Ireland
--:--IST
Recruiting Phase 4

OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk

NCT05333328 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 4
Started
2023-02-06
Last updated
2025-05-22

Condition(s) studied

Breast CancerEstrogen Receptor Positive TumorHER2-negative Breast CancerPremenopausal Breast CancerNode-positive Breast Cancer

Investigational drug(s) / intervention(s)

Ovarian function suppression with endocrine treatments

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.

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.

Eligibility

Sex
FEMALE
Min age
20 Years
Max age
50 Years
Healthy volunteers
No
Inclusion Criteria: * ER+HER2- breast cancer * Premenopausal and age \<=50 * T1 or T2 * N1 including micrometastasis * Genomic Low Risk by OncoFREE test® (1-20) Exclusion Criteria: * Postmenopausal women * ER-negative breast cancer

Primary outcome measure(s)

  • Distant recurrence-free survival — 5-years distant recurrence-free survival
    The interval between the date of primary surgery and the date of last censored, or distant recurrence or death of any cause

Trial sites (2)

FacilityCityRegionStatus
Gangnam Severance Hospital Seoul Korea Recruiting
Seoul National University Hospital Seoul South Korea Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05333328 on ClinicalTrials.gov ↗ ← All trials in South Korea