OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk

Recruiting now · Phase 4

Conditions studied: Breast Cancer, Estrogen Receptor Positive Tumor, HER2-negative Breast Cancer, Premenopausal Breast Cancer, Node-positive Breast Cancer

In brief

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.

Key facts

Study ID

NCT05333328

Run by

Gangnam Severance Hospital

People needed

418

Starts

2023-02-06

Expected to finish

2033-01-01

Last updated by the study team

2025-05-22

Who can join

Age: 20 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• ER+HER2- breast cancer
• Premenopausal and age <=50
• T1 or T2
• N1 including micrometastasis
• Genomic Low Risk by OncoFREE test® (1-20)

You may not qualify if…

• Postmenopausal women
• ER-negative breast cancer

Where it is running

• Gangnam Severance Hospital — Seoul, Korea, South Korea (enrolling)
• Seoul National University Hospital — Seoul, South Korea

Full record on ClinicalTrials.gov

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