Ovarian function suppression for premenopausal women with low-risk breast cancer
Official title: Endocrine Therapies With Ovarian Function Suppression in Premenopausal Node+ Early Breast Cancer With Low Genomic Risk (INTERSTELLAR Trial, KBCSG-25)
Run by Gangnam Severance Hospital · NCT05333328 · Data updated 2026-11-12
This study is testing if lowering ovarian function with hormone treatments can help premenopausal women with low-risk breast cancer after surgery feel better and avoid chemotherapy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 20 Years to 50 Years |
| Sex | Women only |
| Enrollment | 418 (estimated) |
| Sponsor | Gangnam Severance Hospital Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 2 sites (Seoul, Korea and 1 other locations) |
| Status | Recruiting |
| Started | February 6, 2023 |
| Main results expected | January 2031 |
| Study ends | January 2033 |
| Registry record updated | May 22, 2025 |
| Trial ID | NCT05333328 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are premenopausal women aged 50 or younger with ER+HER2- breast cancer and low genomic risk.
✕Probably not a fit
Patients who are postmenopausal or have ER-negative breast cancer will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial focuses on premenopausal women with estrogen receptor-positive, HER2-negative breast cancer who have undergone primary breast surgery. It aims to identify patients with low genomic risk using the OncoFREE multigene assay. Eligible participants will receive ovarian function suppression through endocrine therapies, such as tamoxifen or aromatase inhibitors, for a duration of five years. The study also allows for the option of bilateral salpingo-oophorectomy instead of ovarian function suppression, while omitting chemotherapy for these patients.
Why it matters
Potential benefit: If successful, this approach could provide a less aggressive treatment option for premenopausal women with low-risk breast cancer, potentially improving quality of life.
How similar studies have gone: Other studies have shown promise in using ovarian function suppression in similar patient populations, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Gangnam Severance Hospital
Seoul, Korea, South Korea Recruiting -
Seoul National University Hospital
Seoul, South Korea Not yet recruiting
Study contacts
- Principal investigator: Sung Gwe Ahn, M.D.,Ph.D. — Gangnam Severance Hospital
- Study coordinator: Sung Gwe Ahn, M.D.,Ph.D.
- Email: asg2004@yuhs.ac
- Phone: 0220193370
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.