The main goal of the study is to abandon breast surgery in patients with breast cancer with a clinical complete response (cCR) after neoadjuvant systemic therapy and confirmed pCR using Vacuum-assisted biopsy (VAB) and sentinel lymph node biopsy (SLNB).
Evidence of the high diagnostic accuracy (sensitivity and specificity) of vacuum aspiration biopsy in determining pCR in patients with clinical complete response after neoadjuvant systemic therapy will allow abandoning breast surgery in favor of radiation therapy alone, improving the quality of life of these patients.
age> 18 years.
morphologically confirmed diagnosis of breast cancer, IIA-IIIA stage
ECOG score 0-1.
life expectancy of more than 3 months.
Inconsistency with inclusion criteria.
Conducting earlier any systemic therapy for breast cancer.
stage 4 cancer
carrier mutations of the BRCA1 / 2 gene
Single group
Vacuum-assisted biopsy
Procedure/SurgeryThe vacuum-assisted (7-10G), minimal invasive biopsy (VAB), either guided by ultrasound, after neoadjuvant systemic treatment on patients with clinical complete response on primary breast cancer management we recommend to take at least 12 biopsies with 7-10G needle sizes with sentinel lymph node biopsy.
False negative rate of vacuum-assisted biopsy (FNR)
Achieving a false-negative rate (FNR) of less than 15% in the surgical and vacuum-assisted biopsy specimens
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