Clinical trial · Interventional
OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk
Endocrine Therapies With Ovarian Function Suppression in Premenopausal Node+ Early Breast Cancer With Low Genomic Risk (INTERSTELLAR Trial, KBCSG-25)
NCT05333328CI-TRIAL-00090063INTERSTELLARrecruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Estrogen Receptor Positive Tumor | — | UNRESOLVED | — |
| HER2-negative Breast Cancer | — | UNRESOLVED | — |
| Node-positive Breast Cancer | — | UNRESOLVED | — |
| Premenopausal Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ovarian function suppression with endocrine treatments | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OFS with endocrine
- description
- 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.
- interventionNames
- Drug: Ovarian function suppression with endocrine treatments
Primary outcomes (1)
- measure
- Distant recurrence-free survival
- timeFrame
- 5-years distant recurrence-free survival
- description
- The interval between the date of primary surgery and the date of last censored, or distant recurrence or death of any cause
Secondary outcomes (2)
- measure
- Recurrence-free survival (RFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDAhn 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 Feb;29(1):81-89. doi: 10.4048/jbc.2025.0181. Epub 2026 Jan 30. PMID 41612658