Percutaneous Biopsy After Neoadjuvant Chemotherapy. (VAC-Biopsy)
2026년 6월 8일 업데이트: Jose Roberto Morales Piato, Instituto do Cancer do Estado de São Paulo
Evaluation of the Accuracy of Vacuum-assisted Percutaneous Biopsy in Predicting Mammary Anatomopathological Response in Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy
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.
연구 개요
상태
아직 모집하지 않음
정황
상세 설명
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.
To evaluate the accuracy of VAB in predicting mammary anatomopathological response in breast cancer patients undergoing neoadjuvant chemotherapy.
This is a cross-sectional study conducted at the Cancer Institute of the State of São Paulo (ICESP). It will include patients with invasive mammary carcinoma cT1-T3, N0-N1, M0, of any immunohistochemical profile, with complete clinical and imaging response or residual lesion ≤ 2 cm after neoadjuvant chemotherapy. VAB will be guided by ultrasound or stereotaxy, with at least six fragments obtained and shaving of the remaining area. The concordance between VAB findings and surgical specimen will be analyzed by sensitivity, specificity, and accuracy.
연구 유형
중재적
등록 (추정된)
100
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: José RM Piato, MD, PhD
- 전화번호: 55 3893-2000
- 이메일: icesp.pesqclinica@hc.fm.usp.br
연구 장소
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São Paulo
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São Paulo, São Paulo, 브라질, 01246000
- Instituto do Câncer do Estado de São Paulo - ICESP
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Vacuum-Assisted Biopsy (VAB)
Vacuum-assisted percutaneous biopsy has the capacity to assess the response to neoadjuvant chemotherapy with satisfactory accuracy in relation to surgical resection
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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.
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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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
기간: From completion of neoadjuvant chemotherapy to definitive breast surgery
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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). |
From completion of neoadjuvant chemotherapy to definitive breast surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Rate of Complete Residual Lesion Removal by Vacuum-Assisted Biopsy (VAB) Confirmed by Surgical Specimen Histopathology
기간: From VAB procedure to surgical resection
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To evaluate the ability to completely remove residual lesions after chemotherapy in breast cancer using vacuum-assisted percutaneous biopsy. Complete residual lesion removal will be defined as the absence of residual invasive carcinoma or DCIS in the VAB specimens, confirmed by the absence of residual tumor in the surgical specimen. Results will be expressed as a proportion (%) of participants achieving complete lesion removal. |
From VAB procedure to surgical resection
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: José RM Piato, MD, PhD, Breast Surgeon at ICESP; Associate Professor at FMUSP.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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- Boman 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.
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 6월 1일
기본 완료 (추정된)
2026년 11월 1일
연구 완료 (추정된)
2026년 12월 1일
연구 등록 날짜
최초 제출
2026년 5월 26일
QC 기준을 충족하는 최초 제출
2026년 6월 8일
처음 게시됨 (실제)
2026년 6월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 8일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 5405/25
- 94924026.0.0000.0068 (기타 식별자: Brazilian Ethics Approval (Plataforma Brasil))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
It has been decided not to share individual participant data (IPD) related to the study for several reasons.
Protecting the privacy of participants is a priority.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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