Clinical trial NCT04365803: Histology VABB-Histology Post Surgery Pilot Project (BETTY Trial)
Official title: Comparison Between Histological VABB and Histological Post-surgery in Patient With Complete Pathological Response After Neoadjuvant Systemic Treatment: Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: breast cancer
vacuum assisted breast biopsy
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with triple negative or HER2 over-expressed breast cancer with radiological complete response after neoadjuvant chemotherapy

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

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

Primary outcomes:
measure: Evaluation of the accuracy of histological examination of the VABB performed pre-surgery
timeFrame: 45 days
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Instituto of Oncology
Study officials:
affiliation: European Institute of Oncology
name: Elisabetta Rossi, MD
role: PRINCIPAL_INVESTIGATOR
References: