NCT05333328

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
418

participants targeted

Target at P75+ for phase_4 breast-cancer

Timeline
81mo left

Started Feb 2023

Longer than P75 for phase_4 breast-cancer

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Feb 2023Jan 2033

First Submitted

Initial submission to the registry

April 11, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 18, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

February 6, 2023

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2031

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2033

Last Updated

May 22, 2025

Status Verified

May 1, 2025

Enrollment Period

7.9 years

First QC Date

April 11, 2022

Last Update Submit

May 18, 2025

Conditions

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

Keywords

Breast CancerEstrogen Receptor Positive TumorHER2-negative Breast CancerPremenopausal Breast CancerNode-positive Breast CancerMultigene assayOvarian-function suppression

Outcome Measures

Primary Outcomes (1)

  • 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

    5-years distant recurrence-free survival

Secondary Outcomes (2)

  • Recurrence-free survival (RFS)

    5-years RFS

  • Invasive disease-free survival (iDFS)

    5-years iDFS

Study Arms (1)

OFS with endocrine

EXPERIMENTAL

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.

Drug: Ovarian function suppression with endocrine treatments

Interventions

Ovarian function suppression with endocrine treatmentsDRUG

* 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.

OFS with endocrine

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gangnam Severance Hospital

Seoul, Korea, 06229, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

NOT YET RECRUITING

Related Publications (1)

  • Ahn SG, Sim SH, Kang T, Kim EK, Lee JE, Moon HG, Ahn JH, Lim W, Youn HJ, Kim HA, Yoon CI, Kim J, Kang B, Park MH, Kang SH, Kim LS, Bae SJ, Kook Y, Lee KH, Lee HB, Han W, Park YH. Prospective Single-Arm Study of Endocrine Therapies With Ovarian Function Suppression in Premenopausal Node-Positive Early Breast Cancer Patients With Low Genomic Risk (INTERSTELLAR Trial, KBCSG-25). J Breast Cancer. 2026 Jan 30. doi: 10.4048/jbc.2025.0181. Online ahead of print.

    PMID: 41612658DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Sung Gwe Ahn, M.D.,Ph.D.

    Gangnam Severance Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

0220193370asg2004@yuhs.ac

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: De-escalating treatment as ovarian-function suppression with endocrine treatments alone in ER+HER2- premenopausal women with N1
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

April 11, 2022

First Posted

April 18, 2022

Study Start

February 6, 2023

Primary Completion (Estimated)

January 1, 2031

Study Completion (Estimated)

January 1, 2033

Last Updated

May 22, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(2)