Non-inferiority Study in Patients With Complete Pathological Response After Neoadjuvant Chemotherapy and Negative VABB Biopsy Undergoing RT Alone, Omitting Surgical Treatment

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Istituto di Candiolo IRCCS
NOT_YET_RECRUITING
Candiolo
European Institute of Oncology
RECRUITING
Milan
Contact Information
Primary
Elisabetta Rossi, MD
ElisabettaMariaCristina.Rossi@ieo.it
+39-0294372191
Time Frame
Start Date: 2023-12-11
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 77
Treatments
Experimental: Omission of surgical treatment
Omission of surgical treatment in patients with complete pathological response after neoadjuvant chemotherapy and negative VABB biopsy
Related Therapeutic Areas
Sponsors
Leads: European Institute of Oncology

This content was sourced from clinicaltrials.gov