OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ovarian function suppression with endocrine treatments.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Estrogen Receptor Positive Tumor, HER2-negative Breast Cancer, Premenopausal Breast Cancer. Basic parameters: 20 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Endocrine Therapies With Ovarian Function Suppression in Premenopausal Node+ Early Breast Cancer With Low Genomic Risk (INTERSTELLAR Trial, KBCSG-25)
Overview
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.
Interventions
- Drug Ovarian function suppression with endocrine treatments
* 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.
Primary outcome measures
- Distant recurrence-free survival [Time frame: 5-years distant recurrence-free survival]
Secondary outcome measures (2)
- Recurrence-free survival (RFS) [Time frame: 5-years RFS]
- Invasive disease-free survival (iDFS) [Time frame: 5-years iDFS]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 2 centers
- Gangnam Severance Hospital — Seoul
- Seoul National University Hospital — Seoul
Publications
- 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 PMID 41612658
Identifiers
NCT: NCT05333328 · 2021-1151-002