Vacuum Assisted Biopsy and Surgery Correlation in HER2 and TN Breast Cancer Subtypes MRI Responders After Neoadjuvant Therapy: BISUCO TRIAL

NCT06371989 | Completed

• 1 other identifier: 19/160
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND AND CURRENT STATUS: Advancements in neoadjuvant systemic treatments (NST) for HER2 positive and triple-negative (TN) breast cancer (BC) subtypes have led to high rates of pathologic complete response (pCR), raising questions about the necessity of subsequent surgery, especially for those undergoing adjuvant radiotherapy. While Magnetic Resonance Imaging (MRI) remains the most effective imaging technique for assessing neoadjuvant treatment response, surgery is still required to confirm pCR in cases of almost complete or complete MRI response (iCR). To safely avoid surgery in these BC "exceptional responders," a technique with high negative predictive value is imperative. OBJECTIVE: This study aims to establish the diagnostic efficacy of image-guided vacuum-assisted biopsy (VAB) in assessing pathological complete response (pCR) after NST in HER2 positive or TN breast cancer subtypes, particularly those showing post NST-MRI complete or almost complete response. METHODS: A prospective study was conducted at "Hospital Universitario 12 de Octubre de Madrid" from June 25, 2018, to October 25, 2029. Twenty-five patients with HER2-positive or TN operable invasive ductal carcinoma (IDC) BC subtype, at stages cT1-3/N0-2 undergoing primary NST and showing complete or almost complete response on post NST-MRI, were enrolled. Ultrasound or stereotactic-guided vacuum-assisted biopsy (VAB) of the previous clip and tumor bed area was performed before surgery. VAB pathological results were compared with surgical pathological results to evaluate the diagnostic efficacy of predicting pCR with VAB after NST. Pathological representativeness of the VAB sample was ensured. pCR was defined as the absence of invasive ductal carcinoma and in situ ductal carcinoma.

Conditions

Breast Cancer; Breast Biopsy

Keywords

Neoadjuvant response; Vacuum assisted biopsy

Outcome Measures

Primary Outcomes (1)

• The negative Predictive Value (NPV), Positive predictive value, specificity and sensibility of the VAB compared to Standard Surgery with Pathologic Evaluation

  Ultrasound or stereotactic-guided vacuum-assisted biopsy (VAB) of the previous clip and tumor bed area was performed before surgery. VAB pathological results were compared with surgical pathological results to evaluate the NPV, PPV , specificity and sensibility of predicting pCR with VAB after NST

  15 days

Study Arms (1)

Image-Guided Vacuum assisted biopsy of Tumor Site

EXPERIMENTAL

Image-guided biopsy of the tumor bed and coil area performed before surgery

Procedure: Image guided vacuum assisted biopsy

Interventions

Image guided vacuum assisted biopsy PROCEDURE

Image guided VAB of tumor site. A needle is inserted into the affected tumor bed area using an US or stereotactic method to collect cells or tissue from a tumor mass.

Image-Guided Vacuum assisted biopsy of Tumor Site

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years
• Biopsy-proven operable breast IDC non-otherwise specified (no other subtypes) with or without DCIS
• HER2-positive (score 3+ in immunohistochemistry or HER2 amplification in FISH) or TN subtypes as per immunohistochemistry
• Stages cT1-2/N0-2/M0
• Administration of standard complete neoadjuvant systemic treatment
• Complete or almost complete response on breast post NST-MRI

You may not qualify if:

• Uncompleted NST or non-operable breast carcinoma
• Associated suspicious microcalcifications on diagnostic mammogram measuring more than 20mm
• Proven multicentric or multifocal disease
• High-risk patients
• Personal history of breast cancer (ipsilateral or contralateral)

Sponsors & Collaborators

• Hospital Universitario 12 de Octubre: lead

Study Sites (1)

Sara Jimenez Arranz

Madrid, 28020, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• sara jimenez arranz

  Hospital Universitario 12 de Octubre Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 17, 2024
• Study Start: March 11, 2019
• Primary Completion: March 20, 2021
• Study Completion: December 20, 2022
• Last Updated: April 17, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 6 months

Locations

ES (1)