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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20+
SponsorSeoul National University Hospital

About this trial

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 criteria

Qualifiers

Sex: female

Age: 20 years and older

Patients with no clinical/radiologic distant metastasis

Tumor type: Invasive ductal carcinoma

Disqualifiers

Multifocal lesion (≥2)

Extent of residual microcalcification after neoadjuvant chemotherapy > 2cm

Bilateral breast cancer or inflammatory breast cancer

Contraindication to radiotherapy

Trial design

Treatments tested in this trial

  • Breast surgery omission

Treatment groups

533 Participants
are divided into 1 treatment group

Sponsors and collaborators

Seoul National University Hospital

Lead sponsor

Ministry of Health & Welfare, Korea

Collaborator