NCT00919399已完成2 期
Phase II Study Evaluating the Effectiveness of the Exemestane (Aromasin) With Tamoxifen on the Rate of Clinical Response Menopausal in Patients With Locally Advanced Breast Tumors
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Evaluate the objective response rate (complete response and partial response)
研究概览
简要总结
This is a Phase II non-randomized, open, uncontrolled and bi-centric study of hormonal induction by exemestane (Aromasin) + tamoxifen to evaluate the effectiveness of exemestane (Aromasin) with tamoxifen on the rate of clinical response menopausal in patients with tumors of locally advanced breast. Hormone therapy will be administered at a dose of 25mg/day for exemestane and 20 mg / day for 4 months for tamoxifen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer histologically proven by a 14 G or 16 G micro-biopsy to have confirmation of the diagnosis, evaluation histology prognosis grade, hormone receptors and to obtain a sample for the study of biological factors.
- •Menopausal patients as defined as follows:
- •Natural menopause >= 1 year, or
- •Surgical ovariectomy.
- •T unilateral tumor> 3 cm, N 1-2, M0 or M +, non-inflammatory.
- •Hormone receptor positive. RE positive or PR positive with histochemical technique (+ 10% of cells express the receptor)
- •No previous treatment of the disease by chemotherapy, hormone therapy, surgery or radiotherapy. Discontinuation of replacement therapy of menopause for at least 1 month
- •Age>= 60 years
- •Evaluable disease
- •Performance Status <= 2
- •Biological function using the following criteria:
- •neutrophils >= 2.10E9 / l,
- •Platelets> = 100.10E9 / l,
- •Hemoglobin> = 10 g / dl,
- •Creatinine <= 1.5 x upper normal,
- •Total bilirubin <= 1.25 x the upper normal
- •Transaminases (AST and ALT) <= 1.5 x upper normal,
- •Alkaline phosphatase <= 2.5 x upper normal.
- •Cardiac Function: electrocardiogram (ECG) normal.
- •Signed written consent before any procedure related to the study.
排除标准
- •Non Menopausal Patients
- •Patients with hormone receptor negative: PR- and RE -
- •Contra-indication to anti-estrogens (risk thrombi arteria)
- •Tumor <3 cm operable
- •Tumor inflammatory T4d (PEV 2 or 3).
- •Extensive hepatic lesions (> 1 / 3 of liver volume)
- •Uncontrolled cardiac disease such as angina, congestive heart failure, or arrhythmia requiring medical treatment or history of myocardial infarction within 3 months before.
- •History of cancer except skin cancer and basal cell cancer in situ of the cervix (a contralateral breast cancer had been no systemic treatment will be admitted).
- •Chronic diseases (somatic or psychiatric) in poor prognosis.
- •Patients who for reasons of family, social, geographical or psychological can not be followed properly.
- •Patients under law protection
结局指标
主要结局
Evaluate the objective response rate (complete response and partial response)
时间窗: June 2006
次要结局
- Pharmacokinetic interaction between Exemestane and Tamoxifen(june 2006)
研究者
研究点 (2)
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