Actively Recruiting

Phase 4
Age: 20Years - 50Years
FEMALE
ID05333328

Endocrine Therapies With Ovarian Function Suppression in Premenopausal Node+ Early Breast Cancer With Low Genomic Risk (INTERSTELLAR Trial, KBCSG-25)

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

418

Participants Needed

2

Research Sites

104 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

This research evaluates premenopausal women with estrogen receptor-positive (ER+) and HER2-negative breast cancer who have cancer spread to nearby lymph nodes (N1). The study focuses on patients who have undergone primary breast surgery and are identified as having a low genomic risk based on the OncoFREE4 multigene assay. The goal is to study the effects of ovarian function suppression combined with endocrine therapies in this specific group. Participants will receive ovarian function suppression (OFS) with endocrine treatments, which includes either tamoxifen or aromatase inhibitors, administered over a period of 5 years. The OFS may be delivered using drugs such as goserelin acetate or leuprorelin acetate. Alternatively, patients may choose to undergo bilateral salpingo-oophorectomy instead of OFS. Chemotherapy is not given to these patients. During the study, participants will be monitored for outcomes including distant recurrence-free survival over 5 years, as well as recurrence-free survival and invasive disease-free survival. Researchers will assess these outcomes to understand the long-term effects of the treatments. The total participation time aligns with the 5-year treatment period, with ongoing safety and disease status assessments throughout.

CONDITIONS

Brief 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...

  • Estrogen receptor-positive, HER2-negative breast cancer
  • Premenopausal women aged 50 years or younger
  • Tumor size classified as T1 or T2
  • Lymph node involvement classified as N1 including micrometastasis
  • Low genomic risk score (1-20) by OncoFREE test4
  • Have undergone primary breast surgery
Not Eligible

You will not qualify if you...

  • Postmenopausal women
  • Estrogen receptor-negative breast cancer
  • Women older than 50 years

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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3
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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 5 years

Participants receive ovarian function suppression with endocrine therapies including either tamoxifen or aromatase-inhibitors for five years. They may choose between medication or bilateral salpingo-oophorectomy as part of their treatment.

Regular visits to monitor treatment and health status over 5 years

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.

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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Frequently Asked Questions

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Published Research Related To This Trial

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).

Sung Gwe Ahn, Sung Hoon Sim, Taewoo Kang...

https://pubmed.ncbi.nlm.nih.gov/41612658