Clinical Trial: NCT05333328
OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk
Status:
RECRUITINGPhase:
Phase 4| Lead Sponsor: | Gangnam Severance Hospital |
| Information Provided By: | Gangnam Severance Hospital |
| Last Update Posted: | 2025-05-22 |
Study Overview
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.
Official Title
Endocrine Therapies With Ovarian Function Suppression in Premenopausal Node+ Early Breast Cancer With Low Genomic Risk (INTERSTELLAR Trial, KBCSG-25)
Conditions
Breast Cancer, Estrogen Receptor Positive Tumor, HER2-negative Breast Cancer, Premenopausal Breast Cancer, Node-positive Breast Cancer
Intervention / Treatment
- Drug: Ovarian function suppression with endocrine treatments
Other Study ID Numbers
- 2021-1151-002
Start Date (Actual)
2023-02-06
Primary Completion Date (Estimated)
2031-01
Study Completion Date (Estimated)
2033-01
Enrollment (Estimated)
418
Study Type
Interventional
Phase
Phase 4
| Lead Sponsor: | Gangnam Severance Hospital |
| Information Provided By: | Gangnam Severance Hospital |
| Last Update Posted: | 2025-05-22 |
Study Overview
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.
Official Title
Endocrine Therapies With Ovarian Function Suppression in Premenopausal Node+ Early Breast Cancer With Low Genomic Risk (INTERSTELLAR Trial, KBCSG-25)
Conditions
Breast Cancer, Estrogen Receptor Positive Tumor, HER2-negative Breast Cancer, Premenopausal Breast Cancer, Node-positive Breast Cancer
Intervention / Treatment
- Drug: Ovarian function suppression with endocrine treatments
Other Study ID Numbers
- 2021-1151-002
Start Date (Actual)
2023-02-06
Primary Completion Date (Estimated)
2031-01
Study Completion Date (Estimated)
2033-01
Enrollment (Estimated)
418
Study Type
Interventional
Phase
Phase 4