A Single-Center Retrospective Study to Develop a Nomogram for Predicting Recurrence in HR+/HER2- Early Breast Cancer Using Real-World Data
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 主要终点
- Disease-free survival
研究概览
简要总结
Hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer constitutes approximately 70% of all breast cancer cases. Although early-stage patients generally have favorable outcomes following standard surgery and adjuvant endocrine therapy, long-term follow-up data reveal a distinct "bimodal" or "long-tail" recurrence pattern, with risks persisting for decades. Recent landmark trials (e.g., NATALEE, MonarchE) have established that combining CDK4/6 inhibitors with endocrine therapy significantly improves invasive disease-free survival (iDFS) in high-risk populations. However, the stringent enrollment criteria of these randomized controlled trials may not fully capture the heterogeneity of real-world patients. Reliance on binary cut-off values (e.g., nodal status alone) risks misclassifying biologically high-risk individuals with low anatomical burden, leading to either undertreatment or overtreatment. There is an urgent clinical need for a multidimensional, individualized risk assessment tool to guide escalated therapy decisions.
详细描述
Detailed Description Background and Rationale
Hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer constitutes approximately 70% of all breast cancer cases. Although early-stage patients generally have favorable outcomes following standard surgery and adjuvant endocrine therapy, long-term follow-up data reveal a distinct "bimodal" or "long-tail" recurrence pattern, with risks persisting for decades. Recent landmark trials (e.g., NATALEE, MonarchE) have established that combining CDK4/6 inhibitors with endocrine therapy significantly improves invasive disease-free survival (iDFS) in high-risk populations. However, the stringent enrollment criteria of these randomized controlled trials may not fully capture the heterogeneity of real-world patients. Reliance on binary cut-off values (e.g., nodal status alone) risks misclassifying biologically high-risk individuals with low anatomical burden, leading to either undertreatment or overtreatment. There is an urgent clinical need for a multidimensional, individualized risk assessment tool to guide escalated therapy decisions.
Objective
To develop and internally validate a nomogram integrating clinicopathological and lifestyle factors for predicting disease-free survival (DFS) in patients with HR+/HER2- early breast cancer, and to evaluate its clinical utility using decision curve analysis (DCA).
Study Design
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Histopathologically confirmed invasive breast ductal carcinoma or lobular carcinoma;
- •Molecular subtype of HR+/HER2- (ER ≥ 10%, and HER2 immunohistochemistry 0/1+ or 2+ without amplification confirmed by FISH);
- •Received standardized surgical treatment and postoperative adjuvant (or preoperative neoadjuvant) endocrine therapy;
- •Complete follow-up data available.
排除标准
- •Presence of distant metastasis (Stage IV) at diagnosis
- •Male breast cancer
- •Missing key clinicopathological data or loss to follow-up
- •HER2 immunohistochemistry 3+ or 2+ with amplification confirmed by FISH
- •Triple-negative breast cancer
结局指标
主要结局
Disease-free survival
时间窗: 5 years
Disease-free survival refers to the period from breast cancer excision to local recurrence, distant metastasis confirmed by clinical evidence, diagnosis of the second primary tumor or death of the patient.
次要结局
- Overall survival(5 years)
研究者
Jianyi Li
Principal Investigator
Liaoning Cancer Hospital & Institute