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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07093775
Enrollment
4000
Registered
2025-07-30
Start date
2025-07-31
Completion date
2026-03-31
Last updated
2025-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Tumor Grade

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.

Interventions

OTHERTumor grade (I or II vs. III)

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

Sponsors

Gangnam Severance Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Recurrence-free intervalthrough study completion, an average of 5 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026