Phase II Multicenter Randomized Study to Compare Neoadjuvant Toremifene With Melatonin or Metformin Versus Toremifene in the Therapy of Locally Advanced Breast
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
This study evaluates the addition melatonin and metformin to toremifene in the treatment of locally advanced breast cancer. Third of patients will receive toremifene, other third will receive combination of melatonin and toremifene and other patients will receive combination of metformin and toremifene.
详细描述
The management of locally advanced breast cancer is complicated issue. Neoadjuvant treatment is often needed to downstage locally advanced ER positive BC tumors prior to surgery. However, many patients do not achieved objective response on treatment. The ability of melatonin and metformin to decrease side effects of chemotherapy had been investigated, moreover, several studies confirm, that this drugs in combination with conventional anti - estrogen treatment may increase objective response. But, this data is still controversial. We hypothesizes that the combinations of melatonin and metformin with conventional anti - estrogen such as toremifene could be more effective than toremifene alone in terms of response rate.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Obtained Inform Concent.
- •Morphologically confirmed breast cancer stage IIB, IIIA, IIIB, IIIC ER positive.
- •Eastern Collaborative Oncology Group Performance Status Scale 0-
- •Expected survival > 6 month.
- •Adequate liver and bone marrow function.
排除标准
- •Systemic treatment for breast cancer.
- •Stage IV disease.
- •Evidence of liver and bone marrow clinically meaningful disfunction.
- •Severe uncontrolled concomitant conditions and diseases.
- •Pregnancy or lactation.
- •Second malignancy.
- •Diabetes mellitus requiring drug therapy.
- •Any condition preventing study participation by investigators opinion.
研究组 & 干预措施
Toremifene and metformin
Toremifene 60 mg daily with metformin 850 mg BID
干预措施: metformin (Drug)
Toremifene and metformin
Toremifene 60 mg daily with metformin 850 mg BID
干预措施: Toremifene (Drug)
Toremifene and melatonin
Toremifene 60 mg daily with melatonin 3 mg before sleep daily
干预措施: Melatonin (Drug)
Toremifene and melatonin
Toremifene 60 mg daily with melatonin 3 mg before sleep daily
干预措施: Toremifene (Drug)
Toremifene
Toremifene 60 mg daily
干预措施: Toremifene (Drug)
结局指标
主要结局
Response rate
时间窗: 4 months after FPFV
Response will evaluate by RECIST criteria
Pathomorphological response
时间窗: 4 months after FPFV
Pathomorphological response will assess after surgery by Miller and Payne Scale
次要结局
- Adverse events incidence(Until 30 days after last patient treatment visit)