Last reviewed · How we verify

NCT07484763

Predicting Recurrence in HR+/HER2- Early Breast Cancer

Not yet recruiting Last updated 20 March 2026
What this trial tests

trial in Breast Cancer, HR+/HER2- Early-Stage in 500 participants. Not yet recruiting.

Timeline
1 April 2026
Primary endpoint
1 July 2026
1 April 2027

Quick facts

Lead sponsorShengjing Hospital
StatusNot yet recruiting
Study typeOBSERVATIONAL
Enrollment500
Start date1 April 2026
Primary completion1 July 2026
Estimated completion1 April 2027

Conditions studied

Sponsor

Shengjing Hospital

Who can join

18 and older, female only, with Breast Cancer, HR+/HER2- Early-Stage. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other Shengjing Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07484763.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing