A Non-Interventional Study With Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer Who Are Disease-Free After 2-3 Years Of Initial Adjuvant Tamoxifen Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 46
- 试验地点
- 11
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
This non-interventional study will be conducted in several Eastern European countries to assess the safety, tolerability and efficacy of Aromasin® when it is administered in real-word setting in postmenopausal women with invasive estrogen receptor positive early breast cancer , who are disease-free after completion of 2 to 3 years of tamoxifen and continue the treatment with Aromasin® until completion of 5 years of adjuvant hormonal therapy, to understand how Aromasin® is used in routine clinical practice, to assess adherence to prescribed Aromasin® treatment and to understand reasons for its early discontinuation.
详细描述
The study prematurely discontinued on October 11, 2011 due to slow enrollment. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal females, defined as one from the next :
- •Natural menopause ≥1 year,
- •Surgical ovariectomy,
- •Chemotherapy-induced amenorrhoea ≥ 2 years.
- •Patients who have had surgical treatment for histologically confirmed breast cancer that was non-metastatic at the time of the initial diagnosis.
- •Patients who are disease-free after 2 to 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 SmPC).
- •Metastatic breast cancer or a contra lateral tumour.
- •Other concomitant adjuvant endocrine therapy.
- •Other concomitant antineoplastic treatment.
- •Participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study.
研究组 & 干预措施
1
干预措施: Aromasin (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: Baseline up to Month 36
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness (to study drug) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
次要结局
- Number of Participants With Concomitant Morbidities(Baseline up to Month 36)
- Number of Participants With Concomitant Medications(Baseline up to Month 36)
- Percentage of Participants Who Discontinued the Study Medication(Baseline up to Month 36)
- Number of Participants With Reasons for Discontinuation From Study Medication(Baseline up to Month 36)
- Time to Discontinuation(Baseline up to Month 36)
- Recurrence-free Survival(Baseline up to Month 36)
- Overall Survival(Baseline until death (up to Month 36))