NCT01972984已完成2 期
The NEO (NEOADJUVANT ENDOCRINE OUTCOMES) TRIAL: Neoadjuvant Endocrine Therapy for Primary Breast Cancer: Investigation of Clinical and Translational Outcomes
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percentage of patients who fit the eligibility criteria that consent to the study; withdraw after consent from the study.
研究概览
简要总结
- Women with operable breast cancer with a 2-8 week preoperative waiting period will accept preoperative therapy trials and specifically taking a standard drug for breast cancer such as anastrozole in this study
- Short term anastrozole treatment will induce measurable changes in biomarker levels (ER, PR, Her2, Ki67) within the tumor.
- Degree of response to short term anastrozole varies with a) duration of treatment and b) breast cancer subtype (based on initial pre-treatment biomarker status)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed postmenopausal women (Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL and estradiol < 20 pg/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago.)
- •Confirmation of estrogen receptor positive invasive carcinoma on core biopsy
- •Patients whose cancers are palpable and have been deemed to be "operable" by the surgeon
- •Surgery is planned for the next 2-8 weeks.
排除标准
- •History of hormone replacement therapy in the last 6 months
- •Previous treatment by tamoxifen or aromatase inhibitor treatment in six months
- •Known hypersensitivity or contraindications to aromatase inhibitors
- •Known metastatic disease on presentation
- •Recurrent breast cancer
- •Inability to give informed consent
研究组 & 干预措施
Anastrozole
Experimental
All qualifying women will receive anastrozole at the usual dose of 1mg daily for 2-6 weeks leading up to their surgery
干预措施: Anastrozole (Drug)
结局指标
主要结局
Percentage of patients who fit the eligibility criteria that consent to the study; withdraw after consent from the study.
时间窗: up to 18 months
Participants are on study from the time their eligibility is confirmed until the time of their surgery which could be up to 8 weeks. This is a feasibility study and therefore once the study is closed to accrual the percent of women who signed consent and remained on study until their surgery versus those who withdraw will be determined.
次要结局
- Measure the changes in ER, PR, Her2 and Ki67 labelling index on pre- and post treatment tumor tissue(Up to 18 months)
研究者
研究点 (1)
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