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

Study acronym: BETTY-CRASY
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT06281210
Lead Sponsor European Institute of Oncology
Conditions
(from sponsor)		 Breast Cancer, Triple Negative Breast Cancer, HER2-positive Breast Cancer, Neoadjuvant Chemotherapy
Related terms Breast Neoplasms, Triple Negative Breast Neoplasms
Enrollment 77 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov