Endocrine Therapies With Ovarian Function Suppression in Premenopausal Node+ Early Breast Cancer With Low Genomic Risk (INTERSTELLAR Trial, KBCSG-25)
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 50
Healthy Volunteers: f
View:
• ER+HER2- breast cancer
• Premenopausal and age \<=50
• T1 or T2
• N1 including micrometastasis
• Genomic Low Risk by OncoFREE test® (1-20)
Locations
Other Locations
Republic of Korea
Gangnam Severance Hospital
RECRUITING
Seoul
Seoul National University Hospital
NOT_YET_RECRUITING
Seoul
Contact Information
Primary
Sung Gwe Ahn, M.D.,Ph.D.
asg2004@yuhs.ac
0220193370
Time Frame
Start Date: 2023-02-06
Estimated Completion Date: 2033-01
Participants
Target number of participants: 418
Treatments
Experimental: OFS with endocrine
Among ER+HER2- premenopausal patients with N1 who undergoes primary breast surgery, the patients with a genomic low risk using the multigene-assay (OncoFREE®) will be included in this arm.
Related Therapeutic Areas
Sponsors
Leads: Gangnam Severance Hospital
Collaborators: Seoul National University