FLAME - First Line olAparib Maintenance bEyond BRCA An Observational Cohort Study to Characterize the Outcomes of Olaparib Maintenance Monotherapy Beyond BRCA Mutant Status in Newly Diagnosed Advanced Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Clinical and Demographics characteristics
研究概览
简要总结
This study will collect the data from existing patient medical records at US cancer centers. The study will include patients with BRCAwt ovarian cancer who have been prescribed first line (1L) olaparib maintenance treatment.
详细描述
This is a United States (US) based multicenter, retrospective, observational cohort study with data abstracted from patient medical records.
In this observational study, it is planned to include approximately 150 US female patients with newly diagnosed advanced ovarian cancer (AOC) who were tumor biomarker tested between first diagnosis with AOC and first prescription of 1L olaparib maintenance monotherapy as tumor breast cancer gene wild type (BRCAwt) with a known homologous recombination deficiency (HRD) status.
This retrospective cohort study will include patients with first olaparib prescription between Jan 2017 and Dec 2021. All data collection will be retrospective. Data will be collected from the date of first olaparib prescription (index date) with a follow-up period of at least 18 months post index date.
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 130 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female adult, age ≥ 18 years
- •BRCAwt AOC diagnosed with any approved BRCA test
- •Has documented HRD status based on available test results
- •Received 1L olaparib maintenance monotherapy following platinum chemotherapy
- •Patients must have been treated with platinum-based chemotherapy at first-line
排除标准
- •Received another poly adenosine diphosphate ribose polymerase (PARP) inhibitor or bevacizumab before or while prescribed olaparib
- •Participation in an interventional clinical study
结局指标
主要结局
Clinical and Demographics characteristics
时间窗: At Index date - first olaparib prescription (Jan 2017 to Dec 2021)
Clinical and Demographic characteristics including disease/FIGO stage, histology and tumor grade at initial Ovarian Cancer diagnosis, cancer antigen 125 (CA-125) level, Eastern Cooperative Oncology Group (ECOG) or other performance status, number and type of chemotherapy cycles, cytoreductive/debulking surgery type and outcomes, and selected comorbidities at index date will be described. Summary statistics will be used to describe the Demographics and clinical characteristics. The outcome will be measured for HRD+ patients.
次要结局
- Real-world time to first subsequent treatment or death (rwTFST)(Jan 2017 to Jun 2023)
- Real-world time to treatment discontinuation or death (rwTTD)(Jan 2017 to Jun 2023)
- Number of patients with clinical event of interest (CEI)(Jan 2017 to Jun 2023)