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

NCT05333328 Phase 4 RECRUITING

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.

Details

Lead sponsor	Gangnam Severance Hospital
Phase	Phase 4
Status	RECRUITING
Enrolment	418
Start date	2023-02-06
Completion	2033-01

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

Primary outcomes

• Distant recurrence-free survival — 5-years distant recurrence-free survival
  The interval between the date of primary surgery and the date of last censored, or distant recurrence or death of any cause

Countries

South Korea