

Eligibility Criteria

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Inclusion Criteria

* Invasive breast cancer T1 or T2, Nx
* Knowledge of the investigational nature of the study and ability to provide consent for study participation

Exclusion Criteria

* Diabetes or baseline glucose or Glycosylated haemoglobin upper limit of normal for the institution
* Recent use of corticosteroids
* AST \> 1.5 times upper limit of normal for the institution
* Pregnancy
* Serious clinical illness
* Prior or concurrent systemic neoadjuvant Breast Cancer therapy.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Instituto Nacional de Cancer, Brazil

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ana Elisa Lohmann

Medical Oncologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ana Elisa Lohmann, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Cancer

Locations

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Hospital do Cancer III

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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INCA113/10

Identifier Type: -

Identifier Source: org_study_id

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