NCT00237133已完成4 期
PREDICT TRIAL- Neoadjuvant Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women Expressing Hormonal Receptors ( ER and PR)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Safety and tolerability of Letrozole
研究概览
简要总结
Open-label Phase IV trial of Letrozole 2,5mg po/day for 120 days prior to surgery for patients with locally advanced breast in postmenopausal women expressing hormonal receptors ( ER and PR)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women
- •Primary locally invasive breast cancer
- •Histological confirmed by core needle biopsy, whose tumors are estrogen (ER) and / or progesterone (PgR) positive, defined by core biopsy immunohistochemistry with > 10% positive malignant epithelial cells.
- •Post menopausal status
- •Tumor measurable by clinical examination, mammography and ultrasound
排除标准
- •Prior treatment with letrozole or tamoxifen.
- •Patients with bilateral breast tumors
- •Patients who are eligible for breast conserving surgery
- •Evidence of inflammatory breast cancer or distant metastasis.
- •Other concurrent malignant disease
- •Concomitant anti-cancer treatments such as chemotherapy
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Letrozole
Experimental
干预措施: Letrozole (Drug)
结局指标
主要结局
Safety and tolerability of Letrozole
时间窗: frequency and severity of the clinical adverse events
次要结局
未报告次要终点
研究者
研究点 (1)
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Unknown
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