Clinical Trials /

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

NCT02455791

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Feasibility and Identification of Breast Cancer Patients for Potential Avoidance of Surgery
  • Official Title: Pilot Study for Identification of Breast Cancer Patients for Potential Avoidance of Surgery: Accuracy of Image Guided Percutaneous Sampling Compared With Surgery to Evaluate Eradication of Breast Cancer After Preoperative Chemotherapy

Clinical Trial IDs

  • ORG STUDY ID: 2014-1039
  • SECONDARY ID: NCI-2015-01221
  • NCT ID: NCT02455791

Conditions

  • Breast Cancer

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Ultrasound-Guided Biopsy of Tumor SiteExperimentalUltrasound-guided biopsy of the tumor site performed before scheduled surgery.

    Eligibility Criteria

            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
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Diagnostic Accuracy of Ultrasound-Guided FNA and Core Biopsy of Initial Breast Cancer Region Compared to Standard Surgery with Pathologic Evaluation
    Time Frame:1 day
    Safety Issue:
    Description: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.

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Active, not recruiting
    Lead Sponsor:M.D. Anderson Cancer Center

    Trial Keywords

    • Breast Cancer
    • Triple negative breast cancer
    • HER2 amplified breast cancer
    • Ultrasound-guided biopsy
    • Fine needle aspirate
    • FNA
    • Core biopsy

    Last Updated

    January 5, 2018