Recruiting

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

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.

ClinicalTrials.gov IDNCT05505357
PhaseNA
Enrollment533
SponsorSeoul National University Hospital
Age20 Years
SexFEMALE
I'm interested View official listing

Conditions studied

Breast Cancer Invasive

About this study

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.

Interventions

Primary outcomes

Eligibility information

Inclusion Criteria: * Sex: female * Age: 20 years and older * Patients with no clinical/radiologic distant metastasis * Tumor type: Invasive ductal carcinoma * Tumor subtype: HER2 positive(including luminal B type, triple negative * Extent of disease: initial tumor size ≤ 5cm, cN0-2 * Patients with measurable tumor size * Patients who are expected to achieve pCR after neoadjuvant chemotherapy (MRI size ≤ 1.0 cm AND L-to-B SER ≤ 1.6) * Patients with clip inserted to the primary tumor site before or during neoadjuvant chemotherapy * Patients with informed consent who are competent to make a voluntary decision Exclusion Criteria: * Multifocal lesion (≥2) * Extent of residual microcalcification after neoadjuvant chemotherapy \> 2cm * Bilateral breast cancer or inflammatory breast cancer * Contraindication to radiotherapy * History of previous contralateral breast cancer * Breast cancer patients with distant metastasis * Allergic history to MRI contrast * Male breast cancer * Patients incapable of giving informed consent owing to poor general conditions * Patients with BRCA mutation * Patients willing to receive breast surgery * Patients with a history of cancer diagnosis within 5 years (However, skin cancer other than melanoma and breast carcinoma in situ other than ductal carcinoma in situ can be registered even if 5 years have not passed since the diagnosis)

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-29.