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
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
• 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