Percutaneous Biopsy After Neoadjuvant Chemotherapy.
Starting soon · Not applicable
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT07644455
- Run by
- Instituto do Cancer do Estado de São Paulo
- People needed
- 100
- Starts
- 2026-06-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-06-12
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Instituto do Câncer do Estado de São Paulo - ICESP — São Paulo, São Paulo, Brazil
Full record on ClinicalTrials.gov
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