EUCTR2006-003932-32-GB进行中（未招募）1 期
Endocrine +/- Surgical Therapy for Elderly women with Mammary cancer - ESTEeM
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •(1) Female and equal to or over 75 years of age.
- •(2) Primary operable (TNM categories: T1, T2, T3, N0, N1, M0) invasive breast cancer (core biopsy or diagnostic incision biopsy proven).
- •(3) Suitable for surgery. This may include local or general anaesthesia, and must remove all clinically palpable disease with clear pathological margins. Axillary staging for the clinically un-involved axilla will depend on local protocols and patient tolerance.
- •(4) Moderate or strongly ER+ve, i.e. H Score equal to or greater than 100 or Allred Score equal to or greater than 5.
- •(5) Ability to give informed consent.
- •(6) Written informed consent.
- •(7) Willing to complete the questionnaires for the additional trial evaluations.
- •(8) Able to start trial treatment within 4 weeks of randomisation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •(1) Disease unsuitable for surgery, e.g. locally advanced or metastatic disease, extreme physical frailty precluding adequate surgery under either LA or GA.
- •(2) Multifocal or bilateral invasive breast cancer.
- •(3) Previous invasive breast cancer.
- •(4) Previous or concurrent anti-oestrogen therapy for breast cancer.
- •(5) Previous solid cancers other than breast in the last 10 years (except in the case of completely excised basal cell carcinoma/nonmelanomatous skin malignancy).
- •(6) Inability to comply with study procedures.
- •(7) History of severe renal impairment (creatinine clearance less than 20 ml/min).
- •(8) History of moderate or severe hepatic disease (transaminases > 3 x ULN or bilirubin > 1.5 x ULN).
- •(9) Known hypersensitivity to anastrozole or to any of the following excipients: Lactose Monohydrate, Povidone, Sodium Starch Glycollate, Magnesium Stearate, Hypromellose, Macrogol 300, or Titanium Dioxide.
- •(10) Concurrent hormone replacement therapy (HRT) or therapy with any other oestrogen containing preparation.
- •(11) Hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
研究者
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