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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Tumor Grade

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tumor grade (I or II vs. III)

Other

We compared the prognosis according to the tumor grade stratified by 21-gene recurrence score

Primary outcomes

Recurrence-free interval

Time frame: through study completion, an average of 5 year

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study title

Prognostic Implication of Tumor Grade in Patients With Node-negative Breast Cancer Aged ≤ 50 Years With 21-gene Recurrence Scores of 11-25

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Jul 30, 2025
Registry last updated: Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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