Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
European Institute of Oncology
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
Age
18–99
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Histology VABB-Histology Post Surgery Pilot Project (BETTY Trial)
