AS709 - Validation of blood-based biomarkers for the early detection of ER+ breast cancer
Investigator Names and Contact Information
Christopher Li (cili@fredhutch.org)
Introduction/Intent
There is an urgent need for breast cancer early detection biomarkers given that none with clinical utility have yet been identified, and given the public health importance of breast cancer. Mammography is certainly a valuable tool; it reduces mortality by 30% among women 50-69 years of age (Fletcher 1993) and is widely used in many developed countries. However, mammography’s performance varies by some key factors. For example, while its positive predictive value (PPV) is 10% among women age 60 years, it is only 2% among women age 40 years. Breast cancer still remains the second leading cause of cancer mortality in women in the United States, and the leading cause of cancer mortality in women worldwide despite improvements in technology and the widespread use of mammography. There are several reasons for this including mammography’s sensitivity and specificity, access to screening services, and the variable utility of mammography to detect different types of tumors.
As described below, through funding from NCI’s Early Detection Research Network (EDRN) we have discovered and validated a number of novel blood-based biomarkers with potential clinical utility for the early detection of ER+ breast cancer. Pending further validation, we envision three near term potential clinical applications for these biomarkers: 1. Test for women 50-69 years of age who have a negative mammogram that informs timing of a subsequent mammogram (early recall in 6 months vs. next mammogram in 1 year); 2. Test to inform continuation of mammographic screening among women over 75 years of age (while USPTF does not recommend mammography for women ≥75 years of age, many women in this age range continue to get screened (Yao 2014); 3. Test to identify a high risk group of women 50-69 years of age without easy access to mammography or in areas with scarce mammography screening resources (rural areas/developing countries) who should be prioritized for screening. The performance of markers needed for them to be clinically meaningful is described in our approach.
The Specific Aims of this study are:
- Conduct a validation study of top ranked biomarkers individually in WHI CT samples to further define their performance and potential clinical utility for the early detection of ER+ breast cancer.
- Assess the performance of different combinations of markers to determine the panel with optimal performance.
