TREATMENT AND MONITORING PATTERNS AND CLINICAL OUTCOMES IN PATIENTS RECEIVING PALBOCICLIB PLUS AROMATASE INHIBITOR OR PALBOCICLIB PLUS FULVESTRANT AS TREATMENT OF HORMONE RECEPTOR POSITIVE (HR+)/HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE (HER2-) ADVANCED OR METASTATIC BREAST CANCER IN A REAL WORLD COMMUNITY ONCOLOGY SETTING
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This is a retrospective, observational study that will document the treatment and monitoring patterns and clinical outcomes of patients diagnosed with HR+/HER2- a/mBC who received Palbociclib combination therapy with aromatase inhibitors or fulvestrant in the a/mBC community oncology setting.
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
- •Patients who are represented in the Vector Oncology Data Warehouse who meet all of the following criteria will be eligible for inclusion in the study.
- •Diagnosis of female breast cancer with evidence of metastatic disease or advanced disease.
- •Diagnosis (confirmed by clinical review) of advanced or metastatic breast cancer at any time, defined as breast cancer at stage IIIb, stage IIIc, or stage IV or identified as having distant metastasis.
- •Indication in the record of ER or PR positive disease, or absence of any indication of ER and PR negative disease (ie, patients are eligible without affirmative indication of ER/PR+ status as long as ER/PR- indication is not present).
- •Receipt of a palbociclib plus aromatase inhibitor (AI) or palbociclib plus fulvestrant regimen on 2/3/2015 or later in the advanced and metastatic setting. Data collection will prioritize accrual of patients with 1L use of palbociclib plus AI and with 2L use of palbociclib plus fulvestrant before collecting other use of palbociclib users.
- •Age greater than or equal to 18 years at A/MBC diagnosis.
排除标准
- •There are no exclusion criteria for this study.
结局指标
主要结局
Overall Survival (OS)
时间窗: A/MBC diagnosis through end of study (assessed up to 24 months)
Proportion of patients receiving various cancer treatment regimens
时间窗: A/MBC diagnosis through end of study (assessed up to 24 months)
Proportion of patients receiving each therapy sequence across lines
时间窗: A/MBC diagnosis through end of study (assessed up to 24 months)
Treatment persistence
时间窗: A/MBC diagnosis through end of study (assessed up to 24 months)
Progression Free Survival (PFS)
时间窗: A/MBC diagnosis through end of study (assessed up to 24 months)
Proportion of patients who discontinue therapy
时间窗: A/MBC diagnosis through end of study (assessed up to 24 months)
Tumor response rate
时间窗: A/MBC diagnosis through end of study (assessed up to 24 months)
Proportion of patients that experience dose adjustment
时间窗: A/MBC diagnosis through end of study (assessed up to 24 months)
次要结局
未报告次要终点