NCT07093775

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2025

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 30, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

July 30, 2025

Status Verified

June 1, 2025

Enrollment Period

5 months

First QC Date

July 15, 2025

Last Update Submit

July 22, 2025

Conditions

Breast CancerTumor Grade

Outcome Measures

Primary Outcomes (1)

  • Recurrence-free interval

    through study completion, an average of 5 year

Interventions

Tumor grade (I or II vs. III)OTHER

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

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with HR-positive, HER2-negative breast cancer who were node-negative and underwent curative surgery followed by 21-gene Oncotype DX testing

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

vasectrin III

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 15, 2025

First Posted

July 30, 2025

Study Start

July 1, 2025

Primary Completion

December 1, 2025

Study Completion

March 1, 2026

Last Updated

July 30, 2025

Record last verified: 2025-06