Effect of metformin in overweight breast cancer survivors at increased risk of recurrence

¿A randomized placebo controlled phase II study with metformin in metabolic-unbalanced breast cancer survivors at higher risk for recurrence (MetBreCS)¿ - MetBreCS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001001-14-IT

Enrollment

236

Registered

2021-01-26

Start date

2015-10-07

Completion date

Unknown

Last updated

2024-03-12

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

Conditions

Metabolic-unbalanced breast cancer survivors at higher risk for recurrence (triple negative breast cancer, luminal B Her2 positive, non luminal HER2 positive) MedDRA version: 20.0 Level: LLT Classification code 10006190 Term: Breast cancer invasive NOS System Organ Class: 100000004864

Interventions

Trade Name: METFORAL - 850 MG COMPRESSE RIVESTITE CON FILM 30 COMPRESSE Pharmaceutical Form: Coated tablet Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Ora

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Pre- and postmenopausal BC survivors (TN, or ER neg PgR neg Her2 pos, or Luminal B Her2 pos subtypes) who have completed any adjuvant therapy (not before 1 month from treatment cessation) without evidence of residual disease and with BMI > 25 kg/m2 • Female, (age > 18 years). • Performance status = 0 (SWOG). 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 166 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70

Exclusion criteria

Exclusion criteria: • Diabetic patients • Concomitant use of metformin • Bilateral breast cancer

Design outcomes

Primary

Measure	Time frame
Main Objective: Metformin, given for 1 year, may decrease breast epithelial cells proliferation also in disease-free, metabolic unbalanced BC survivors.;Secondary Objective: The secondary endpoints include a series of analyses and biomarkers evaluations, i.e. the metformin effect on circulating serum biomarkers obtained by morning fasting blood samples and associated to insulin resistance and inflammatory condition (IGF-I, IGFBP-3, IGFBP-1, insulin, HOMA, lipid profile, SHBG, adiponectin and leptin, steroids, high sensitive-CRP) and molecular biomarkers (DNA epigenome-transcriptome analyses). Moreover, we will validate the metformin anticancer-action pathways and we will perform a series of targeted and untargeted metabolomics analyses. Finally, safety and toxicity of the drug will be considered as additional secondary endpoints.;Primary end point(s): change of Ki-67 in contralateral unaffected breast;Timepoint(s) of evaluation of this end point: The analysis on the primary endpoint will be performed at the end of the completion of the 12 month treatment period for all participants.	—

Measure

Time frame

Main Objective: Metformin, given for 1 year, may decrease breast epithelial cells proliferation also in disease-free, metabolic unbalanced BC survivors.;Secondary Objective: The secondary endpoints include a series of analyses and biomarkers evaluations, i.e. the metformin effect on circulating serum biomarkers obtained by morning fasting blood samples and associated to insulin resistance and inflammatory condition (IGF-I, IGFBP-3, IGFBP-1, insulin, HOMA, lipid profile, SHBG, adiponectin and leptin, steroids, high sensitive-CRP) and molecular biomarkers (DNA epigenome-transcriptome analyses). Moreover, we will validate the metformin anticancer-action pathways and we will perform a series of targeted and untargeted metabolomics analyses. Finally, safety and toxicity of the drug will be considered as additional secondary endpoints.;Primary end point(s): change of Ki-67 in contralateral unaffected breast;Timepoint(s) of evaluation of this end point: The analysis on the primary endpoint will be performed at the end of the completion of the 12 month treatment period for all participants.

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Secondary

Measure	Time frame
Secondary end point(s): To check the ability of the treatment to modulate various translational risk factors related to the target tissue and the host characteristics ¿ circulating and molecular biomarkers ¿ metabolomic analysis ¿ gene expression profile in adipose and epithelial breast tissue ¿ assessment of epigenetic changes in methylome patterns (DNA methylation) ;Timepoint(s) of evaluation of this end point: Secondary endpoint analysis will be available at the end of the third year	—

Measure

Time frame

Secondary end point(s): To check the ability of the treatment to modulate various translational risk factors related to the target tissue and the host characteristics ¿ circulating and molecular biomarkers ¿ metabolomic analysis ¿ gene expression profile in adipose and epithelial breast tissue ¿ assessment of epigenetic changes in methylome patterns (DNA methylation) ;Timepoint(s) of evaluation of this end point: Secondary endpoint analysis will be available at the end of the third year

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Countries

Italy

Contacts

Public ContactUfficio Studi Clinici e Attivit¿ Re

Istituto Europeo di Oncologia

ufficio.studiclinici@ieo.it+39 02 57489848

Outcome results

None listed

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