About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
We retrospectively collected data from patients with primary breast cancer who underwent surgical treatment at our center between July 2014 and June 2024.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Disease-free survival
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
Overall survival
Overall survival refers to the time from breast cancer excision to death due to any cause
Locations
Sponsors and contacts
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Shengjing Hospital
Lead sponsor
Liaoning Cancer Hospital & Institute
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options: