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Clinical Perspective Where Biomarkers Can Make a Difference Decision to Intervene: normal Evidence of Disease Disability Death Opportunity #1: Fate Regression, Stability, Progression Opportunity #2: Rate Slow, Moderate, Fast Opportunity #3: intervention/reverse fate Targeted to biologic subtype Screening/Prevention Who is at risk for what type Treatment What type and when Risk Assessment Problems/opportunities Tumor heterogeneity Along a spectrum of indolent to aggressive From early to late risk for recurrence Among patients with high risk for early recurrence Within a given tumor For those at risk, standard therapy has made a difference, but not all benefit equally or at all There are hundreds of agents in the pipeline but limited ability to test them Biomarkers/ Companion Diagnostics for targeted agents are lacking Women at Risk for Early Systemic Recurrence of Breast Cancer Biomarker: 70 gene high risk Are unlikely to be cured with surgery alone Order of surgery, systemic therapy has no impact on survival outcomes Neoadjuvant approach is an opportunity Downstage tumors, refine local therapy options Better understand response to therapy, prognosis Accelerate targeted drug development to improve outcomes in highest risk women Particularly relevant as a tool to sort out optimal treatments in the molecular era Feedback to consortium Analysis of biomarker data Drug graduates Agreement on candidate marker MARKER PHASE Promising qualifying biomarker Acceleration of Knowledge Turns File IDE Identify next agent combination 3 YR RFS confirms SCREENING pCR result PHASE CONFIRMATORY ContinuousAdapts on drugs enrollment PHASE (~60 patients) Enroll, on biomarker randomize Adapts pCR (~300 patients) I-SPY 2 TRIAL on amendment signal approved qualifying confirmed biomarkers or is dropped Surgical Therapy to Confirm pCR Agent Enters New agent/combination qualifies and is approved for I-SPY 2 pCR not confirmed Full Approval Accelerated Approval for Agent/ Approval for biomarker/PMA