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RECRUITING
NCT05333328
PHASE4

OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk

Sponsor: Gangnam Severance Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

20 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

418

Start Date

2023-02-06

Completion Date

2033-01

Last Updated

2025-05-22

Healthy Volunteers

No

Interventions

DRUG

Ovarian 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.

Locations (2)

Gangnam Severance Hospital

Seoul, Korea, South Korea

Seoul National University Hospital

Seoul, South Korea