Biomarker Testing and Treatment Patterns Among Patients With PIK3CA Mutation in Advanced Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,093
- 试验地点
- 1
- 主要终点
- Analytical method used for PIK3CA evaluation
研究概览
简要总结
This was a retrospective observational study of patients with advanced breast cancer (BC). This non-interventional study was conducted using discrete structured data and medical record abstraction, if needed, from patients treated at Texas Oncology, the designated research organization and a community oncology practice. The first date of a new diagnosis of advanced BC (de novo or progressed to advanced BC) defined the study index date. To allow for an adequate potential duration of follow-up (retrospectively observed) after the index date over which PIK3CA testing and treatment patterns was observed, a minimum follow-up opportunity of 6 months after the diagnosis of advanced BC at the time of data pull and/or abstraction was required.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who met the following criteria were eligible for abstraction:
- •Newly diagnosed advanced BC between 01 January 2015, and 30 June 2020
- •Evaluated for a PIK3CA mutation and identified PIK3CA gene status
- •No evidence of active other malignant neoplasms within 3 years (except nonmelanoma skin cancer or carcinoma in situ) prior to diagnosis of advanced BC
- •At least 18 years of age at the time of first diagnosis of BC
- •Patients may be alive or deceased at the time of abstraction
- •Not ever enrolled in the following interventional clinical trials evaluating PI3K inhibitors:
- •SOLAR-1 trial (NCT0243731) evaluating alpelisib (BYL719)
- •BELLE-2 or BELLE-3 trial (NCT01610284, NCT01633060) evaluating buparlisib (BKM120)
- •SANDPIPER trial (NCT02340221) evaluating taselisib (GDC-0032)
排除标准
- 未提供
结局指标
主要结局
Analytical method used for PIK3CA evaluation
时间窗: Up to approximately 6 years
Number of patients with PIK3CA mutations
时间窗: Up to approximately 6 years
Time from advanced BC diagnosis to first PIK3CA evaluation
时间窗: Up to approximately 6 years
Number of tests for patients with CDK4/6 inhibitor treatment
时间窗: Up to approximately 6 years
Type of biopsy
时间窗: Up to approximately 6 years
Time from first BC diagnosis to first PIK3CA evaluation
时间窗: Up to approximately 6 years
Time from progression on CDK4/6 inhibitor to first PIK3CA evaluation
时间窗: Up to approximately 6 years
Time from initiation of first-line treatment for advanced BC diagnosis to first PIK3CA evaluation
时间窗: Up to approximately 6 years
Year of (first, where applicable) PIK3CA evaluation
时间窗: Up to approximately 6 years
Result of PIK3CA evaluation (negative, positive, unknown)
时间窗: Up to approximately 6 years
Type of tissue sample, for patients who had tissue biopsy
时间窗: Up to approximately 6 years
Source of tissue sample, for patients who had tissue biopsy
时间窗: Up to approximately 6 years
次要结局
- Number of patients per systemic therapy(Up to approximately 6 years)
- Age at advanced breast cancer diagnosis(Up to approximately 6 years)
- Stage when patients were diagnosed with BC(Up to approximately 6 years)
- Number of patients with known metastatic sites(Up to approximately 6 years)
- Weight(Up to approximately 6 years)
- Height(Up to approximately 6 years)
- Number of patients per line of treatment(Up to approximately 6 years)
- Time from advanced diagnosis to initiation of lines of treatment(Up to approximately 6 years)
- Performance as assessed by Karnofsky Performace Scale(Up to approximately 6 years)
- Number of patients per stage of cancer(Up to approximately 6 years)
- Number of patients per treatment sequence(Up to approximately 6 years)
- Body mass index (BMI)(Up to approximately 6 years)
- Performance as assessed by the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale(Up to approximately 6 years)
- Number of patients per supportive treatment(Up to approximately 6 years)