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Vabb After Neoadjuvant Therapy to Avoid Surgery-pCR to Avoid Breast Surgery
Sponsor: European Institute of Oncology
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.
Official title: Non-inferiority Study in Patients With Complete Pathological Response After Neoadjuvant Chemotherapy and Negative VABB Biopsy Undergoing RT Alone, Omitting Surgical Treatment
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
77
Start Date
2023-12-11
Completion Date
2028-12-31
Last Updated
2024-02-28
Healthy Volunteers
No
Conditions
Interventions
Omission of surgical treatment
Omission of surgery in patients with pCR after neoadjuvant chemotherapy and negative VABB biopsy
Locations (2)
Istituto di Candiolo IRCCS
Candiolo, Turin, Italy
European Institute of Oncology
Milan, Italy