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Omission of Breast Surgery for Breast Cancer Patients With pCR on MRI and Vacuum-assisted Biopsy After NST (OPTIMIST)
Sponsor: Seoul National University Hospital
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.
Official title: Omission of Breast Surgery for Predicted Pathologic Complete Response Patients With MRI and Vacuum-assisted bIopsy in Breast Cancer After Neoadjuvant Systemic Therapy: a Multicenter, Single-arm, Non-inferiority Trial
Key Details
Gender
FEMALE
Age Range
20 Years - Any
Study Type
INTERVENTIONAL
Enrollment
533
Start Date
2022-09-22
Completion Date
2031-06
Last Updated
2024-02-28
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Seoul National University Hospital
Seoul, South Korea