BCIRG006 Phase III Trial
   
  1. BCIRG006 - Randomized Phase III Trial Comparing AC-T vs AC-TH vs TCH in HER2 Positive Node Positive or High Risk Node Negative Breast Cancer
  2. Trastuzumab Registration
  3. Trastuzumab in Combination with Chemotherapy
  4. Trastuzumab in Combination with Chemotherapy - Design - Stratification to Chemotherapy
  5. Trastuzumab in Combination with Chemotherapy - Enrollment
  6. Summary: Phase III Clinical Trial Comparing Best Available Chemotherapy to Same Therapy + Trastuzumab
  7. Trastuzumab in Combination with Chemotherapy - Survival Time
  8. Clinical Safety - Summary of Trastuzumab Safety
  9. Trastuzumab in Combination with Chemotherapy - Cardiac Dysfunction Outcomes (CREC)
  10. Conclusion
  11. Adjuvant use of Trastuzumab must be evaluated in a randomized-controlled trial
  12. BCIRG 006 Adjuvant Treatment of Breast Cancer Node Positive and High Risk Node Negative
  13. Protocol definition of “clinically significant cardiac events”
  14. Protocol stopping rule for excessive cardiac toxicity
  15. Protocol definition of “clinically significant asymptomatic LVEF decline”
  16. BCIRG 006 Study Status
  17. Overall Follow-up: Date of Randomization to Last Follow-up Evaluation
  18. Database Status
  19. Chemotherapy administration - cycles
  20. Chemotherapy administration
  21. Trastuzumab administration
  22. Potential cardiac risk factors
  23. Pre-existing cardiac signs and symptoms
  24. Discontinuation of Trastuzumab
  25. Clinically significant cardiac events
  26. LVEF Declines by NYHA Class
  27. Clinically significant cardiac events
  28. Compliance with repeat LVEF assessments
  29. Patients with >15% absolute LVEF decline and below LLN, using any assessment method
  30. Patients with >15% relative LVEF decline and below LLN, using same assessment method
  31. Conclusions - 1
  32. Conclusions - 2
  33. Conclusions - 3
  34. Conclusions - 4
  35. Conclusions - 5
  36. Acknowledgements
  37. Acknowledgements

Dennis J Slamon, MD, PhD