Preventing Breast cancer through Assumption of Metformin, Diet and Physical Activity - Bremet Diet

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-006527-30-IT

Enrollment

16000

Registered

2009-03-10

Start date

2008-12-17

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

women affected by metabolic syndrome defined by at least three out of five metabolic factors: 1-glucose >110 mg/100 mL 2-triglycerides >150mg/100mL 3-HDL cholesterol 88 cm) 5-hypertension SBP>130 mm Hg or DBP >85 mm H MedDRA version: 9.1 Level: SOC Classification code 10038604 MedDRA version: 9.1 Level: SOC Classification code 10029104 MedDRA version: 9.1 Level: PT Classification code 10007649 MedDRA version: 9.1 Level: SOC Classification code 10022891

Interventions

Trade Name: METFORMINA TEVA Pharmaceutical Form: Tablet INN or Proposed INN: Metformin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 850- Pharmaceutical form of t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: A)Women aged 40 year or more B)women affected by metabolic syndrome defined by at least three out of five metabolic factors: 1-glucose >110 mg/100 mL 2-triglycerides >150mg/100mL 3-HDL cholesterol 88 cm) 5-hypertension SBP>130 mm Hg or DBP >85 mm Hg C)high mammographic breast density. D)high risk score based on classical non modifiable risk factors (family history, nulliparity or late pregnancy, early menarche, late menopause, etc) 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

Exclusion criteria: A) age<40 years

Design outcomes

Primary

Measure	Time frame
Main Objective: whether the assumption of Metformin,a combined lifestyle intervention aimed at promoting moderate physical activity, reducing or controlling body weight, and improving diet, will result in a significantly reduced breast cancer incidence in high risk women.;Secondary Objective: the effect of the Metformin administration and lifestyle changes on total cancer incidence and all-cause mortality;Primary end point(s): incidence of breast cancer in patients with high risk profile.	—

Measure

Time frame

Main Objective: whether the assumption of Metformin,a combined lifestyle intervention aimed at promoting moderate physical activity, reducing or controlling body weight, and improving diet, will result in a significantly reduced breast cancer incidence in high risk women.;Secondary Objective: the effect of the Metformin administration and lifestyle changes on total cancer incidence and all-cause mortality;Primary end point(s): incidence of breast cancer in patients with high risk profile.

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026