KCT0000674招募中未知
Phase II randomized study of neoadjuvant METformin plus letrozole vs placebo plus letrozole for ER-positive pOstmenopausal bReast cancer
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 208
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 80(Year)（—）
- 性别
- Female
入选标准
- •1)ER-positive =10% nuclear staining by immunohistochemistry , Allred score=3
- •2)T stage II or III
- •3)no distant metastasis
- •4)lower than 80years old, menopausal status (over 60 years old, or bilateral oophorectomy state, or if less than 60 years old, no mensturation during last 1 year and FSH higher than 30mIU/mL)
- •5)ECOG score 0-2
- •6)good functioning myeloid (Hemoglobin >10 g/dL, ANC >1,500/mm3, platelet >100,000/mm3)
- •7)serum Cr <=1.4 mg/dL
- •8)liver function (bilirubin=1.5*upper normal limit, AST/ALT=1.8*upper normal limit, ALP=1.8*upper normal limit)
- •9)the person who participate in this clinical trial himself and had written informed consent
排除标准
- •1)not measurable primary tumor clinically
- •2)N3 or T4
- •3)confirmed distant metastasis
- •4)the patient who have other cancers or not have been 5years after the treatment of other cancer
- •5)uncontrollable infectious disease
- •6)psychotic disorder or epilepsy
- •7)male breast cancer
- •8)poor general condition unable to understand or submit informed consent
- •9)diabetes mellitus (HbA1c=6.5 or FBS=126mg/dL)
- •10)hypersensitivity or intolerance to metformin
- •11)high risk patients for lactic acidosis associated with metformin
- •- congestive heart disease (New York Heart Association (NYHA) Class
- •llll/IV grade)
- •- past medical history of acidosis
- •- habitus alcoholics
- •12)current user of metformin, sulfonylureas, thiazolidenediones, insulin
- •13)diffuse microcalcification on mammography
- •14)multicentric, bilateral or inflammatory breast cancer
- •15)contralateral breast cancer who had chemotherapy or anti-hormonal therapy in 2 years
研究者
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