Trials / Recruiting
RecruitingNCT05333328
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)
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 418 (estimated)
- Sponsor
- Gangnam Severance Hospital · Academic / Other
- Sex
- Female
- Age
- 20 Years – 50 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
* 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 (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.
Conditions
- Breast Cancer
- Estrogen Receptor Positive Tumor
- HER2-negative Breast Cancer
- Premenopausal Breast Cancer
- Node-positive Breast Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-02-06
- Primary completion
- 2031-01-01
- Completion
- 2033-01-01
- First posted
- 2022-04-18
- Last updated
- 2025-05-22
Locations
2 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT05333328. Inclusion in this directory is not an endorsement.