NCT01155063终止不适用
A Non-Interventional Observational Study Evaluating The Effects Of Exemestane Following 2-3 Years Of Adjuvant Tamoxifen Therapy On Safety In Postmenopausal And Hormone Receptors Positive Early Breast Cancer Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 89
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
Evaluating the safety, tolerability and efficacy of Aromasin® when used in routine clinical practice, evaluating adherence to prescribed Aromasin® treatment and to understand reasons for early discontinuation.
详细描述
This study was terminated on 01-Aug-2011 due to very low potential to enroll planned number of patients or any sufficient number of patients for complete statistical analyses. This study is not being terminated because of safety or efficacy concerns.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal females.
- •Patients who have had surgical treatment for histological confirmed breast cancer that was non-metastatic at the time of the initial diagnosis.
- •Patients who are disease-free after 2 or 3 years of adjuvant tamoxifen treatment.
- •Patients whose tumour was estrogen receptor positive (ER+).
- •Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
排除标准
- •Patients for whom Aromasin® treatment is contraindicated (see SPC).
- •Presence of metastasis or a contra lateral tumour.
- •Other adjuvant endocrine therapy.
- •Another concomitant antineoplastic treatment.
- •Participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study.
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: Month 0 up to Month 36 or early withdrawal
An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication.
次要结局
- Number of Participants With Reasons for Discontinuation From Study Treatment(Month 0 up to Month 36 or early withdrawal)
- Time to Discontinuation of Study Medication(Month 0 up to Month 36 or early withdrawal)
- Number of Participants With Concomitant Medications(Month 0 up to Month 36 or early withdrawal)
- Percentage of Participants Who Discontinued the Study Medication(Month 0 up to Month 36 or early withdrawal)
- Number of Participants With Concomitant Morbidities(Month 0 up to Month 36 or early withdrawal)
- Percentage of Participants With Recurrent Disease(Month 36 or early withdrawal)
研究者
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