Vabb After Neoadjuvant Therapy to Avoid Surgery-pCR to Avoid Breast Surgery

This single arm study aims to evaluate the efficacy and safety of a non-surgical approach, consisting of radiotherapy (RT) alone, for patients who have achieved a complete pathological response (pCR) following neoadjuvant chemotherapy (NACT). The study design involves the histological confirmation of pCR using vacuum-assisted biopsy (VABB) or vacuum-assisted excision (VAE) guided by ultrasound. The primary objective is to demonstrate that the non-surgical, RT-only treatment and follow-up approach is not inferior to the traditional surgical approach in patients with pCR after NACT.

NCT Number	NCT06281210
Lead Sponsor	European Institute of Oncology
Conditions	Breast Cancer, Triple Negative Breast Cancer, HER2-positive Breast Cancer, Neoadjuvant Chemotherapy
Enrollment	77 participants
Start Date	2023-12-11
Primary Completion	2028-12-31 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2024-02-28