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

Launched by GANGNAM SEVERANCE HOSPITAL · Jul 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether the grade of a breast tumor—how much the cancer cells look like normal cells—can help doctors better predict the outlook for patients with a specific type of early breast cancer. These patients have hormone receptor-positive, HER2-negative breast cancer that hasn’t spread to the lymph nodes. The study looks at this tumor grade alongside results from a test called the 21-gene recurrence score, which helps guide treatment decisions.

People who might be eligible for this study include adults diagnosed with this type of breast cancer between 2011 and 2023 who have complete medical records and results from the 21-gene test. The trial is not yet enrolling patients, and it does not include those under 20 years old or with advanced (stage IV) cancer. Participants won’t have to undergo new treatments for this study—it mainly involves reviewing existing medical information to see how tumor grade adds to current tools doctors use to predict cancer outcomes. This research could help improve how treatment plans are made in the future.

Gender

ALL

Eligibility criteria

• 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