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

NCT06281210 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2024-02-28

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Omission of surgical treatment

Omission of surgery in patients with pCR after neoadjuvant chemotherapy and negative VABB biopsy

Sponsors & Collaborators

  • European Institute of Oncology

    lead OTHER

Principal Investigators

  • Elisabetta Rossi, MD · European Institute of Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-11
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06281210 on ClinicalTrials.gov