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Refusal of Breast Surgery in Patients With Breast Cancer With a Clinical Complete Response (cCR) After Neoadjuvant Systemic Therapy and a Confirmed Pathological Complete Response (pCR) Using Vacuum-assisted Biopsy (VAB) and Sentinel Lymph Node Biopsy (SLNB)
Sponsor: N.N. Petrov National Medical Research Center of Oncology
Summary
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.
Key Details
Gender
FEMALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2019-10-08
Completion Date
2028-12-10
Last Updated
2022-06-15
Healthy Volunteers
No
Interventions
Vacuum-assisted biopsy
The 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.
Locations (1)
Petr Krivorotko
Saint Petersburg, Russia