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

Trial Status: Active

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.

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

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE
Contact: Tanya Chavez
Phone: 626-218-0634
Los Angeles
USC / Norris Comprehensive Cancer Center
Status: ACTIVE
Contact: Kristy Watkins
Phone: 323-865-0452

North Carolina

Durham
Duke University Medical Center
Status: ACTIVE
Contact: Jennifer Gallagher
Phone: 919-970-1551

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE
Contact: Sarah Woelke
Phone: 419-308-4708

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: ACTIVE
Contact: Renae M. Quale
Phone: 608-263-7898

PRIMARY OBJECTIVE:

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

SECONDARY OBJECTIVE:

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 OBJECTIVE:

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 also undergo collection of breast tissue samples at any breast biopsy or breast surgery.

Trial Phase Phase NA

Trial Type Screening

Lead Organization
City of Hope Comprehensive Cancer Center

Principal Investigator
Victoria Louise Seewaldt

  • Primary ID 17009
  • Secondary IDs NCI-2017-01757
  • Clinicaltrials.gov ID NCT03303846