A Validation Study to Determine Concordance of Liquid Biopsy and Breast Cancer Diagnosis

Inclusion Criteria:

• • Women

• Age ≥ 18 years.

• Screening Mammography Cohort: Patients who were referred for screeningmammography and had mammography performed within 6 months prior to blood drawor will be undergoing mammography within 6 months after blood draw. Patientmust not have personal history of breast cancer, history of breast biopsy orprior abnormal mammography findings are allowed. OR

• Abnormal Screening Cohort: Patient who has had mammography that revealedabnormal results (BIRADS 3, 4, 5) or abnormal MRI results requiring furthertesting (additional imaging modality or biopsy). Patients must not have ahistory of breast cancer, history of breast biopsy, or prior abnormalmammography findings are allowed. The blood draw must occur in the time betweenthe abnormal mammography and start of definitive treatment (surgery orneoadjuvant chemotherapy). Patients who have already undergonesurgery/excisional biopsy due to abnormal mammography findings are noteligible. OR

• New Beast Cancer Cohort: Patients with new biopsy proven diagnosis of breastcancer (invasive breast cancer or DCIS) within 60 days of blood draw who hasnot started any cancer directed therapy, including surgery, radiation, hormonaltherapy or chemotherapy. Any breast cancer type patients at any stage areeligible. OR

• Remission Breast Cancer Cohort: Patients with personal history of localizedbreast cancer (stage 1, 2, 3) that has been previously treated with cancerdirected therapy, such as surgery, chemotherapy, radiation and/or hormonaltherapy who has been in completed remission. Patients must complete theirsurgery, adjuvant chemotherapy and/or radiation therapy prior to enrollment.The blood draw must occur at least 90 days after completion of the specifiedtreatment modalities. Patients on adjuvant hormonal therapy are eligible toenroll (those who are treated with adjuvant hormonal therapy in combinationwith CDK4/6 inhibitor must complete CDK4/6 inhibitor therapy prior toenrollment).

Exclusion Criteria:

• • Patients unable to give informed consent

• Patients who have received blood transfusion with 14 days prior to study blooddraw

• Patients who had a heart attack, stroke, or pulmonary embolism within 3 monthsto study blood draw

• Excisional breast biopsy in the prior 30 days. Needle biopsy of the breast ispermitted