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| Name | Class |
|---|---|
| Seoul National University | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OFS with endocrine | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ovarian function suppression with endocrine treatments | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5-years distant recurrence-free survival |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-free survival (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 | 5-years RFS |
| Invasive disease-free survival (iDFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sung Gwe Ahn, M.D.,Ph.D. | Contact | 0220193370 | asg2004@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Sung Gwe Ahn, M.D.,Ph.D. | Gangnam Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gangnam Severance Hospital | Recruiting | Seoul | Korea | 06229 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41612658 | Derived | 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. |
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De-escalating treatment as ovarian-function suppression with endocrine treatments alone in ER+HER2- premenopausal women with N1
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|
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
| 5-years iDFS |
| Seoul National University Hospital | Not yet recruiting | Seoul | South Korea |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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