Additional Prognostic Value of Tumor Grade Beyond the 21-gene Recurrence Score

Not yet recruiting

• Conditions: Breast Cancer; Tumor Grade

• Registration Number: NCT07093775
• Lead Sponsor: Gangnam Severance Hospital

Brief Summary

To evaluated the prognostic significance of tumor grade in patients with node-negative, hormone receptor-positive, and human epidermal growth factor receptor 2-negative breast cancers treated according to RS-guided strategies.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-07-01
• Study First Submitted: 2025-07-15
• Study First Submitted QC: 2025-07-22
• Last Update Submitted: 2025-07-22
• Study First Posted: 2025-07-30
• Last Update Posted: 2025-07-30
• Primary Completion: 2025-12
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

• Patients with hormone receptor-positive, HER2-negative early-stage breast cancer
• Patients treated between January 2011 and December 2023
• Patients with available clinicopathologic data and 21-gene Oncotype DX assay results confirmed through electronic medical records

Exclusion Criteria

• Patients with breast cancer under the age of 20
• Patients diagnosed with stage IV breast cancer
• Patients for whom clinicopathologic data cannot be retrieved from electronic medical records

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence-free interval	through study completion, an average of 5 year