Percutaneous Biopsy After Neoadjuvant Chemotherapy.

NCT07644455 | Not Yet Recruiting

• 2 other identifiers: 5405/2594924026.0.0000.0068
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Breast cancer; Neoadjuvant chemotherapy; Percutaneous biopsy; Vacuum-assisted biopsy; Pathological complete response; Conservative surgery

Outcome Measures

Primary Outcomes (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

  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 Outcomes (1)

• Rate of Complete Residual Lesion Removal by Vacuum-Assisted Biopsy (VAB) Confirmed by Surgical Specimen Histopathology

  From VAB procedure to surgical resection

Study Arms (1)

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

Device: Pre-Neoadjuvant Chemotherapy Clipping; Procedure: Vacuum-Assisted Biopsy (VAB)

Interventions

Vacuum-Assisted Biopsy (VAB) 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.

Vacuum-Assisted Biopsy (VAB)

Pre-Neoadjuvant Chemotherapy Clipping DEVICE

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.

Vacuum-Assisted Biopsy (VAB)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Study Sites (1)

Instituto do Câncer do Estado de São Paulo - ICESP

São Paulo, São Paulo, 01246000, Brazil

Location

Related Publications (13)

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  PMID: 32101663 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• José RM Piato, MD, PhD

  Breast Surgeon at ICESP; Associate Professor at FMUSP.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

José RM Piato, MD, PhD

CONTACT

55 3893-2000; icesp.pesqclinica@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Cross-sectional, single-center study, conducted at the Cancer Institute of the State of São Paulo (ICESP).

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 12, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)