Ovarian function suppression for premenopausal women with low-risk breast cancer
Endocrine Therapies With Ovarian Function Suppression in Premenopausal Node+ Early Breast Cancer With Low Genomic Risk (INTERSTELLAR Trial, KBCSG-25)
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 |
| Enrollment | 418 (estimated) |
| Ages | 20 Years to 50 Years |
| Sex | Female |
| Sponsor | Gangnam Severance Hospital Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 2 sites (Seoul, Korea and 1 other locations) |
| Trial ID | NCT05333328 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are premenopausal women aged 50 or younger with ER+HER2- breast cancer and low genomic risk.
Not a fit: Patients who are postmenopausal or have ER-negative breast cancer will not benefit from this study.
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 performed: Other studies have shown promise in using ovarian function suppression in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
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 this trial is running
Seoul, Korea and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.