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

Breast Cancer Clinical Trial

— BETTY  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04365803
• Other study ID #: IEO 0758/
• Status: Active, not recruiting
• Start date: June 1, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2023
• Source: European Institute of Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Italy	European Instituto of Oncology	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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