Breast cancer chemoprevention
Conditions
Interventions
Trade Name: METFORMINA TEVA
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Metformin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 850-
Pharmaceutical fo
Sponsors
ISTITUTI FISIOTERAPICI OSPITALIERI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Written Informed Consent; 2) Willingness to be randomized; 3) Postmenopausal status (defined as women with no menstrual period for at least 12 months before enrollment in the study); 4) Age 45 to 74; 5) Willingness to provide blood and urine samples; 6) Willingness and capability to be followed for five years; 7) Presence of central obesity, as defined based on a waist circumference ≥ than 80 cm, AND at least one metabolic syndrome component among those reported below: high plasma levels of glucose (≥100 mg/100 mL) high levels of triglycerides (≥150mg/100mL) or specific treatment for this lipid abnormality low levels of HDL cholesterol (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Subjects not meeting each of the above criteria; 2) previous history of malignancies (any but non melanoma-skin cancer); 3) mammograms reporting images of suspected lesions (participants might have undergone the mammogram at the study entrance or within the previous 12 months); 4) type 1 and 2 diabetes; 5) history of coronary artery disease, history of myocardial infarction, heart failure, stroke; 6) kidney failure 7) chronic hepatitis (in treatment); 8) serum creatinine >124 μmol/L 9) presence of proteinuria (defined as more than trace positive) 10) Age older than 74
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The first aim of this application is to conduct a blinded, randomized, placebo controlled trial (RCT) to investigate the effect of metformin on breast cancer occurrence during a five year follow-up. The study will be conducted on postmenopausal women, 45-74 years of age. Besides age, women included in the study will be at high risk of breast cancer because of a waist circumference equal to or greater than (≥) 80 centimeters (cm) and the presence of at least another component of metabolic syndrome (MS). Metformin is an antidiabetic drug widely given to patients with chronic conditions etiologically related to breast cancer (type 2 diabetes, elevated levels of androgens and estrogens, impaired glucose metabolism). The study hypothesis is that study participants treated with metformin will have a lower incidence of breast cancer in comparison with women given placebo on breast cancer prevention during a 5-year follow-up.;Secondary Objective: The second aim of this randomized clinical trial (RCT) focuses on the effect of metformin on the incidence of cardiovascular diseases (CVDs) including heart disease and stroke. Because CVDs are the leading cause of death in postmenopausal women and because breast cancer and cardiovascular diseases share several important risk factors, including type 2 diabetes and impaired glucose metabolism, the proposed study will target CVD prevention as the secondary aim. The study hypothesis is that study participants treated with metformin will show a lower incidence of cardiovascular diseases in comparison with women given placebo and healthy lifestyle information during a 5 year follow-up. The third aim of this application is to develop a biorepository of blood samples, collected at three time points (before randomization, mid-term, at the end of the study period). This will create a large biological database for future research;Primary end point(s): Breast cancer incidence | — |
Countries
Italy
Outcome results
None listed