Percutaneous Biopsy After Neoadjuvant Chemotherapy.
100 patients around the world
Available in Brazil
Neoadjuvant chemotherapy is widely used in the treatment of locally advanced breast
cancer or in early stages of triple-negative or HER2 overexpressing tumors. Pathological
complete response (pCR) to neoadjuvant chemotherapy is associated with better clinical
outcomes. However, confirmation of pCR still depends on surgery, which may represent
overtreatment for some patients. In this context, image-guided vacuum-assisted
percutaneous biopsy (VAB) has been investigated as an alternative to assess tumor
response and potentially avoid breast surgery in the future. However, there are no
studies evaluating this strategy in brazilian patients, the majority of whom present with
locally advanced tumors at diagnosis.
To evaluate the accuracy of VAB in predicting mammary anatomopathological response in
breast cancer patients undergoing neoadjuvant chemotherapy.
This is a cross-sectional study conducted at the Cancer Institute of the State of São
Paulo (ICESP). It will include patients with invasive mammary carcinoma cT1-T3, N0-N1,
M0, of any immunohistochemical profile, with complete clinical and imaging response or
residual lesion ≤ 2 cm after neoadjuvant chemotherapy. VAB will be guided by ultrasound
or stereotaxy, with at least six fragments obtained and shaving of the remaining area.
The concordance between VAB findings and surgical specimen will be analyzed by
sensitivity, specificity, and accuracy.
Instituto do Cancer do Estado de São Paulo
1Research sites
100Patients around the world
This study is for people with
Breast Cancer
Requirements for the patient
From 18 Years
Female
Medical requirements
Female patients with invasive non-special type mammary carcinoma (any immunohistochemical subtype: luminal, triple-negative, or HER2+).
Indication for neoadjuvant chemotherapy.
Tumor clipping performed prior to neoadjuvant chemotherapy.
Clinical staging cT1-T3, N0-N1, M0, defined by clinical examination, mammography, breast MRI, chest/abdomen/pelvis CT, and bone scintigraphy.
Complete clinical and imaging response OR residual lesion ≤2 cm in largest diameter on mammography and MRI after neoadjuvant chemotherapy and before surgical treatment.
Multicentric tumors (> 2 lesions).
Current use of anticoagulants.
Extensive calcifications (> 2 cm).
Pregnant women.
Not undergoing surgical treatment.
Personal history of other malignancies in the last 5 years.
Absence of residual lesion on imaging in cases of clip migration from the tumor bed marking.
Sites
Instituto do Câncer do Estado de São Paulo "Octavio Frias de Oliveira" - ICESP
Av. Dr. Arnaldo, 251 - Consolação, São Paulo - SP, 01255-090, Brazil