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Endocrine Therapies With Ovarian Function Suppression in Premenopausal Node+ Early Breast Cancer With Low Genomic Risk (INTERSTELLAR Trial, KBCSG-25)
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.
* 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.
Age
20 - 50 years
Sex
FEMALE
Healthy Volunteers
No
Gangnam Severance Hospital
Seoul, Korea, South Korea
Seoul National University Hospital
Seoul, South Korea
Start Date
February 6, 2023
Primary Completion Date
January 1, 2031
Completion Date
January 1, 2033
Last Updated
May 22, 2025
418
ESTIMATED participants
Ovarian function suppression with endocrine treatments
DRUG
Lead Sponsor
Gangnam Severance Hospital
Collaborators
NCT04704661
NCT04550494
Data Source & Attribution
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