RecruitingPhase 4NCT05333328

OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk

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

Sponsor

Gangnam Severance Hospital

Enrollment

418 participants

Start Date

Feb 6, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Node-positive Breast Cancer HER2-negative Breast Cancer Estrogen Receptor Positive Tumor Premenopausal Breast Cancer

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.

Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 50 Years

Inclusion Criteria5

ER+HER2- breast cancer
Premenopausal and age \<=50
T1 or T2
N1 including micrometastasis
Genomic Low Risk by OncoFREE test® (1-20)

Exclusion Criteria2

Postmenopausal women
ER-negative breast cancer

Interventions

DRUGOvarian function suppression with endocrine treatments

* 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.