The Use of Metformin in Early Breast Cancer Patients Pre-Surgery: A Phase 0 Study Regarding The Biological Effect
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- To determine the in situ effects of metformin in women with operable stage I or II breast cancer
研究概览
简要总结
The study will test metformin in patients with early breast cancer. Blood and tissue will be collected before and after the use of metformin.
详细描述
Patients will take metformin twice a day for 3 weeks before surgery. The hypothesis is that metformin will reduce cell proliferation rates (Ki67) and increase apoptoses (TUNEL)in tumor tissue.
The study will collect and analyze pre- and post-treatment blood specimens for:
- Serum glucose
- Insulin levels
- Estradiol
- HOMA test
- Glycosylated haemoglobin
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Invasive breast cancer T1 or T2, Nx
- •Knowledge of the investigational nature of the study and ability to provide consent for study participation
排除标准
- •Diabetes or baseline glucose or Glycosylated haemoglobin upper limit of normal for the institution
- •Recent use of corticosteroids
- •AST > 1.5 times upper limit of normal for the institution
- •Pregnancy
- •Serious clinical illness
- •Prior or concurrent systemic neoadjuvant Breast Cancer therapy.
研究组 & 干预措施
Metformin Pre-Surgery
Patients will take metformin twice a day for three weeks prior surgery
干预措施: Metformin Pre-Surgery (Drug)
结局指标
主要结局
To determine the in situ effects of metformin in women with operable stage I or II breast cancer
时间窗: 60 days after the surgery
To determine the in situ effects of metformin on * proliferation (Ki67) and apoptosis (TUNEL), fosforilate AKT * CD1a CD83, CD68, F40/80, arginase iNOS and T cells -CD4(+),CD45RA(+), CD 45RO, CD4, CD8 and FOXP3(+).
次要结局
- To analyse gastrointestinal toxicity(One week , 2 weeks and 20 days after Metformim beginning)
- To analyse the blood tests one day before the biopsy and one day before the surgery(5 days after blood collection)
研究者
Ana Elisa Lohmann
Medical Oncologist
Instituto Nacional de Cancer, Brazil