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

Instituto Nacional de Cancer, Brazil

Status and phase: Withdrawn; Early Phase 1

Conditions: Breast Cancer

Treatments: Drug: Metformin Pre-Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01302002

INCA113/10

Details and patient eligibility

About

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

Full 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

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Metformin Pre-Surgery

Experimental group

Description:

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

Treatment:

Drug: Metformin Pre-Surgery