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RECRUITING
NCT05505357
NA

Omission of Breast Surgery for Breast Cancer Patients With pCR on MRI and Vacuum-assisted Biopsy After NST (OPTIMIST)

Sponsor: Seoul National University Hospital

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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