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



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/12/2019
Start Date:June 2015
End Date:June 2019

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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

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.

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.

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
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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from
Houston, TX
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