NCT00232661已完成3 期
A Randomised, Double-blind, Study Comparing ARIMIDEX™ With NOLVADEX™ as Neo-adjuvant and Adjuvant Treatment in Post-menopausal Women With Large Operable (T2 (≥3cm), T3, N0-2, M0) or Potentially-operable, Locally Advanced (T4b, N0-2, M0), ER+ and/or PR+ Breast Cancer.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 452
- 试验地点
- 77
- 主要终点
- Objective tumour response
研究概览
简要总结
The purpose of this study is to compare tamoxifen, versus a newer treatment, ARIMIDEX, which we already know to be well tolerated. The main objectives of this research study are to see whether using these drugs will shrink down tumours before surgery and to see if any shrinkage in the tumour affects the extent of surgery that is required.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Operable or potentially operable breast cancer
- •Invasive breast cancer proven to be hormone-sensitive (ER+/PR+)
- •Patients who might benefit from endocrine treatment prior to surgery
- •Postmenopausal
- •Signed written informed consent
排除标准
- •Inoperable breast cancer
- •Patient unwilling to undergo surgery
- •Any reason why the patient may not be able to conform to study requirements
- •Any previous treatment for breast cancer
- •Previous Tamoxifen use as a part of breast cancer prevention trials
- •Not willing to stop taking drugs that affect sex-hormones such as HRT
- •Previous history of breast cancer
- •Previous history of invasive malignancy within the last 10 years
- •Any other severe disease that may prevent surgery, place the patient at risk, or influence the study results
- •Treatment with an experimental drug within the last 3 months
- •Risk of transmitting HIV, Hepatitis B or C
结局指标
主要结局
Objective tumour response
时间窗: Assessed at 3 months
次要结局
- Pathological response(Assessed at 3 months)
- Extent of breast surgery(Assessed at 3 months)
- Extent of axillary down-staging(Assessed at 3 months)
- Clinical ultrasound response versus clinical caliper response(Assessed at 3 months)
- Safety(Assessed up to 5 years + 30 days)
- Complications due to surgery(Assessed up to 30 days post-surgery)
- Health economics outcomes(Assessed up to 30 days post-surgery)
- Quality of Life assessments(Assessed at 3 months)
- Effect of ethnicity with respect to baseline patient and tumour characteristics, safety and objective tumour response rate(Assessed up to 5 years + 30 days)
- Recurrence-free survival and survival(Assessed up to 5 years)
研究者
研究点 (77)
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