Vabb After Neoadjuvant Therapy to Avoid Surgery-pCR to Avoid Breast Surgery
Non-inferiority Study in Patients With Complete Pathological Response After Neoadjuvant Chemotherapy and Negative VABB Biopsy Undergoing RT Alone, Omitting Surgical Treatment
European Institute of Oncology
77 participants
Dec 11, 2023
INTERVENTIONAL
Conditions
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 Criteria7
- 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 Criteria6
- 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
Interventions
Omission of surgery in patients with pCR after neoadjuvant chemotherapy and negative VABB biopsy
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06281210