NCT00309491已完成3 期
A Randomized Phase III Study Comparing Tamoxifen vs. Tamoxifen + Aminoglutethimide in Postmenopausal, Hormone Receptor-positive Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,021
- 主要终点
- Overall survival
研究概览
简要总结
Primarily, this clinical investigation compared the efficacy of tamoxifen + aminoglutethimide vs. tamoxifen alone in terms of prognosis (overall survival) in postmenopausal patients with potentially curative, operated hormone receptor-positive breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal patients with histologically verified, locoradically treated, invasive or minimally invasive breast cancer
- •Hormone receptor-positive status
- •More than 6 histologically examined lymph nodes
- •Laboratory parameters
- •hematopoiesis: > 3500/µl leucocytes, > 100,000/µl thrombocytes
- •renal function: creatinin < 1.5mg%
- •hepatic function: GOT < 2.5 x UNL
- •bilirubin: < 1.5mg %
- •metabolic parameters: Na, Ca, K in normal range, normal level of blood sugar
- •Concluded healing process following surgery
- •Less than 4 weeks interval since surgery
- •Informed consent
排除标准
- •Premenopausal patients, non-determinable menopausal status
- •Previous radiotherapy, chemotherapy or endocrine treatment
- •Generalized disease (as verified by lung X-ray, skeletal X-ray, liver ultrasound)
- •Contraindications against tamoxifen or anastrozole
- •T4 tumors; carcinoma in situ
- •Lacking compliance or understanding of disease
- •Karnofsky Index < 3
- •Serious concomitant disease
- •Septic complications, systemic infections or infectious local processes
- •Bilateral ovariectomy or ovarian irradiation
- •Second carcinoma or status post second carcinoma (except for treated squamous cell carcinoma of the skin or cervical carcinoma in situ)
研究组 & 干预措施
Group I
Experimental
Tamoxifen alone
干预措施: Tamoxifen alone (Drug)
Group II
Experimental
Tamoxifen + Aminoglutethimide
干预措施: Tamoxifen alone (Drug)
Group II
Experimental
Tamoxifen + Aminoglutethimide
干预措施: Tamoxifen + Aminoglutethimide (Drug)
结局指标
主要结局
Overall survival
次要结局
- Recurrence-free survival
- Side-effect profiles
研究者
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