Combined Breast MRI and Biomarker Strategies in Identifying High-risk Breast Cancer Patients



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:1/31/2019
Start Date:October 13, 2017
End Date:October 2021

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Combined Breast MRI/Biomarker Strategies to Identify Aggressive Biology

This clinical trial studies normal breast tissue changes combined with breast magnetic
resonance imaging (MRI) that may suggest the beginnings of cancer development. Using breast
tissue markers in combination with breast imaging such as MRI may help to more accurately
assess a woman's risk of developing breast cancer.

PRIMARY OBJECTIVES:

I. To determine the number of high risk women with abnormal screening breast MRI and
morphologically normal biopsy over 7 years.

SECONDARY OBJECTIVES:

I. To determine if WNT10B/mutant p53 expression as measured in the 0-month biopsy predicts
women with an abnormal MRI/non-cancerous biopsy who will progress to cancer over 7 years.

TERTIARY OBJECTIVES:

I. To determine the predictive accuracy of WNT10B with MRI, of which will be compared with
MRI alone using the C-index.

OUTLINE:

Participants undergo standard of care high risk breast cancer screening MRIs at baseline and
follow-up and blood sample collection at baseline. Participants undergo collection of breast
tissue samples at any breast biopsy or breast surgery.

Inclusion Criteria:

- Women who are undergoing screening breast MRI as per standard of care for high-risk
breast cancer screening

- Willing to donate left-over tissue if patient undergoes a breast biopsy and/or breast
surgery

- Willing to have about 40 mL of blood (approximately 3 tablespoons) drawn

- Documented informed consent of the participant

Exclusion Criteria:

- Allergy or intolerance to gadolinium

- Inability to undergo breast MRI (e.g. claustrophobia)

- Participants with active cancer diagnosis (exception: skin cancer, biopsy-proven
atypical lobular, ductal hyperplasia and/or lobular carcinoma in situ)

- Previous diagnosis of stage 4 cancer

- Participants who have received cytotoxic chemotherapy within 1 year prior to screening
breast MRI

- Participants who have received endocrine therapy within 1 year prior to screening
breast MRI

- Participants who have received breast radiation within 1 year prior to screening
breast MRI

- Radiation to both breasts

- Pregnant and/or lactating within 1 year prior to screening breast MRI

- Receives screening breast MRIs at an outside facility other than the consenting
institution
We found this trial at
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1145 Olentangy River Road
Columbus, Ohio 43212
Principal Investigator: Steven K. Clinton, MD
Phone: 419-308-4708
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Terry Hyslop, PhD
Phone: 919-970-1551
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Los Angeles, California 90033
213) 740-2311
Principal Investigator: Julie E. Lang, MD
Phone: 323-865-0452
University of Southern California The University of Southern California is one of the world’s leading...
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Duarte, California 91010
Principal Investigator: Victoria Seewaldt, MD
Phone: 626-218-0634
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Duarte, CA
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Madison, Wisconsin 53792
(608) 263-2400
Principal Investigator: Ruth O'Regan, MD
Phone: 608-263-7898
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Madison, WI
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