NCT05333328 OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk
| NCT ID | NCT05333328 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Gangnam Severance Hospital |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 418 participants |
| Start Date | 2023-02-06 |
| Primary Completion | 2031-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 418 participants in total. It began in 2023-02-06 with a primary completion date of 2031-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * ER+HER2- breast cancer * Premenopausal and age \<=50 * T1 or T2 * N1 including micrometastasis * Genomic Low Risk by OncoFREE test® (1-20) Exclusion Criteria: * Postmenopausal women * ER-negative breast cancer
Contact & Investigator
Sung Gwe Ahn, M.D.,Ph.D.
PRINCIPAL INVESTIGATOR
Gangnam Severance Hospital
Frequently Asked Questions
Who can join the NCT05333328 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 50 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05333328 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05333328 currently recruiting?
Yes, NCT05333328 is actively recruiting participants. Contact the research team at asg2004@yuhs.ac for enrollment information.
Where is the NCT05333328 trial being conducted?
This trial is being conducted at Seoul, South Korea, Seoul, South Korea.
Who is sponsoring the NCT05333328 clinical trial?
NCT05333328 is sponsored by Gangnam Severance Hospital. The principal investigator is Sung Gwe Ahn, M.D.,Ph.D. at Gangnam Severance Hospital. The trial plans to enroll 418 participants.
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