Evaluation of the Effect of Metformin on Metastatic Breast Cancer as Adjuvant Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
This study aims to determine the effect of metformin along with standard cancer treatment, and its effect on the prognosis of the metastatic breast in non-diabetic patients.
详细描述
the role of metformin when combined with traditional metastatic breast cancer treatment in non-diabetic patients compared to diabetic patients who are not using metformin. In this randomized control study, there will be a demonstration either it is effective to suppress tumor burden or not through normal screening for tumor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The non-diabetic patients will be included in the study if they meet the following criteria:
- •Confirmed metastatic breast cancer (IV stage) radiologically or by clinical evaluation receiving chemotherapy
- •Age between 18- 70 years.
- •Life expectancy at least 6 months
排除标准
- •The patients will be excluded from the study if they have the following criteria:
- •Bad prognosis disease: Criteria defined as the following
- •If patient >70 years
- •If patient has bad site metastasis (brain)
- •Hypersensitivity for metformin: if happened patient will be treated as following
- •Pheniramine Maleate 3 times daily for 7 days and Tablet Dexamethasone 1mg daily in 2 divided doses for 5 days [16].
- •Any condition associated with increased risk of metformin-associated lactic acidosis (e.g., congestive heart failure defined as New York Heart Association {NYHA} Class III or IV functional status; the history of acidosis of any type, severe infections, kidney or liver disease, respiratory disease, seizures .
- •Diabetic patients.
研究组 & 干预措施
Metformin group
Non Diabetic metastatic breast cancer Patients will take metformin 1 gm. twice daily (Nathan 2009) along with standard chemotherapy
干预措施: Metformin plus chemotherapy (Drug)
control group
Non Diabetic metastatic breast cancer Patients will take standard chemotherapy only
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: 6 months
the time period from the start of trial till death or end of follow-up
Progression-free survival
时间窗: 6 months
from the time between start of the trial and recurrence or disease progression, or end of follow-up
The radiologic response rate
时间窗: 3 months
The Response Evaluation Criteria in Solid Tumors (RECIST 1.1) was used to evaluate the response to chemotherapy alone in case of control arm and chemotherapy plus metformin in case of drug arm for breast cancer with distant metastasis
次要结局
- Insulin Growth like Factor -1 (IGF-1) at base line and after 3 cycle.(3 months)
研究者
Hager salah el din
pharmacist
Beni-Suef University