Spots Global Cancer Trial Database for OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk

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Trial Identification

Brief Title: OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk

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

Study ID: NCT05333328

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

Study Description

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.

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.