A pre-surgical phase II study on activity of Metformin on breast cancer cells proliferation. - ND

• Conditions: Breast cancer patients candidates to surgical treatment not suitable for neoadjuvant therapy.; MedDRA version: 9.1Level: PTClassification code 10057654Term: Breast cancer female

• Registration Number: EUCTR2008-004912-10-IT
• Lead Sponsor: ISTITUTO EUROPEO DI ONCOLOGIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Female, aged 18 years or older. Performance status = 0 (SWOG). Histologically-confirmed breast cancer, not suitable for neoadjuvant therapy. Stage T1-3, N0-1, Mx No previous treatment for breast cancer. Provision of written informed consent.
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

Previous treatment for breast cancer, including chemotherapy and endocrine therapy. Known severe hypersensitivity to Metformin or any of the excipients of this product. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or in situ cervical cancer. As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) that would prevent subjects from undergoing any of the treatment options or would prevent prolonged follow-up. Diabetes mellitus and diabetes? treatments Creatinine >1.5 mg/dl and/or Glomerular filtration > 60 ml/min/1.73m2 Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study. Pregnancy or breast feeding (women of child-bearing potential must have a negative pregnancy test within 7 days before the start of study treatment and should practice acceptable methods of birth control to prevent pregnancy during and after study treatment). Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: to assess the activity of the drug Metformin on breast cancer cells proliferation in a cohort of patients candidates to primary surgical treatment with non-metastatic breast disease.;Secondary Objective: effect of treatment on tumors with different receptorial asset(ER+ ed ER-) and on other biomarkers apparently involved in the antitumor meccanism of action of the drug (Cicline D1,p53,VEGF).;Primary end point(s): the assessment of Metformin effect, as compared with placebo, on Ki-67 in breast cancer tissue at baseline (by core biopsy) and after 28 days of treatment on the surgical specimen.