Real-World Patient Characteristics, Treatment Patterns, and Clinical Outcomes Among Talazoparib-Treated Patients With HER2-Negative, Locally Advanced or Metastatic Breast Cancer and Germline BRCA1/2 Mutations: US Chart Review
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Time to Treatment Failure (TTF) for Talazoparib
研究概览
简要总结
This study is a retrospective, multi-site, patient-level medical chart review of US adult patients with locally advanced or metastatic breast cancer (ABC) who initiated talazoparib on or after October 16, 2018 and were managed by participating providers from Cardinal Health's Oncology Provider Extended Network (OPEN).
This study will describe patient characteristics, treatment patterns, and clinical outcomes of talazoparib-treated patients in real-world practice setting in US.
The primary population for this study includes:
-HER2-negative ABC patients with germline BRCA1/2 (gBRCA1/2) mutations treated with talazoparib monotherapy initiated on or after October 16, 2018 and ≥18 years of age at initiation of talazoparib.
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
- •Diagnosed with HER2-negative ABC
- •gBRCA1/2 mutation(s)
- •Treatment with talazoparib monotherapy initiated on or after October 16, 2018
- •≥18 years of age at initiation of talazoparib
- •A minimum of 6 months follow-up time after initiation of talazoparib unless the patient died within this follow-up period
排除标准
- •Participation in any BC clinical trial after initiation of talazoparib
- •Treatment with a PARP inhibitor as neoadjuvant/adjuvant therapy
- •gBRCA1/2 or HER2 status unknown
- •Diagnosis of any other malignancy, except carcinoma in situ or nonmelanoma skin cancer, within the 5 years prior to data collection
研究组 & 干预措施
Primary population: Talazoparib-treated patients with HER2- ABC with gBRCA1/2m
HER2-negative ABC patients with gBRCA1/2 mutations treated with talazoparib monotherapy initiated on or after October 16, 2018 and ≥18 years of age at initiation of talazoparib.
干预措施: Talazoparib (Drug)
结局指标
主要结局
Time to Treatment Failure (TTF) for Talazoparib
时间窗: Index date up to talazoparib discontinuation, from 16-October-2018 maximum up to 11-October-2021 (approximately 36 months); data retrieved and studied from 20-August-2021 to 11-October-2021 (approximately 1.7 months of this study)
TTF was defined as the time from initiation of talazoparib to discontinuation for any reason, which included disease progression, treatment toxicity, and death. Index date was defined as the date of initiation of talazoparib on or after 16-October-2018. Median was analyzed using the Kaplan-Meier method.
次要结局
- Real-World Progression Free Survival (rwPFS) From Initiation of Talazoparib(Index date up to charted disease progression, from 16-October-2018 maximum up to 11-October-2021 (approximately 36 months); data retrieved and studied from 20-August-2021 to 11-October-2021 (approximately 1.7 months of this study))
- Time From Initiation of Talazoparib to Initiation of Subsequent Chemotherapy(Index date up to initiation of subsequent chemotherapy, from 16-October-2018 maximum up to 11-October-2021 (approximately 36 months); data retrieved and studied from 20-August-2021 to 11-October-2021 (approximately 1.7 months of this study))