OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk

NCT05333328 — Phase 4, Recruiting, 418 participants, Gangnam Severance Hospital

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

Registry	NCT05333328, acronym INTERSTELLAR
Status	Recruiting
Phase	Phase 4
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	418 (Estimated)
Sponsor	Gangnam Severance Hospital (Other); collaborators: Seoul National University
Conditions	Breast Cancer, Estrogen Receptor Positive Tumor, HER2-negative Breast Cancer, Premenopausal Breast Cancer, Node-positive Breast Cancer
Interventions	Ovarian function suppression with endocrine treatments (Drug)
Dates	start 2023-02-06, primary completion 2031-01-01 (estimated), completion 2033-01-01 (estimated), first posted 2022-04-18, last updated 2025-05-22
Locations	2 sites in South Korea

-Summary

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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
OFS with endocrine	Experimental	Drug: Ovarian function suppression with endocrine treatments	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.

Ovarian function suppression with endocrine treatments (Drug): * 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.

+Outcome measures

Primary outcomes

Distant recurrence-free survival [5-years distant recurrence-free survival]: The interval between the date of primary surgery and the date of last censored, or distant recurrence or death of any cause

Secondary outcomes

Recurrence-free survival (RFS) [5-years RFS]: The interval between the date of primary surgery and the date of last censored, or any type of recurrence or death of any cause
Invasive disease-free survival (iDFS) [5-years iDFS]: The interval between the date of primary surgery and the date of last censored, or any type of invasive disease except thyroid cancer or death of any cause

+Eligibility

Sex: Female, ages: 20 Years to 50 Years

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

+Locations (2)

Facility	City	Country	Status
Gangnam Severance Hospital	Seoul, Korea	South Korea	Recruiting
Seoul National University Hospital	Seoul	South Korea	Not yet recruiting

+Publications

Results publication: 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 Feb;29(1):81-89. doi: 10.4048/jbc.2025.0181. Epub 2026 Jan 30. PMID 41612658

+Investigators

Sung Gwe Ahn, M.D.,Ph.D., Principal investigator, Gangnam Severance Hospital

My Notes

Public

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