ACTRN12612000416897招募中未知
Sequential evaluation of tumours undergoing pre-operative therapy with aromatase inhibitors and metformin (setup-aim) a neo-adjuvant pilot study in operable hormone sensitive breast cancer in post menopausal women
Dr Vinod Ganju0 个研究点目标入组 40 人开始时间: 2012年4月13日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Female
入选标准
- •Stage 1 or 2 operable invasive breast cancer. Estrogen receptor positive (>10% cells)
- •Post-menopausal female
- •Histologically proven invasive adenocarcinoma of the breast through either a core needle biopsy or incisional biopsy Excisional biopsy will not be allowed.Tumour must be confined to either the breast or to the breast and ipsilateral axilla. A complete metastatic staging work-up will be performed prior to definitive surgery, as clinically indicated.
- •Age > =18 years.
- •Karnofsky Performance status index > =80%.
- •Laboratory requirements: (within 28 days prior to registration)
- •Haematology:
- •Neutrophils > =1.5 x 109/L
- •Platelets >=100 x 109/L
- •Haemoglobin > =10 g/dL
- •Hepatic function:
- •Total bilirubin < =1 UNL (patients with a well documented history of Gilbert’s Syndrome are eligible)
- •ASAT (SGOT) and ALAT (SGPT) < =2.5 UNL
- •Alkaline phosphatase < =5 UNL
- •Renal function:
- •Creatinine <= 175 micromol/L (2 mg/dL)
- •Negative pregnancy test (urine or serum) within 7 days prior to registration for all women of childbearing potential.
- •Patients must be postmenopausal defined as:
- •Age >50 y and amenorrheic for 6 months or more
- •Age <50 y and amenorrheic for 12 months or more
- •Prior bilateral oophorectomy
- •Prior hysterectomy and has post menopausal levels of FSH and LH per local institutional standards
- •Age >55 y and prior hysterectomy
排除标准
- •Prior or concurrent systemic anticancer therapy for breast cancer (immunotherapy, hormone therapy, biological, or chemotherapy).
- •Prior or concurrent radiation therapy for breast cancer.
- •Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment.
- •M1 breast cancer.
- •Diabetic patients currenly treated with metformin. Diet controlled diabetic patients are eligible.
- •Other serious illness or medical condition:
- •Congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias,history of significant neurological or psychiatric disorders including psychotic disorders,
- •dementia or seizures that would prohibit the understanding and giving of informed consent,
- •active uncontrolled infection,
- •active peptic ulcer
- •Current history of any neoplasm other than breast carcinoma.
- •Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment should be stopped at least 4 weeks prior to registration.
- •Concurrent treatment with other experimental drugs.
- •Current therapy with any hormonal agent such as raloxifene, tamoxifen or other selective oestrogen receptor modulators (SERMs), either for osteoporosis or prevention. Patients must have discontinued these agents at least four weeks prior to registration.
- •Known allergy reactions or excipients used in the study.
研究者
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