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.
EDRN Renewal flyer NOTE-New receipt deadline for applications submitted for all EDRN FOAs is January 20, 2015, by 5:00 PM local time of applicant organization.
There will be a Pre-Application webinar to discuss each of the four individual EDRN FOAs on Tuesday, December 2nd, 2014, from 1pm-5pm (Eastern). Potential applicants interested in participating in the webinar should send a message to Dr. Sharmistha Ghosh (firstname.lastname@example.org) no later than 5:00 p.m. (EST) November 21, 2014. Please mention the FOA of interest in the subject line.
EDRN Patient Advocates will host an EDRN Advocacy Educational Webinar, Biomarkers for Prostate Cancer Detection and Monitoring, on Monday, January 12th, 2015, at 1 p.m. EDT / 10 a.m. PDT. Registration is not required for this. Please click for more information.