ISRCTN75225940已完成未知
An open label, randomised multicentre comparative trial of five years adjuvant exemestane treatment versus adjuvant tamoxifen followed by exemestane in postmenopausal women with early breast cancer
The University of Birmingham (UK)0 个研究点目标入组 1,275 人开始时间: 2001年7月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 1,275
研究概览
简要总结
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21247627
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Women with histologically/cytologically confirmed early adenocarcinoma of the breast, completely excised by surgery with curative intent (Ro) including:
- •1.1. Any node-positive cancer
- •1.2. Any cancer greater than or equal to 3 cm
- •1.3. Node negative cancer, grade II or III and 1 cm or greater
- •2. ER and/or PgR status positive
- •3. Postmenopausal
- •4. Patients on Hormone Replacement Therapy (HRT) which was discontinued at least four weeks prior to randomisation
- •5. Adequate haematological, renal and hepatic function
- •6. Accessible for follow-up for the duration of the trial
- •7. Eastern Cooperative Oncology Group (ECOG) performance status zero, one or two
- •8. Written informed consent (according to International Conference on Harmonisation [ICH]/Good Clinical Practice [GCP] and local Institutional Review Board [IRB] guidelines)
- •9. Randomisation within ten weeks of completing surgery +/- adjuvant chemotherapy
排除标准
- •1. Positive supraclavicular nodes
- •2. Evidence of distant metastases (M1)
- •3. Patients whose chemotherapy was started more than ten weeks after completion of primary surgery
- •4. Patients who have received previous hormonal treatment as adjuvant treatment for breast cancer
- •5. Patients who have received neoadjuvant chemotherapy
- •6. Neoadjuvant hormone therapy more than four weeks duration prior to surgery
- •7. Severe osteoporosis (bisphosphonates for therapeutic use is not an exclusion criterion)
- •8. Uncontrolled cardiac disease including unstable angina, Congestive Heart Failure (CHF) or arrhythmia requiring medical therapy or with a history of myocardial infarction within the past 3 months or any other serious concomitant disease
- •9. Psychiatric disorders preventing proper informed consent
- •10. Concomitant malignancies except for adequately treated carcinoma in situ of the uterine cervix or basal cell carcinoma of the skin
- •11. Patients with other malignancies must be disease free for at least five years
- •12. Concurrent participation in another clinical study (with the exception of adjuvant cytotoxic chemotherapy trials) involving investigational agents that may interfere with the results of the trial
- •13. Other serious illnesses that may interfere with subject compliance, adequate informed consent or determination of causality of adverse events
- •14. Patients on HRT, which was not discontinued at least four weeks prior to randomisation
- •15. Node-negative, grade I cancer less than 3 cm
研究者
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