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

NCT ID: NCT07093775

Last Updated: 2025-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-31

Study Completion Date

2026-03-31

Brief Summary

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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

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Conditions

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Breast Cancer Tumor Grade

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Tumor grade (I or II vs. III)

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gangnam Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sung Gwe Ahn

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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3-2025-0107

Identifier Type: -

Identifier Source: org_study_id

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