Identify Predictors of Clinical Outcomes in Real-world Patients With HR+ and HER2-low/Negative Breast Cancer Treated With Neoadjuvant Chemotherapy or Endocrine Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 927
- 试验地点
- 1
- 主要终点
- Event-free survival (EFS) in Participants With HR+ and HER2-Low/Negative Breast Cancer
研究概览
简要总结
There is a lack of data on clinical and patient factors that are associated with poor survival in patients with HR+ and HER2-low/negative breast cancer treated with neoadjuvant chemotherapy or endocrine therapy. This retrospective, non-interventional study is designed to assess the predictors of clinical outcomes in this patient population. No study drug will be provided as part of this study protocol.
详细描述
This retrospective, non-interventional study is designed to assess the following primary objectives:
- To identify predictors of event-free survival (EFS) in patients with HR+ and HER2-low/negative breast cancer treated with neoadjuvant chemotherapy or endocrine therapy, and
- To stratify patients according to event-free survival using different combinations of significant predictors and evaluate the patient characteristics and clinical outcomes such as EFS, overall survival and pathological complete response across patient groups of different risk level.
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
- •Newly diagnosed HR+ and HER2-low/negative breast cancer diagnosed between January 1, 2010 and December 31, 2022 (Aged ≥18 years at the time of diagnosis)
- •Stage I-IIIB at the time of diagnosis
- •Received neoadjuvant chemotherapy and/or endocrine therapy and/or IO therapy
- •Received curative intent surgery (mastectomy after neoadjuvant chemotherapy, endocrine, or IO therapy)
排除标准
- •Patients who received HER2-targeted therapies including
- •Trastuzumab
- •Pertuzumab
- •Ado-trastuzumab emtansine
- •Neratinib
- •Tucatinib
- •Lapatinib
- •Fam-trastuzumab deruxtecan-nxki
- •Margetuximab
结局指标
主要结局
Event-free survival (EFS) in Participants With HR+ and HER2-Low/Negative Breast Cancer
时间窗: Index date to the end of the study period (approximately December 31, 2022)
Events of interest include any other primary cancer, metastases, higher stage, tumor progression, and death due to any cause.
Overall Survival of Participants With HR+ and HER2-Low/Negative Breast Cancer
时间窗: Index date to the end of the study period (approximately December 31, 2022)
Pathological Complete Response (pCR) in Participants With HR+ and HER2-Low/Negative Breast Cancer
时间窗: Index date to the end of the study period (approximately December 31, 2022)
Pathological complete response (pCR) was defined as ypT0/Tis ypN0 and is the absence of any invasive component in the resected breast specimen and all resected lymph nodes following completion of neoadjuvant therapy.
次要结局
未报告次要终点