Feasibility and Identification of Breast Cancer Patients for Potential Avoidance of Surgery

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Procedure: Ultrasound-Guided Biopsy

• Registration Number: NCT02455791
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

The goal of this clinical research study is to compare the use of an ultrasound-guided biopsy with what is found during surgery in finding evidence of the disease.

Detailed Description

If you agree to take part in this study, you will have an ultrasound-guided biopsy of the tumor site. To perform this biopsy, a needle is inserted into the affected area using an ultrasound to collect cells or tissue from a tumor mass. The doctor will use the ultrasound to guide the needle into the area. Two (2) types of samples will be collected: a fine needle aspirate (FNA) that collects cells and a core biopsy that collects a small piece of tissue. If the tumor is not seen well by the ultrasound, the study doctor may use a mammogram to perform the biopsy.

You will then have the same planned surgery and post-operative care that you would normally have. You will sign a separate consent for your surgery.

Your medical records may be reviewed and information recorded from your routine follow-up visits in order to follow your general health and the outcome of your surgery.

Length of Study Participation:

Your active participation in this study will be finished when you have had your surgery and completed your post-operative care.

This is an investigational study. It is investigational to compare the use of an ultrasound-guided biopsy with what is found during surgery in finding evidence of the disease.

Up to 40 participants will take part on this study. All will be enrolled at MD Anderson.

Study Timeline

• Study First Submitted: 2015-05-26
• Study First Submitted QC: 2015-05-26
• Study First Posted: 2015-05-28
• Study Start: 2015-06-24
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-30
• Last Update Posted: 2025-04-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 43

Inclusion Criteria

1. >/= 18 years old
2. Histologic diagnosis of triple negative or HER2 amplified breast cancer, clinical stage T1-4, N0-3, M0/1 receiving preoperative systemic therapy and planned surgery

Exclusion Criteria

1. N/A

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrasound-Guided Biopsy of Tumor Site	Ultrasound-Guided Biopsy	Ultrasound-guided biopsy of the tumor site performed before scheduled surgery.

Primary Outcome Measures

Name	Time	Method
Diagnostic Accuracy of Ultrasound-Guided FNA and Core Biopsy of Initial Breast Cancer Region Compared to Standard Surgery with Pathologic Evaluation	1 day	Accuracy of FNA and core biopsy determined by comparing these biopsy results to the pathologic evaluation removed during standard surgery. Estimates and 95% confidence intervals for accuracy, sensitivity, false negative rate (FNR), specificity as well as the negative predictive value (NPV) reported for FNA and core biopsy based on the exact Clopper-Pearson method.

Trial Locations

Locations (1)

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States