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RECRUITING
NCT06281210
NA

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

Sponsor: European Institute of Oncology

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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