Histology VABB-Histology Post Surgery Pilot Project (BETTY Trial)

NCT04365803 | Unknown

• 1 other identifier: IEO 0758/
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Pilot study on patients with invasive ductal breast cancer triple negative or receptor tyrosine-protein kinase erbB-2 (HER2) overexpressed, any axillary lymphnodes status (any cN), candidates to neoadjuvant chemotherapy. The principal endpoint of the study will be the accuracy of the result of the histological examination of the Vacuum- Assisted Breast Biopsy (VABB) performed pre-surgery in comparison to the result of the histological examination of the definitive surgical intervention in patients with radiological complete response at Magnetic resonance imaging (MRI) done after the end of neoadjuvant chemotherapy.

Conditions

Breast Cancer

Keywords

breast cancer; vacuum assisted breast biopsy

Outcome Measures

Primary Outcomes (1)

• Evaluation of the accuracy of histological examination of the VABB performed pre-surgery

  Identification of percentage of cases with correspondence between histology of VABB presurgery and histology of definitive surgery in patients with complete radiological response after neoadjuvant chemotherapy

  45 days

Study Arms (1)

patient with radiological complete response

patient with radiological complete response after neoadjuvant chemotherapy

Procedure: vacuum-assisted breast biopsy

Interventions

vacuum-assisted breast biopsy PROCEDURE

patient with radiological complete response after neoadjuvant chemotherapy undergo to vacuum assisted breast biopsy and the to definitive surgery

patient with radiological complete response

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with triple negative or HER2 over-expressed breast cancer with radiological complete response after neoadjuvant chemotherapy

You may qualify if:

• age ≥ 18 aa;
• histological diagnosis done at European Institute of Oncology (if not, to does revision of pathological material);
• invasive ductal breast cancer triple negative or HER2 overexpressed, any cN;
• neoadjuvant standard systemic treatment after surgery +/- trastuzumab;
• propose of conservative or demolitive surgery;
• cancer bed identified pre neoadjuvant chemotherapy by clip

You may not qualify if:

• multicentric or bilateral breast cancer
• mammography microcalcifications
• in situ breast carcinoma
• positive anamnesis for previous breast cancer
• positive anamnesis for medical or psychological conditions that prevent membership study

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Instituto of Oncology

Milan, Italy

Location

MeSH Terms

Conditions

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 28, 2020
• Study Start: June 1, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 28, 2023

Record last verified: 2023-06

Locations

IT (1)