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

European Institute of Oncology

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Procedure: vacuum-assisted breast biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT04365803

IEO 0758/

Details and patient eligibility

About

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.

Full 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

Enrollment: 22 estimated patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

22 participants in 1 patient group

patient with radiological complete response

Description:

patient with radiological complete response after neoadjuvant chemotherapy

Treatment:

Procedure: vacuum-assisted breast biopsy