Omission of Breast Surgery for Breast Cancer Patients With pCR on MRI and Vacuum-assisted Biopsy After NST (OPTIMIST)
Condition(s) studied
Investigational drug(s) / intervention(s)
Breast surgery omission: For patients who are expected to achieve pathologic complete response after neoadjuvant chemotherapy based on MRI findings, vacuum-assisted biopsy will be performed on the main primary lesion marked with a clip. In case of pCR on vacuum-assisted biopsy specimen, breast surgery will be omitted.
Study summary
A prospective, multicenter, single-arm non-inferiority trial to demonstrate that breast cancer patients who are predicted to have a pathologic complete response on MRI and vacuum-assisted biopsy after neoadjuvant systemic therapy, and are omitted breast surgery have a non-inferior 5-year disease-free survival compared to those who had received breast surgery.
Eligibility
Primary outcome measure(s)
- Disease-Free Survival — 5 years after axillary surgery or VAB (in case of axillary surgery omission)
Proportion of patients with no disease recurrence (including loco-regional recurrence, distant metastasis, and contralateral breast cancer) or death.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea | Recruiting |
More Seoul National University Hospital trials in South Korea
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05505357 on ClinicalTrials.gov ↗ ← All trials in South Korea