Actively Recruiting

Phase 4
Age: 20Years - 50Years
FEMALE
NCT05333328

OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk

Led by Gangnam Severance Hospital · Updated on 2025-05-22

418

Participants Needed

2

Research Sites

516 weeks

Total Duration

On this page

Sponsors

G

Gangnam Severance Hospital

Lead Sponsor

S

Seoul National University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk

Who Can Participate

Age: 20Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with estrogen receptor-positive, HER2-negative breast cancer
  • Premenopausal and aged 50 years or younger
  • Tumor size classified as T1 or T2
  • Cancer present in lymph nodes classified as N1, including micrometastasis
  • Genomic low risk score (1-20) based on OncoFREE4 multigene test
Not Eligible

You will not qualify if you...

  • Postmenopausal women
  • Women with estrogen receptor-negative breast cancer

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Gangnam Severance Hospital

Seoul, Korea, South Korea, 06229

Actively Recruiting

2

Seoul National University Hospital

Seoul, South Korea

Not Yet Recruiting

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Research Team

S

Sung Gwe Ahn, M.D.,Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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