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Biomarkers in Clinical Perspective: Enhancing Breast Cancer Treatment Outcomes

Learn how biomarkers shape treatment decisions for breast cancer, from risk assessment to targeted therapy selection, in the quest for improved outcomes and personalized care. Explore the challenges and opportunities in precision medicine.

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Biomarkers in Clinical Perspective: Enhancing Breast Cancer Treatment Outcomes

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  1. Clinical Perspective

  2. Where Biomarkers Can Make a Difference normal Evidence of Disease Disability Death Screening/Prevention Who is at risk for what type Decision to Intervene: Risk Assessment Treatment What type and when

  3. 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

  4. 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

  5. Acceleration ofKnowledge Turns MARKER PHASE Full Approval SCREENING PHASE Adapts on drugs (~60 patients) CONFIRMATORY PHASE Adapts on biomarker (~300 patients) Accelerated Approval for Agent/ Approval for biomarker/PMA pCR not confirmed Agent Enters New agent/combination qualifies and is approved for I-SPY 2

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