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

ISTITUTO EUROPEO DI ONCOLOGIA0 个研究点开始时间: 2008年11月20日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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

•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.

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