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
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
- 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.
Primary outcomes
- Disease-Free Survival (5 years after axillary surgery or VAB (in case of axillary surgery omission))
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
- Seoul National University Hospital, Seoul, South Korea
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.