An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Number of Participants With Appearance of Second Primary or Contralateral Breast Cancer
研究概览
简要总结
To generate the following data from patients with early breast cancer treated with Aromasin® in the adjuvant setting in India.
- Efficacy of the treatment with Aromasin®
- Safety of the treatment with Aromasin®
详细描述
NA The study was prematurely discontinued due to slow enrollment and keeping in mind the observational nature of the study. The decision to terminate had been taken on 16th June 2012 and the LSLV occured on 14th September, 2012. 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 Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with early breast cancer receiving adjuvant therapy with Aromasin® will be eligible.
排除标准
- •Patients presenting with in situ cancers, recurrent or metastatic breast cancer, or a 2nd primary will not be included.
- •Patients with a known hypersensitivity to Exemestane or its metabolites will also not be included.
结局指标
主要结局
Number of Participants With Appearance of Second Primary or Contralateral Breast Cancer
时间窗: Baseline until appearance of second primary or contralateral breast cancer (up to Year 3.5)
Number of Participants Who Died
时间窗: Baseline until death (up to Year 3.5)
Number of Participants With Locoregional/Distant Recurrence of Primary Breast Cancer
时间窗: Baseline until locoregional/distant recurrence of primary breast cancer (up to Year 3.5)
Locoregional recurrence was defined as any recurrence of the breast cancer in the ipsilateral breast, chest wall or axillary lymph nodes.
Number of Participants Who Discontinued Aromasin Therapy
时间窗: Baseline until discontinuation (up to Year 3.5)
Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs)
时间窗: Baseline up to 28 days after last dose of study treatment
An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Number of participants with AEs related to gynecological, cardiac, venous thromboembolic, musculoskeletal and menopausal symptoms were reported. Gynecological AEs: bleeding, discharge, uterine dilatation and curettage; cardiac AEs: myocardial infarction, hypertension; musculoskeletal: joint stiffness, arthralgia, muscle cramps, fractures; menopausal symptoms: hot flushes, anxiety, depression, headache.
Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C), Total Cholesterol and Triglycerides at Month 6, 12, 18, 24, 30, 36 and 42
时间窗: Baseline, Month 6, 12, 18, 24, 30, 36, 42
Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24, 30, 36 and 42
时间窗: Baseline, Month 6, 12, 18, 24, 30, 36, 42
次要结局
未报告次要终点