Clinical trial · Observational
Predicting Recurrence in HR+/HER2- Early Breast Cancer
A Single-Center Retrospective Study to Develop a Nomogram for Predicting Recurrence in HR+/HER2- Early Breast Cancer Using Real-World Data
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer, HR+/HER2- Early-Stage | Malignant Breast Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Disease-free survival
- timeFrame
- 5 years
- description
- 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.
Secondary outcomes (1)
- measure
- Overall survival
- timeFrame
- 5 years
- description
- Overall survival refers to the time from breast cancer excision to death due to any cause
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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
References
Publications (0)
Data not yet available