About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Bilateral or multicentric tumour
Presence of microcalcifications visualised on mammography
Presence of associated DCIS
Positive history of previous breast cancer
Trial design
Treatments tested in this trial
- Omission of surgical treatment