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OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk

NCT05333328 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 418

Last updated 2025-05-22

No results posted yet for this study

Summary

Among ER+HER2- premenopausal patients with N1 who undergoes primary breast surgery, we will identify the patients with a genomic low risk using the multigene-assay (OncoFREE®).

In these, ovarian function suppression with endocrine therapies including either tamoxifen or aromatase-inhibitors will be administered for 5 years.

Conditions

Interventions

DRUG

Ovarian function suppression with endocrine treatments

* Ovarian function suppression (OFS) with endocrine therapies including either tamoxifen or aromatase-inhibitors will be administered for 5 years. * Either goserelin acetate or leuprorelin Acetate is allowed. * These patients are able to choose bilateral salpingo-oophorectomy instead of OFS. * Chemotherapy is omitted in these patients.

Sponsors & Collaborators

  • Seoul National University

    collaborator OTHER

  • Gangnam Severance Hospital

    lead OTHER

Principal Investigators

  • Sung Gwe Ahn, M.D.,Ph.D. · Gangnam Severance Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-06
Primary Completion
2031-01-31
Completion
2033-01-31

Countries

  • South Korea

Study Locations

More Related Trials

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 NCT05333328 on ClinicalTrials.gov