NCT00237224已完成4 期
Open Label Study of Postmenopausal Women With ER and /or PgR Positive Breast Cancer Treated With Letrozole
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
- 40
- 试验地点
- 1
- 主要终点
- Identify Eg and/or Pg receptors in breast cancer patients in adjuvant treatment with tamoxifen for 4-5 years
研究概览
简要总结
To evaluate safety and efficacy (measured by clinical tumor response) of letrozole daily dose, 2.5 mg in postmenopausal patients with primary (untreated) breast cancer.
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
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal woman able to comply with the protocol requirements with primary invasive breast cancer, histologically 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.
- •Clinical stage *T2, T3, T4a,b,c, N0, 1 or 2, M0
- •Clinical stage T2 tumors which in the Investigators opinion would not be eligible for breast-conserving surgery.
- •Post menopausal status defined by one of the following:
- •No spontaneous menses for at least 1 year, in women > 55 years.
- •Spontaneous menses within the past 1 year but amenorrhoeic in women ≤ 55 years (e.g. spontaneous or secondary to hysterectomy), and with postmenopausal gonadotrophin levels (LH y FSH levels > 40 IU/L) or postmenopausal estradiol levels (< 5 ng/dl) or according to the definition of "postmenopausal range" for the laboratory involved.
- •Bilateral oophorectomy. (Prior to the diagnosis of breast cancer).
- •Tumor measurable by clinical examination, mammography and ultrasound.
排除标准
- •Prior treatment with letrozole or tamoxifen.
- •Uncontrolled endocrine disorders such as diabetes mellitus, confirmed hypo- or hyperthyroidism, Cushing's Syndrome, Addison's disease (treated or untreated).
- •Patients with unstable, angina, or uncontrolled cardiac disease (e.g. Class III or IV New York Heart association's Functional Classification).
- •Patients with bilateral breast tumors
- •Patients who are eligible for breast conserving surgery
- •Evidence of inflammatory breast cancer or distant metastasis.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
FEM345
Experimental
干预措施: Letrozole (Drug)
结局指标
主要结局
Identify Eg and/or Pg receptors in breast cancer patients in adjuvant treatment with tamoxifen for 4-5 years
时间窗: 4 months
次要结局
- Identify the number of patients in adjuvant treatment with tamoxifen within 4-5 years or close to end this treatment time(4 months)
- Determine the relation of positive Eg / Pg receptors vs negative (unknown) Eg / Pg receptors and the only selection criteria for the adjuvant treatment with tamoxifen is postmenopause status(4 months)
研究者
研究点 (1)
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