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

Early Phase 1

Withdrawn

• Conditions: Breast Cancer
• Interventions: Drug: Metformin Pre-Surgery

• Registration Number: NCT01302002
• Lead Sponsor: Instituto Nacional de Cancer, Brazil

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

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-14
• Study First Submitted QC: 2011-02-22
• Study First Posted: 2011-02-23
• Status Verified: 2016-02
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Last Update Submitted: 2016-02-22
• Last Update Posted: 2016-02-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metformin Pre-Surgery	Metformin Pre-Surgery	Patients will take metformin twice a day for three weeks prior surgery

Primary Outcome Measures

Name	Time	Method
To determine the in situ effects of metformin in women with operable stage I or II breast cancer	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(+).

Secondary Outcome Measures

Name	Time	Method
To analyse gastrointestinal toxicity	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
To analyse the blood tests one day before the biopsy and one day before the surgery	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

Trial Locations

Locations (1)

Hospital do Cancer III; 🇧🇷 Rio de Janeiro, Brazil