A Retrospective Study to Understand the Clinical Characteristics andthe Treatment Patterns For HR positive, HER2 negative High-Risk Early Breast CancerPatients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 550
- 试验地点
- 5
- 主要终点
- To describe the proportion of patients with a high risk of relapse, as defined by MonarchE
研究概览
简要总结
The current observational study aims to obtain real-world data about the proportion of patients with a high risk of relapse, as defined by MonarchE inclusion criteria (1), out of the total number of HR+/ HER2- early breast cancer cases, in four countries: KSA, UAE, Turkey, and India. The study also aims to obtain real world data about the treatment patterns and clinical characteristics in HR+, HER2- early breast cancer patients.
The primary study objective is to describe the proportion of patients with high risk of relapse, as defined by MonarchE inclusion criteria*, out of the total number of the recruited cases.The study’s secondary objective is to describe the treatment patterns and clinical characteristics in HR+, HER2- early breast cancer patients (EBC)
HR+/ HER2- early breast cancer patients with a high risk of relapse defined as patients with four or more positive pathologic axillary lymph nodes or one to three positive axillary lymph nodes and at least one of the following: tumour size ≥ 5 cm, histologic grade 3, or Ki-67 ≥ 20%.
All study data will be collected retrospectively from the medical records and will cover the period of 2 years before the data collection date, from the date of early breast cancer patients (EBC) patients’ diagnosis until patients’ inclusion dates. Since a predetermined number of cases are sought from each country, then quota sampling will be used. Within each country/site, convenience sampling will be used to collect data from available records.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Adult women ≥18 years of age (or per local regulations).
- •The participant has confirmed HR+, HER2-, early-stage resected invasive breast cancer without evidence of distant metastases.
- •The participant must have undergone definitive surgery of the primary breast tumor.
- •The participant must have tumor tissue from the breast (preferred) or lymph node.
排除标准
- •Distant metastasis.
- •No other explicit exclusion criteria are defined to allow for documentation of routine clinical practice as much as possible.
结局指标
主要结局
To describe the proportion of patients with a high risk of relapse, as defined by MonarchE
时间窗: At Baseline, one-time assessment only.
inclusion criteria, out of the total number of the recruited cases of HR+, HER2- early
时间窗: At Baseline, one-time assessment only.
breast cancer patients (EBC)
时间窗: At Baseline, one-time assessment only.
次要结局
- To describe the treatment patterns & clinical characteristics in HR positive, HER2 negative early breast(cancer patients (EBC).)