NCT05333328RecruitingPhase 4
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)
Source: ClinicalTrials.gov · Last updated 22 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 418 (estimated)
- First submitted
- 11 Apr 2022
- Start date
- 6 Feb 2023
- Primary completion date
- 31 Jan 2031
- Lead sponsor
- Gangnam Severance Hospital
- Diseases
- Ovarian cancer
- NCT number
- NCT05333328
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 418
- From 6 Feb 2023 to the primary completion date, 31 Jan 2031
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- ER-negative breast cancer
Other
- Postmenopausal women
Who the study is looking for
- ER+HER2- breast cancer
- Premenopausal and age \<=50
- T1 or T2
- N1 including micrometastasis
- Genomic Low Risk by OncoFREE test® (1-20)
Age in the registry: 20 years to 50 years · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gangnam Severance Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.