Non-inferiority Study in Patients With Complete Pathological Response After Neoadjuvant Chemotherapy and Negative VABB Biopsy Undergoing RT Alone, Omitting Surgical Treatment
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.
• age\> 18 years
• infiltrating breast carcinoma, non-special histotype, triple negative or HER2 +, T1-T2 N0
• single lesion
• neo-adjuvant chemotherapy treatment for at least 12 weeks according to clinical practice
• conservative surgery proposal
• M0
• tumour bed identified by breast markers placed in pre NACT by radiologist