ACTRN12606000499583已完成3 期
ANZ 8811: A Phase III study to compare the effect of Zoladex depot (ICI 118, 630) with Nolvadex plus Zoladex depot in pre- and peri-menopausal patients with advanced breast cancer.
Australian New Zealand Breast Cancer Trials Group (ANZ BCTG)0 个研究点目标入组 180 人开始时间: 1994年11月3日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 ot stated（—）
- 性别
- Female
入选标准
- •a) Histologically or cytologically proven diagnosis of invasive primary breast cancer.b) Locally recurrent or locally advanced breast cancer (a locally advanced breast cancer which is 5cm diameter or greater on clinical measurement or fixed to the chest wall - T1b, T2b, T3b or T4) or distant metastases in bone, lung or soft tissue.c) One measurable or evaluable lesion.d) Pre or peri-menopausal women e) Informed consent to participate in the trial.
排除标准
- •a) Adjuvant hormone or adjuvant anti-hormone therapy within the last 6 months.b) Adjuvant cytotoxic therapy within the last six months. Patients who are amenorrhoeic more than six months after adjuvant cytotoxic therapy should have menopausal status confirmed by serum levels of FSH.c) Prior therapy for advanced disease at any time.d) Concurrent invasive malignancy within the last five years.e) Pregnancyf) Pre-existing sex endocrine disorders.
研究者
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