Predicting Recurrence in HR+/HER2- Early Breast Cancer
Starting soon
Conditions studied: Breast Cancer, HR+/HER2- Early-Stage
In brief
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.
Key facts
- Study ID
- NCT07484763
- Run by
- Shengjing Hospital
- People needed
- 500
- Starts
- 2026-04-01
- Expected to finish
- 2027-04-01
- Last updated by the study team
- 2026-03-20
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Full record on ClinicalTrials.gov
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