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

NCT ID: NCT04365803

Last Updated: 2023-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2023-12-31

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.

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

Conditions

Breast Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

patient with radiological complete response

patient with radiological complete response after neoadjuvant chemotherapy

vacuum-assisted breast biopsy

Intervention Type: PROCEDURE

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

Interventions

vacuum-assisted breast biopsy

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

European Institute of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elisabetta Rossi, MD

Role: PRINCIPAL_INVESTIGATOR

European Institute of Oncology

Locations

European Instituto of Oncology

Milan, , Italy

Countries

Italy

Other Identifiers

IEO 0758/

Identifier Type: -

Identifier Source: org_study_id