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

February 22, 2016 updated by: Ana Elisa Lohmann, Instituto Nacional de Cancer, Brazil

The Use of Metformin in Early Breast Cancer Patients Pre-Surgery: A Phase 0 Study Regarding The Biological Effect

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 20560-120
        • Hospital do Cancer III

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metformin Pre-Surgery
Patients will take metformin twice a day for three weeks prior surgery
Drug: Metformin Pre-Surgery
500 mg tablet, taken twice a day for 3 weeks
Other Names:
  • Laboratory biomarker analysis
  • Blood and tissue collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the in situ effects of metformin in women with operable stage I or II breast cancer
Time Frame: 60 days after the surgery

To determine the in situ effects of metformin on

  • proliferation (Ki67) and apoptosis (TUNEL), fosforilate AKT
  • CD1a CD83, CD68, F40/80, arginase iNOS and T cells -CD4(+),CD45RA(+), CD 45RO, CD4, CD8 and FOXP3(+).
60 days after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To analyse gastrointestinal toxicity
Time Frame: One week , 2 weeks and 20 days after Metformim beginning
  • To analyse gastrointestinal toxicity grade (examples: nausea, stomach pain, vomiting)
  • Number of Participants with Adverse Events
One week , 2 weeks and 20 days after Metformim beginning
To analyse the blood tests one day before the biopsy and one day before the surgery
Time Frame: 5 days after blood collection
-To collect and analyze pre- and post-treatment peripheral blood specimens for serum glucose, glycosylated haemoglobin and insulin levels, as well as circulating IGF-1 and estradiol
5 days after blood collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cancer, Brazil

Investigators

  • Principal Investigator: Ana Elisa Lohmann, MD, Instituto Nacional de Câncer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

February 14, 2011

First Submitted That Met QC Criteria

February 22, 2011

First Posted (Estimate)

February 23, 2011

Study Record Updates

Last Update Posted (Estimate)

February 23, 2016

Last Update Submitted That Met QC Criteria

February 22, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCA113/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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