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

Primary Purpose

Breast Cancer

Status

Withdrawn

Phase

Early Phase 1

Locations

Brazil

Study Type

Interventional

Intervention

Metformin Pre-Surgery

About this trial

This is an interventional basic science trial for Breast Cancer focused on measuring Breast Cancer, Metformin, Pre-Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Hospital do Cancer III

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Metformin Pre-Surgery

Arm Description

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

Outcomes

Primary Outcome Measures

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(+).

Secondary Outcome Measures

To analyse gastrointestinal toxicity

To analyse gastrointestinal toxicity grade (examples: nausea, stomach pain, vomiting) Number of Participants with Adverse Events

To analyse the blood tests one day before the biopsy and one day before the surgery

-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

Full Information

NCT ID

NCT01302002

First Posted

February 14, 2011

Last Updated

February 22, 2016

Sponsor

Instituto Nacional de Cancer, Brazil

1. Study Identification

Unique Protocol Identification Number

NCT01302002

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Withdrawn

Study Start Date

January 2011 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Instituto Nacional de Cancer, Brazil

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Breast Cancer, Metformin, Pre-Surgery

7. Study Design

Primary Purpose

Basic Science

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Metformin Pre-Surgery

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Metformin Pre-Surgery

Other Intervention Name(s)

Laboratory biomarker analysis, Blood and tissue collection

Intervention Description

500 mg tablet, taken twice a day for 3 weeks

Primary Outcome Measure Information:

Title

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

Description

Time Frame

60 days after the surgery

Secondary Outcome Measure Information:

Title

To analyse gastrointestinal toxicity

Description

To analyse gastrointestinal toxicity grade (examples: nausea, stomach pain, vomiting) Number of Participants with Adverse Events

Time Frame

One week , 2 weeks and 20 days after Metformim beginning

Title

To analyse the blood tests one day before the biopsy and one day before the surgery

Description

-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

Time Frame

5 days after blood collection

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ana Elisa Lohmann, MD

Organizational Affiliation

Instituto Nacional de Cancer

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital do Cancer III

City

Rio de Janeiro

ZIP/Postal Code

20560-120

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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