Treatment Patterns And Clinical Outcomes Among Patients Receiving CDK4/6 Inhibitors Combinations For HR+/HER2- Advanced/Metastatic Breast Cancer In A Canadian Real World Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Number of Participants Classified According to Treatment Pattern
研究概览
简要总结
CDK4/6 inhibitors are approved medicines indicated for the treatment of a kind of advanced/metastatic breast cancer, called hormone receptors positive (HR+)/ Human epidermal growth factor receptor 2 negative (HER2-) disease. They are given orally in combination with hormonal therapies.
The purpose of this study is to better understand how the CDK4/6 inhibitors combinations are used in real-life conditions and their clinical impact for the treatment of Canadian patients affected by (HR+)/ (HER2-) advanced breast cancer (ABC) or metastatic breast cancer (MBC).
Female patients aged 18 years old or more presenting the following conditions will be selected for the study:
- HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease
- Diagnosis of ABC/MBC between 01 January 2016 and 01 July 2021
- Treatment with CDK4/6 inhibitor
Information will be collected from one single Canadian institution, on each selected real-life patient treated with CDK4/6 inhibitors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease
- •Diagnosed with ABC/MBC between 01 Jan 2016 and 01 July 2021
- •Treatment with CDK4/6 inhibitor
排除标准
- •Patient does not have ABC/MBC
- •Patient has indicated HR- or HER2+ status
- •Patient received a CDK4/6i as part of a clinical trial
结局指标
主要结局
Number of Participants Classified According to Treatment Pattern
时间窗: From date of ABC/MBC diagnosis until date of death, date of last follow-up or the end of the study period, whichever came first (maximum follow-up of 67.6 months); available data evaluated over approximately 4.5 months of this retrospective study
Number of participants according to the treatment patterns for first line, second line and third line were reported in this outcome measure. CDK4/6i included abemaciclib, palbociclib and ribociclib. Endocrine therapy (ET) included anastrozole, exemestane, fulvestrant, letrozole and tamoxifen. Chemotherapy included capecitabine, cisplatin, cyclophosphamide, docetaxel, doxorubicin, eribulin, gemcitabine and paclitaxel.
次要结局
- Number of Participants Classified According to Type of Treatment Before Introduction of CDK4/6 Inhibitor(From date of ABC/MBC diagnosis until introduction of CDK 4/6 inhibitor(anytime between Jan 2016 to May 2016, approximately 4 months); available data evaluated over approximately 4.5 months of this retrospective study)
- Number of Participants Classified According to Type of Treatment After Introduction of CDK4/6 Inhibitor(From date of introduction of CDK4/6 inhibitor until date of death, date of last follow-up or the end of the study period, whichever came first (approximately 33 months); available data evaluated over approximately 4.5 months of this retrospective study)