The Effect of Metformin, an insulin-sensitizing drug, on Breast Cancer Primary Prevention: The Plotina Breast Cancer Prevention Randomized, Placebo Controlled Trial - PLOTINA

• Conditions: Breast cancer chemoprevention

• Registration Number: EUCTR2009-009921-28-IT
• Lead Sponsor: ISTITUTI FISIOTERAPICI OSPITALIERI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-04
• Last Update Posted: 2 October 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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 (<50 mg/100mL) or specific treatment for this lipid abnormality hypertension (Systolic Blood Pressure≥130 mm Hg or Diastolic Blood Pressure ≥85 mm Hg) or treatment of previously diagnosed hypertension
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified