Development Of A Blood Test To Improve The Performance Of Breast Cancer Screening

Study Overview
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Brief Summary
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The purpose of this study is to collect blood and tissue to help develop tests that might be able to detect cancer earlier. The investigator will be collecting these samples and reviewing test results from participants who have had an area of concern found on breast imaging, as well as from participants who are scheduled to have a routine breast cancer screening mammogram.

Official Title
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MSK Discovery Study: Use of cfNA To Distinguish Between Benign and Malignant BI-RADS 4 Radiographic Lesions

Conditions
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Breast Cancer, Breast Benign

Intervention / Treatment
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* Device: Breast MRI
* Device: Breast Mammogram
* Other: Blood draw
* Procedure: Breast Biopsy
* Behavioral: online participant reported questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females with one or more BI-RADS 4 radiographic lesions who are undergoing ultrasound, stereotactic or MRI-guided breast biopsy at MSKCC or at an MSK Alliance Member Site. If multiple imaging modalities were employed (mammogram, ultrasound, MRI) and no integrated score is provided, then the highest BI-RADS score will be used. Age ≥ 18 years at the time of breast biopsy Willing to provide blood samples for research purposes before biopsy. Able to provide written informed consent Exclusion Criteria: Women with a BI-RADS 4 lesion who had the lesion previously biopsied Females with a current active malignancy other than non-melanoma skin cancers. Females are considered not to have a current active malignancy if they have completed therapy and have no evidence of systemic disease for at least three years from the initial diagnosis Currently pregnant women History of bilateral mastectomy. Participant has or is currently participating in another GRAIL-sponsored protocol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| normal mammograms (BI-RADS 1 or 2)<br> | Device: Breast MRI<br>* Participants with dense breast tissue will get a mammogram and MRI<br>Device: Breast Mammogram<br>* State-of-the-art full-field digital mammography (FFDM) and or digital breast tomosynthesis (DBT) comprising both raw and post-processed images as well as ultrasound and MRI images from the initial screening study will be collected and sent to the MSKCC Breast Radiology Department.<br>Other: Blood draw<br>* Participants will donate approximately 60ml of peripheral blood. Mononuclear cells from peripheral blood will be used to extract germline DNA. Germline genomic testing will be employed as a matched control for tumor sequencing and for germline breast cancer susceptibility testing.<br>Behavioral: online participant reported questionnaire<br>* Participants will be asked to complete a questionnaire that covers the topics of breast health, general health and lifestyle, genetic testing, personal, and family history of cancer.<br>|
| suspicious lesion group (BI-RADS 4)<br> | Device: Breast MRI<br>* Participants with dense breast tissue will get a mammogram and MRI<br>Device: Breast Mammogram<br>* State-of-the-art full-field digital mammography (FFDM) and or digital breast tomosynthesis (DBT) comprising both raw and post-processed images as well as ultrasound and MRI images from the initial screening study will be collected and sent to the MSKCC Breast Radiology Department.<br>Other: Blood draw<br>* Participants will donate approximately 60ml of peripheral blood. Mononuclear cells from peripheral blood will be used to extract germline DNA. Germline genomic testing will be employed as a matched control for tumor sequencing and for germline breast cancer susceptibility testing.<br>Procedure: Breast Biopsy<br>* Tissue specimens from the biopsy of the BI-RADS 4 mammographic lesion and (among women undergoing surgical excision) the surgical specimen(s) will be subjected to genomic profiling at GRAIL, Inc. or MSKCC. The tumor specimens from the participants diagnosed with cancer during the follow-up period will also undergo molecular profiling.<br>Behavioral: online participant reported questionnaire<br>* Participants will be asked to complete a questionnaire that covers the topics of breast health, general health and lifestyle, genetic testing, personal, and family history of cancer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with malignant biopsy | result of the biopsy of the BIRADS 4 breast | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast imaging, 17-598