- 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
- Trastuzumab Registration
- Trastuzumab in Combination with Chemotherapy
- Trastuzumab in Combination with Chemotherapy - Design - Stratification to Chemotherapy
- Trastuzumab in Combination with Chemotherapy - Enrollment
- Summary: Phase III Clinical Trial Comparing Best Available Chemotherapy to Same Therapy + Trastuzumab
- Trastuzumab in Combination with Chemotherapy - Survival Time
- Clinical Safety - Summary of Trastuzumab Safety
- Trastuzumab in Combination with Chemotherapy - Cardiac Dysfunction Outcomes (CREC)
- Conclusion
- Adjuvant use of Trastuzumab must be evaluated in a randomized-controlled trial
- BCIRG 006 Adjuvant Treatment of Breast Cancer Node Positive and High Risk Node Negative
- Protocol definition of “clinically significant cardiac events”
- Protocol stopping rule for excessive cardiac toxicity
- Protocol definition of “clinically significant asymptomatic LVEF decline”
- BCIRG 006 Study Status
- Overall Follow-up: Date of Randomization to Last Follow-up Evaluation
- Database Status
- Chemotherapy administration - cycles
- Chemotherapy administration
- Trastuzumab administration
- Potential cardiac risk factors
- Pre-existing cardiac signs and symptoms
- Discontinuation of Trastuzumab
- Clinically significant cardiac events
- LVEF Declines by NYHA Class
- Clinically significant cardiac events
- Compliance with repeat LVEF assessments
- Patients with >15% absolute LVEF decline and below LLN, using any assessment method
- Patients with >15% relative LVEF decline and below LLN, using same assessment method
- Conclusions - 1
- Conclusions - 2
- Conclusions - 3
- Conclusions - 4
- Conclusions - 5
- Acknowledgements
- Acknowledgements
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Dennis J Slamon, MD, PhD |