Early diagnosis of triple negative breast cancer would likely have significant impact on overall breast cancer mortality. This proposal is designed to systematically evaluate and compare multiple blood-based biomarkers for triple negative breast cancer. This is a team effort among multiple EDRN members, BDLs, and CEVCs.
The overall study design involves the identification of three distinct types of blood-based biomarkers:
1. Autoantibodies (Anderson/LaBaer) 2. Protein antigens (Li/Lampe; Zangar). 3. miRNA
(Huebner/Croce). These biomarkers will be validated in a step-wise fashion using samples provided by the CEVCs and multi-institutional cohorts, with study design and evaluation by the DMCC.
Aim 1. Verification of novel biomarkers for TNBC
Aim 2. Validate the top biomarkers for TNBC using a diagnostic set of plasma.
Aim 3. Determine the sensitivity, specificity, and positive predictive value of the top marker
combinations found in aim 2 to distinguish TNBC from benign breast disease, and for the detection of ER+ and Her2+ breast cancer, using the EDRN Reference Set.
Aim 4. Develop a phase III validation plan for testing the top biomarkers and biomarker combination for TNBC detection using prediagnostic sera from WHI, ROCA, and PLCO.
We will systematically compare existing TNBC biomarkers that have been identified from multiple laboratories, targeting protein antigens, autoantibodies, and miRNAs. These biomarkers will be validated in a step-wise fashion using samples provided by the CEVCs and multi institutional cohorts, with study design and evaluation by the DMCC. The individual and composite sensitivities and specificities of these biomarkers for the detection of TNBC and non-TNBC breast cancers will be evaluated. These studies will lead to the development of a phase III validation plan for testing the top biomarkers and biomarker combination for TNBC detection using prediagnostic sera from WHI, ROCA, and PLCO.
Thank you to everyone who helped make the 27th EDRN Steering Committee Meeting a success. We look forward to seeing everyone at the 9th EDRN Scientific Workshop from September 8-11, 2014 in Washington D.C.