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

  • STATUS
    Recruiting
  • days left to enroll
    26
  • participants needed
    650
  • sponsor
    City of Hope Medical Center
Updated on 18 July 2021
cancer

Summary

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.

Description

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.

Details
Condition Diet and Nutrition, Chronic Diarrhea, Skin Wounds, Chronic Shoulder Pain, Vaginal Atrophy, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, Anal Dysplasia, Primary Immunodeficiency, Pediatric Health, Near-Sighted Corrective Surgery, Peripheral Arterial Occlusive Disease, Brain Function, Healthy Subject, Recurrent Respiratory Papillomatosis, Razor Bumps (Pseudofolliculitis Barbae), Metastatic Triple-Negative Breast Cancer
Treatment laboratory biomarker analysis, magnetic resonance imaging, biospecimen collection, Biopsy of Breast
Clinical Study IdentifierNCT03303846
SponsorCity of Hope Medical Center
Last Modified on18 July 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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