Breast cancer patients candidates to surgical treatment not suitable for neoadjuvant therapy. MedDRA version: 9.1 Level: PT Classification code 10057654 Term: Breast cancer female
Conditions
Interventions
Trade Name: METFORAL*30CPR RIV 850MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Metformin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 850-
Pharmaceutical
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed