Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
Study NCT ID:
NCT05333328
Status:
RECRUITING
Last Update Posted:
2025-05-22
First Post:
2022-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk
Sponsor:
Gangnam Severance Hospital
Organization:
Study Overview
Official Title:
Endocrine Therapies With Ovarian Function Suppression in Premenopausal Node+ Early Breast Cancer With Low Genomic Risk (INTERSTELLAR Trial, KBCSG-25)
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INTERSTELLAR
Brief 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.
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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: