NCT00291798已完成2 期
Neoadjuvant Endocrinotherapy of Mamma Carcinoma With Exemestane
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 22
- 主要终点
- rate of remission
研究概览
简要总结
The objective of the present clinical investigation is to determine whether hormonal therapy given preoperatively is able to reduce tumor size to an extent that facilitates breast-conserving procedures.
详细描述
This open, prospective multicenter Phase II pilot trial investigates the efficacy of exemestane, 25 mg once daily over 4 months, in postmenopausal women with primary breast cancer, measured in terms of clinical response
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 59 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically verified breast cancer (punch biopsy), established HER-2/neu status
- •Postmenopausal patients (> 1 year following outset of menopause and/or postmenopausal hormonal profile)
- •Clinical staging: T2 (> 3 cm), T3, T4a-c, N0-1
- •Hormone receptor positivity, i.e. estrogen and/or progesterone receptor > 10 fmol/mg cytosolic protein or ER-ICA-positive and/or PgR-ICA-positive. Positivity of + (low-grade) in one hormone receptor is only eligible in the presence of positivity in the other hormone receptor.
- •no internal contraindication
- •life expectation > 6 month
- •written informed consent
排除标准
- •premenopausal patients and patients with no clearly indicated menopausal status
- •manifest second malignant tumor (except basalioma or in situ carcinoma of cervix uteri)
- •uncontrolled internal disease i.e. diabetes mellitus, cardiac disease (NYHA III/IV)
- •thromboembolic disease
- •inflammatory mamma carcinoma
- •existence of distant metastases
- •former or simultaneously therapy with antioestrogens, aromatase inhibitors, cytostatics or radiotherapy
- •corticosteroids before and during the study (except inhalant application)
- •lack of compliance
结局指标
主要结局
rate of remission
次要结局
- collection of disease free survival and overall survival
- Toxicity (WHO-grading)
- rate of mastectomy
- response of tumor subject to HER2-status
研究者
研究点 (22)
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