Predicting Recurrence in HR+/HER2- Early Breast Cancer

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorShengjing Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
5 years

Secondary outcomes

1

Overall survival

Overall survival refers to the time from breast cancer excision to death due to any cause

Time frame
5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Shengjing Hospital

Lead sponsor

Liaoning Cancer Hospital & Institute

Sponsor institution

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