NCT01302002

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2011

Longer than P75 for early_phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 14, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 23, 2011

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

5.1 years

First QC Date

February 14, 2011

Last Update Submit

February 22, 2016

Conditions

Breast Cancer

Keywords

Breast CancerMetforminPre-Surgery

Outcome Measures

Primary Outcomes (1)

  • To determine the in situ effects of metformin in women with operable stage I or II breast cancer

    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 Outcomes (2)

  • To analyse gastrointestinal toxicity

    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

    5 days after blood collection

Study Arms (1)

Metformin Pre-Surgery

EXPERIMENTAL

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

Drug: Metformin Pre-Surgery

Interventions

Metformin Pre-SurgeryDRUG

500 mg tablet, taken twice a day for 3 weeks

Also known as: Laboratory biomarker analysis, Blood and tissue collection
Metformin Pre-Surgery

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital do Cancer III

Rio de Janeiro, Rio de Janeiro, 20560-120, Brazil

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Blood Specimen CollectionTissue Banks

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesBiological Specimen BanksHealth FacilitiesHealth Care Facilities Workforce and Services

Study Officials

  • Ana Elisa Lohmann, MD

    Instituto Nacional de Cancer

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Oncologist

Study Record Dates

First Submitted

February 14, 2011

First Posted

February 23, 2011

Study Start

January 1, 2011

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

February 23, 2016

Record last verified: 2016-02

Locations

BR(1)