Percutaneous Biopsy After Neoadjuvant Chemotherapy. (VAC-Biopsy)

June 8, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil, 01246000
        • Instituto do Câncer do Estado de São Paulo - ICESP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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.
Procedure: Vacuum-Assisted Biopsy (VAB)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: From completion of neoadjuvant chemotherapy to definitive breast surgery

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Complete Residual Lesion Removal by Vacuum-Assisted Biopsy (VAB) Confirmed by Surgical Specimen Histopathology
Time Frame: From VAB procedure to surgical resection

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto do Cancer do Estado de São Paulo

Investigators

  • Principal Investigator: José RM Piato, MD, PhD, Breast Surgeon at ICESP; Associate Professor at FMUSP.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 26, 2026

First Submitted That Met QC Criteria

June 8, 2026

First Posted (Actual)

June 12, 2026

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5405/25
  • 94924026.0.0000.0068 (Other Identifier: Brazilian Ethics Approval (Plataforma Brasil))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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