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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02455791
Recruitment Status : Active, not recruiting
First Posted : May 28, 2015
Last Update Posted : March 11, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Ultrasound-Guided Biopsy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : June 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ultrasound-Guided Biopsy of Tumor Site
Ultrasound-guided biopsy of the tumor site performed before scheduled surgery.
Procedure: Ultrasound-Guided Biopsy
Ultrasound-guided biopsy of tumor site. A needle is inserted into the affected area using an ultrasound to collect cells or tissue from a tumor mass. Two (2) types of samples collected.




Primary Outcome Measures :
  1. 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 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02455791


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Henry Kuerer, MD, PHD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02455791    
Other Study ID Numbers: 2014-1039
NCI-2015-01221 ( Registry Identifier: NCI CTRP )
First Posted: May 28, 2015    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020
Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Triple negative breast cancer
HER2 amplified breast cancer
Ultrasound-guided biopsy
Fine needle aspirate
FNA
Core biopsy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases