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Endocrine Therapy Base on 21-gene RS

NCT07311122 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 4000

Last updated 2025-12-30

No results posted yet for this study

Summary

Among patients aged ≤50 years with hormone receptor-positive, HER2-negative breast cancer and pathologic nodal stage pN0-1-limited to those with an Oncotype DX® Recurrence Score (RS) of 11-25 for pN0 and ≤25 for pN1-, we will investigate the followings:

i) Real-world patterns of adjuvant therapy (systemic chemotherapy and endocrine therapy) and radiotherapy according to N stage and Oncotype DX® RS.

ii) Clinicopathologic characteristics of each patient subgroup by adjuvant treatment modality and RS category.

iii) Survival outcomes and independent prognostic factors according to RS. iv) Survival analyses by adjuvant treatment modality, stratified by RS category, clinical risk, and N stage.

Through these analyses, we aim to establish clinical evidence on whether endocrine therapy combined with ovarian function suppression (OFS) can substitute for adjuvant chemotherapy in HR+/HER2- patients with pN0-1 disease within the above RS ranges, and-if so-to define the patient subsets for whom this substitution is appropriate.

Conditions

Interventions

DIAGNOSTIC_TEST

Oncotype DX

All patients received Oncotype DX test.

Sponsors & Collaborators

  • Gangnam Severance Hospital

    lead OTHER

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-12-31
Completion
2028-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07311122 on ClinicalTrials.gov