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.
Sex: female
Age: 20 years and older
Patients with no clinical/radiologic distant metastasis
Tumor type: Invasive ductal carcinoma
Multifocal lesion (≥2)
Extent of residual microcalcification after neoadjuvant chemotherapy > 2cm
Bilateral breast cancer or inflammatory breast cancer
Contraindication to radiotherapy
Single group
Breast surgery omission
Procedure/SurgeryFor 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.
Disease-Free Survival
Proportion of patients with no disease recurrence (including loco-regional recurrence, distant metastasis, and contralateral breast cancer) or death.
Ipsilateral Breast Tumor Recurrence-Free Survival Ipsilateral Breast Tumor Recurrence-Free Survival
Proportion of patients with no disease recurrence in the ipsilateral breast or death
Overall Survival
Proportion of patients with no death.
Invasive Disease-Free Survival Invasive Disease-Free Survival
Proportion of patients with no invasive disease recurrence (including loco-regional recurrence, distant metastasis, and contralateral breast cancer) or death.
QoL, symptoms, and medical cost
Analysis of QoL survey (BREAST-Q), procedure-related symptoms, and medical cost
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Seoul National University Hospital
Lead sponsor
Ministry of Health & Welfare, Korea
Collaborator
