[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642735":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":31,"locations":36,"responsibleParty":49,"collaborators":21,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":21,"enrollmentInfo":62,"targetDuration":21,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":78,"whyStopped":21,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Instituto do Cancer do Estado de São Paulo","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Vacuum-Assisted Biopsy (VAB)","EXPERIMENTAL","Vacuum-assisted percutaneous biopsy has the capacity to assess the response to neoadjuvant chemotherapy with satisfactory accuracy in relation to surgical resection",[13,14],"Device: Pre-Neoadjuvant Chemotherapy Clipping","Procedure: Vacuum-Assisted Biopsy (VAB)",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DEVICE","Pre-Neoadjuvant Chemotherapy Clipping","Patients with an indication for neoadjuvant chemotherapy will be referred for clipping the lesion diagnosed with breast cancer in order to allow subsequent localization of its topography in cases of good response or complete response to treatment. This procedure will be guided by ultrasound, and a specific material consisting of a cannula containing a clip inside is used. Through ultrasound, the cannula is inserted into the center of the target lesion and the clip is positioned at this topography. To allow the clip to be located by ultrasound, it must have a shape that minimizes migration after being positioned, as well as characteristics and dimensions that make it visible on ultrasound, as this method will be preferred for performing the biopsy of the lesion region after neoadjuvant chemotherapy.",[9],null,{"type":23,"name":9,"description":24,"armGroupLabels":25,"otherNames":21},"PROCEDURE","Patients with no residual lesion or residual lesion ≤2 cm on MRI and mammography will undergo vacuum-assisted biopsy (VAB) targeting the primary lesion, using the pre-placed clip as a reference under ultrasound or stereotactic guidance. Initially, 6-12 tissue samples will be obtained (7-10G needle) from the clip region, with specimen radiography performed to confirm clip retrieval; additional sampling will continue if the clip is not identified. This initial sample (AM1) will be formalin-fixed. A second set of 6-12 samples will then be collected from the margins of the biopsy cavity (\"shaving\") and fixed separately (AM2). Following sampling, a new clip will be placed at the biopsy site, and mammographic imaging will confirm its position. The final clip will guide subsequent surgical resection.",[9],[27],{"name":28,"affiliation":29,"role":30},"José RM Piato, MD, PhD","Breast Surgeon at ICESP; Associate Professor at FMUSP.","PRINCIPAL_INVESTIGATOR",[32],{"name":28,"role":33,"phone":34,"phoneExt":21,"email":35},"CONTACT","55 3893-2000","icesp.pesqclinica@hc.fm.usp.br",[37],{"facility":38,"status":21,"city":39,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":21},"Instituto do Câncer do Estado de São Paulo - ICESP","São Paulo","01246000","Brazil","BR",{"type":44,"coordinates":45},"Point",[46,47],-46.63611,-23.5475,{"lat":47,"lon":46},{"type":30,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"Jose Roberto Morales Piato","MD, PhD","100642735","percutaneous-biopsy-after-neoadjuvant-chemotherapy-100642735",false,"NCT07644455","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","VAC-Biopsy","Inclusion Criteria:\n\n* Female patients with invasive non-special type mammary carcinoma (any immunohistochemical subtype: luminal, triple-negative, or HER2+)\n* Indication for neoadjuvant chemotherapy\n* Tumor clipping performed prior to neoadjuvant chemotherapy\n* Clinical staging cT1-T3, N0-N1, M0, defined by clinical examination, mammography, breast MRI, chest\u002Fabdomen\u002Fpelvis CT, and bone scintigraphy\n* Complete clinical and imaging response OR residual lesion ≤2 cm in largest diameter on mammography and MRI after neoadjuvant chemotherapy and before surgical treatment\n\nExclusion Criteria:\n\n* Multicentric tumors (\\> 2 lesions)\n* Current use of anticoagulants\n* Extensive calcifications (\\> 2 cm)\n* Pregnant women\n* Not undergoing surgical treatment\n* Personal history of other malignancies in the last 5 years\n* Absence of residual lesion on imaging in cases of clip migration from the tumor bed marking","FEMALE","18 Years",{"count":63,"type":64},100,"ESTIMATED","INTERVENTIONAL",[67],"NA","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.",[70],"Breast Cancer",[72,73,74,75,76,77],"Breast cancer","Neoadjuvant chemotherapy","Percutaneous biopsy","Vacuum-assisted biopsy","Pathological complete response","Conservative surgery","NOT_YET_RECRUITING","2026-06-08",{"date":81,"type":82},"2026-06-12","ACTUAL",{"date":84,"type":64},"2026-06",{"date":86,"type":64},"2026-12",{"name":5,"class":6},1]