Combined Breast MRI and Biomarker Strategies in Identifying High-risk Breast Cancer Patients (NCT03303846) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Combined Breast MRI and Biomarker Strategies in Identifying High-risk Breast Cancer Patients
United States344 participantsStarted 2017-10-13
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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
What they're measuring
1
Incidence of triple-negative breast cancer (invasive and/or ductal carcinoma in situ [DCIS]) within the 12-month period of the study