Breast Cancer
Research volume 25,
Article number: 20 (2023)
Background
Mammography screening has been proven to detect breast
cancer at an early stage and reduce mortality; however, it has low accuracy in
young women or women with dense breasts. Blood-based diagnostic tools may
overcome the limitations of mammography. This study assessed the diagnostic
performance of a three-protein signature in patients with suspicious breast
lesions.
Findings
This trial (MAST; KCT0004847) was a prospective multicenter
observational trial. Three-protein signature values were obtained using serum
and plasma from women with suspicious lesions for breast malignancy before
tumor biopsy. Additionally, blood samples from women who underwent clear or
benign mammography were collected for the assays. Among 642 participants, the
sensitivity, specificity, and overall accuracy values of the three-protein
signature were 74.4%, 66.9%, and 70.6%, respectively, and the concordance index
was 0.698 (95% CI 0.656, 0.739). The diagnostic performance was not affected by
the demographic features, clinicopathologic characteristics, and co-morbidities
of the participants.
Conclusions
The present trial showed an accuracy of 70.6% for the
three-protein signature. Considering the value of blood-based biomarkers for
the early detection of breast malignancies, further evaluation of this
proteomic assay is warranted in larger, population-level trials.
This Multi-protein Assessment using Serum to deTermine
breast lesion malignancy (MAST) was registered at the Clinical Research
Information Service of Korea with the identification number of KCT0004847 (https://cris.nih.go.kr).
