Predicting Recurrence in HR+/HER2- Early Breast Cancer

NCT07484763 | Not Yet Recruiting

• 1 other identifier: LNSZL-LJY01
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Breast Cancer, HR+/HER2- Early-Stage

Keywords

Breast Cancer; HR+/HER2-; Nomogram; Recurrence

Outcome Measures

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.

  5 years

Secondary Outcomes (1)

• Overall survival

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We retrospectively collected data from patients with primary breast cancer who underwent surgical treatment at our center between July 2014 and June 2024.

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

Sponsors & Collaborators

• Shengjing Hospital: lead

MeSH Terms

Conditions

Breast Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03