BCIRG006-ArandomizedPhaseIIITrialComparing.pptVIP

SlamonDennis_v2fr 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 Initial efficacy from 1st planned analysis as of 6/30/05 (to be presented at SABCS-12/05) and Summary of cardiac data as of 4th Planned Analysis - 3222 patients from 12/31/04 Trastuzumab Registration9/26/98 Trastuzumab in Combination with Chemotherapy Primary Time to disease progression (REC) Safety Secondary Overall response rates Durations of response Time to treatment failure 1-year survival Quality of life Trastuzumab in Combination with Chemotherapy No prior anthracyclines Trastuzumab in Combination with Chemotherapy Total enrolled 469 Summary: Phase III Clinical Trial Comparing Best Available Chemotherapy to Same Therapy + Trastuzumab Enrolled Trastuzumab in Combination with Chemotherapy Overall Trastuzumab impact on survival uncertain Limited duration of follow-up (?12 months) CT alone patients allowed to enter Trastuzumab extension protocol Preliminary analysis - improved 1-yr survival H + CT = 78% alive CT alone = 67% alive Clinical Safety Trastuzumab is generally well tolerated Single agent Combined with chemotherapy Most adverse events mild to moderate in severity Infusion associated symptoms, including fever and chills primarily with first dose Serious adverse events infrequent Increased incidence of cardiac dysfunction, particularly when administered with anthracycline based therapy Trastuzumab in Combination with Chemotherapy Conclusion The results of this study indicate that Trastuzumab in combination with chemotherapy is well-tolerated and provides substantial clinical benefit in first-line treatment of HER-2 overexpressing metastatic breast cancer Future studies of Trastuzumab will be important Adjuvant breast cancer Other combinations Other tumors Adjuvant use of Trastuzumab must be evaluated in a randomized-controlled trial Protocol definition of “clinically significant cardiac