Percutaneous Biopsy After Neoadjuvant Chemotherapy.
ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorInstituto do Cancer do Estado de São Paulo
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Multicentric tumors (> 2 lesions)
Current use of anticoagulants
Extensive calcifications (> 2 cm)
Pregnant women
Trial design
Treatments tested in this trial
- Pre-Neoadjuvant Chemotherapy Clipping
- Vacuum-Assisted Biopsy (VAB)
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov