OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk

Phase 4

Recruiting

• Conditions: Breast Cancer; Estrogen Receptor Positive Tumor; HER2-negative Breast Cancer; Premenopausal Breast Cancer; Node-positive Breast Cancer
• Interventions: Drug: Ovarian function suppression with endocrine treatments

• Registration Number: NCT05333328
• Lead Sponsor: Gangnam Severance Hospital

Brief 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.

Detailed Description

* 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 (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 Timeline

• Study First Submitted: 2022-04-11
• Study First Submitted QC: 2022-04-11
• Study First Posted: 2022-04-18
• Study Start: 2023-02-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-18
• Last Update Posted: 2025-05-22
• Primary Completion: 2031-01
• Study Completion: 2033-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 418

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OFS with endocrine	Ovarian function suppression with endocrine treatments	Among ER+HER2- premenopausal patients with N1 who undergoes primary breast surgery, the patients with a genomic low risk using the multigene-assay (OncoFREE®) will be included in this arm.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Recurrence-free survival (RFS)	5-years RFS	The interval between the date of primary surgery and the date of last censored, or any type of recurrence or death of any cause
Invasive disease-free survival (iDFS)	5-years iDFS	The interval between the date of primary surgery and the date of last censored, or any type of invasive disease except thyroid cancer or death of any cause

Trial Locations

Locations (2)

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of