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
Bilateral or multicentric tumour
Presence of microcalcifications visualised on mammography
Presence of associated DCIS
Positive history of previous breast cancer
Single group
Omission of surgical treatment
Procedure/SurgeryOmission of surgery in patients with pCR after neoadjuvant chemotherapy and negative VABB biopsy
Event-free survival
Absence of disease recurrence or progression, second primary tumor, or death
Positive predictive value of MRI
Evaluation of the accuracy of breast MRI in predicting pCR following NACT
Contrast-Enhanced Mammography (CEM) positive predictive value
Evaluation of the accuracy of breast CEM in predicting pCR following NACT
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