title: Crucial considerations for pipelines to validate circulating biomarkers for breast cancer.
abstract: Despite decades of progress in breast imaging, breast cancer remains the second most common cause of cancer mortality in women. The rapidly proliferative breast cancers that are associated with high relapse rates and mortality frequently present in younger women, in unscreened individuals, or in the intervals between screening mammography. Biomarkers exist for monitoring metastatic disease, such as CEA, CA27.29 and CA15-3, but there are no circulating biomarkers clinically available for early detection, prognosis, or monitoring for clinical relapse. There has been significant progress in the discovery of potential circulating biomarkers, including proteins, autoantibodies, nucleic acids, exosomes, and circulating tumor cells, but the vast majority of these biomarkers have not progressed beyond initial research discovery, and none have yet been approved for clinical use in early stage disease. Here, the authors review the crucial considerations of developing pipelines for the rapid evaluation of circulating biomarkers for breast cancer.
authors.affiliation: a Center for Personalized Diagnostics, Biodesign Institute , Arizona State University , Tempe , AZ , USA.
authors.forename: Radwa
authors.initials: R
authors.lastname: Ewaisha
authors.affiliation: b Department of Medical Oncology , Mayo Clinic Arizona , Scottsdale , AZ , USA.
authors.forename: Chelsea D
authors.initials: CD
authors.lastname: Gawryletz
authors.affiliation: a Center for Personalized Diagnostics, Biodesign Institute , Arizona State University , Tempe , AZ , USA.|b Department of Medical Oncology , Mayo Clinic Arizona , Scottsdale , AZ , USA.
authors.forename: Karen S
authors.initials: KS
authors.lastname: Anderson
mesh_terms: D014408:Biomarkers, Tumor / Q000097:blood*; D001943:Breast Neoplasms / Q000097:blood*; D005260:Female; D006801:Humans
chemical_list: D014408:Biomarkers, Tumor
keywords: Biomarker discovery; PRoBE principles; autoantibodies; breast cancer; early detection; pipeline; validation