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

Summary

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

Inclusion Criteria:

* 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

Exclusion Criteria:

* Bilateral or multicentric tumour
* Presence of microcalcifications visualised on mammography
* Presence of associated DCIS
* Positive history of previous breast cancer
* Positive history of medical or psychiatric conditions preventing adherence to the protocol
* High risk patient

Conditions5

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