Clinical trial · Interventional
Percutaneous Biopsy After Neoadjuvant Chemotherapy.
Evaluation of the Accuracy of Vacuum-assisted Percutaneous Biopsy in Predicting Mammary Anatomopathological Response in Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy
NCT07644455CI-TRIAL-00114604VAC-Biopsynot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pre-Neoadjuvant Chemotherapy Clipping | Device | — | UNRESOLVED |
| Vacuum-Assisted Biopsy (VAB) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vacuum-Assisted Biopsy (VAB)
- description
- Vacuum-assisted percutaneous biopsy has the capacity to assess the response to neoadjuvant chemotherapy with satisfactory accuracy in relation to surgical resection
- interventionNames
- Device: Pre-Neoadjuvant Chemotherapy Clipping
- Procedure: Vacuum-Assisted Biopsy (VAB)
Primary outcomes (1)
- measure
- 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
- description
- To evaluate the accuracy of vacuum-assisted percutaneous biopsy in predicting mammary anatomopathological response in breastcancer patients undergoing neoadjuvant chemotherapy. The diagnostic accuracy of VAB will be assessed by calculating sensitivity, specificity, PPV, NPV, and overall accuracy using the surgical specimen histopathological analysis as the reference standard (gold standard).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (13)
- BACKGROUNDBoman C, Tranchell C, Liu X, Eriksson Bergman L, Toli MA, Bergh J, Foukakis T, Matikas A. Prognosis After Pathologic Complete Response to Neoadjuvant Therapy in Early-Stage Breast Cancer: A Population-Based Study. J Natl Compr Canc Netw. 2025 Mar 12;23(4):e247093. doi: 10.6004/jnccn.2024.7093. PMID 40073831
- BACKGROUNDHeil J, Pfob A, Sinn HP, Rauch G, Bach P, Thomas B, Schaefgen B, Kuemmel S, Reimer T, Hahn M, Thill M, Blohmer JU, Hackmann J, Malter W, Bekes I, Friedrichs K, Wojcinski S, Joos S, Paepke S, Ditsch N, Rody A, Grosse R, van Mackelenbergh M, Reinisch M, Karsten M, Golatta M; RESPONDER Investigators. Diagnosing Pathologic Complete Response in the Breast After Neoadjuvant Systemic Treatment of Breast Cancer Patients by Minimal Invasive Biopsy: Oral Presentation at the San Antonio Breast Cancer Symposium on Friday, December 13, 2019, Program Number GS5-03. Ann Surg. 2022 Mar 1;275(3):576-581. doi: 10.1097/SLA.0000000000004246. PMID 32657944
- BACKGROUNDPinder SE, Shaaban A, Deb R, Desai A, Gandhi A, Lee AHS, Pain S, Wilkinson L, Sharma N. NHS Breast Screening multidisciplinary working group guidelines for the diagnosis and management of breast lesions of uncertain malignant potential on core biopsy (B3 lesions). Clin Radiol. 2018 Aug;73(8):682-692. doi: 10.1016/j.crad.2018.04.004. PMID 29773220
- BACKGROUNDModestino F, Cappelli A, Mosconi C, Peta G, Bruno A, Vara G, De Benedictis C, Golfieri R. Balloon-assisted coil embolization (BACE) of a wide-necked aneurysm of the inferior pancreaticoduodenal artery. CVIR Endovasc. 2020 Sep 5;3(1):62. doi: 10.1186/s42155-020-00155-w. PMID 32889684
- BACKGROUNDJin J. Counseling on Healthy Diet and Physical Activity to Prevent Cardiovascular Disease. JAMA. 2020 Nov 24;324(20):2114. doi: 10.1001/jama.2020.22344. No abstract available. PMID 33231666
- BACKGROUNDRached FH, Rocha VZ, Santos RD, Serrano CV, Caixeta A. Computed tomography angiography defined vulnerable plaque in a patient with low high-density lipoprotein cholesterol and subsequent myocardial infarction. Coron Artery Dis. 2017 Dec;28(8):712-714. doi: 10.1097/MCA.0000000000000524. No abstract available.