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

Early Phase 1WithdrawnNCT01302002

Instituto Nacional de Cancer, Brazil

Overview

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

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

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Conditions

Breast Cancer

Interventions

Metformin Pre-SurgeryDRUG

500 mg tablet, taken twice a day for 3 weeks

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital do Cancer III

Rio de Janeiro, Rio de Janeiro, Brazil

Outcomes

Primary Outcomes

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(+).

Time frame: 60 days after the surgery

Secondary Outcomes

To analyse gastrointestinal toxicity

* 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

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

Time frame: 5 days after blood collection

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.