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

Comparison Between Histological VABB and Histological Post-surgery in Patient With Complete Pathological Response After Neoadjuvant Systemic Treatment: Pilot Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: vacuum-assisted breast biopsy

Detailed Description

The study articulates in five phases:

Phase one: acquisition of the informed consent followed by positioning a clip into the cancer bed (by radiologist) if not already present; Phase two: after radiological confirmation of pathological Complete Response (pCR) done performing breast ultrasound, MRI and 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose positron emission tomography (18-FDG-PET) after neoadjuvant chemotherapy the patient becomes candidate to VABB pre surgery.

Phase three: the patient has VABB within 15 day from the term of neoadjuvant chemotherapy Phase four: definitive surgical intervention within 30 days from the end of the neoadjuvant chemotherapy Phase five: verification of correspondence between histology of VABB and definitive histology.

The study hypothesis is that VABB could be used in the patients with pCR to the imaging post-neoadjuvant chemotherapy to confirm sensibility and specificity of 18 FDG TC PET and breast MRI to show the absence of breast cancer.

The use of VABB with negative histology result could bring to a therapeutic gold standard without over surgical treatment

• Study Type: Observational
• Enrollment (Estimated): 22

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy
    • European Instituto of Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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;
• M0
• cancer bed identified pre neoadjuvant chemotherapy by clip

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patient with radiological complete response; patient with radiological complete response after neoadjuvant chemotherapy	Procedure: vacuum-assisted breast biopsy; patient with radiological complete response after neoadjuvant chemotherapy undergo to vacuum assisted breast biopsy and the to definitive surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Principal Investigator: Elisabetta Rossi, MD, European Institute of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 27, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: breast cancer; vacuum assisted breast biopsy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IEO 0758/

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No