Percutaneous Biopsy After Neoadjuvant Chemotherapy. (NCT07644455) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Percutaneous Biopsy After Neoadjuvant Chemotherapy.
Brazil100 participantsStarted 2026-06
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing whether a vacuum-assisted biopsy after chemotherapy can accurately detect if the cancer is completely gone — could this approach potentially replace or delay surgery for me, and what would it mean if the biopsy result turned out to be wrong in either direction?
2Since this trial is 'not yet recruiting,' do you know when it's expected to open, and would it make sense for me to consider standard surgical options now rather than waiting?
3The trial is measuring how reliably the vacuum-assisted biopsy matches what's found in the actual surgical specimen — does that mean all participants still undergo surgery regardless of biopsy results, and if so, how does that affect the risks or burden for me?
4This trial doesn't have a numbered phase, which suggests it may be a diagnostic accuracy study rather than a treatment trial — can you help me understand what I would actually gain or risk by participating compared to just following my standard treatment plan?
5If my tumor responds well to neoadjuvant chemotherapy, how would knowing my likelihood of pathological complete response change my treatment decisions, and is this kind of biopsy testing already available to me outside of a trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sensitivity, Specificity, Positive Predictive Value (PPV), and Negative Predictive Value (NPV) of Vacuum-Assisted Biopsy (VAB) in Detecting Pathological Complete Response (pCR) Compared to Surgical Specimen Histopathology
Timeframe: From completion of neoadjuvant chemotherapy to definitive breast surgery