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

NCT06281210 | Recruiting

• 1 other identifier: IEO 2034
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 2

Brief 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

Breast Cancer; Triple Negative Breast Cancer; HER2-positive Breast Cancer; Neoadjuvant Chemotherapy

Keywords

Triple negative breast cancer; HER2-positive breast cancer; neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• Event-free survival

  Absence of disease recurrence or progression, second primary tumor, or death

  5 years

Secondary Outcomes (2)

• Positive predictive value of MRI

  6 months

• Contrast-Enhanced Mammography (CEM) positive predictive value

  6 months

Study Arms (1)

Omission of surgical treatment

EXPERIMENTAL

Omission of surgical treatment in patients with complete pathological response after neoadjuvant chemotherapy and negative VABB biopsy

Procedure: Omission of surgical treatment

Interventions

Omission of surgical treatment PROCEDURE

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

Omission of surgical treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• tumour bed identified by breast markers placed in pre NACT by radiologist

You may not qualify if:

• 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

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (2)

Istituto di Candiolo IRCCS

Candiolo, Turin, 10060, Italy

NOT YET RECRUITING

European Institute of Oncology

Milan, 20141, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Elisabetta Rossi, MD

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisabetta Rossi, MD

CONTACT

+39-0294372191; ElisabettaMariaCristina.Rossi@ieo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start: December 11, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

IT (2)