Over 200,000 women are diagnosed with breast cancer annually in the United States and breast cancer is responsible for approximately 45,000 deaths annually in the U.S. While those diagnosed with early-stage breast cancer have excellent outcomes, 10-20% of newly diagnosed breast cancer patients present with locally advanced breast cancer in which recurrence and death is significantly higher. The absolute number of these cancers has not decreased over time and successful treatment options remain limited. The ISPY-2 Trial was developed in partnership with the FDA to try to accelerate the development of novel agents. This study found early support from Gateway, and it led to the identification of several predictive biomarkers for specific agents including neratinib, veliparib, MK2206, pembrolizumab, and TDM-1. Predictive biomarkers identify patients most likely to benefit from a given treatment, sparing other patients from toxicities of ineffective treatments. Now, new targeted agents require exploration including ganetsipib, talazoparib, patritumab, and ganitumab. This study will identify predictive biomarkers for these agents. If the study is successful, it could lead to new and improved patient-specific treatments for breast cancer patients.
Trial Registration: ClinicalTrials.gov Identifier: NCT01042379