Statement: Most the primary trial participants suffered Grade 3 or above Cardiotoxicity Events After Cycle 8 of the study.
Primary_evidence: Outcome Measurement:    Grades of Cardiotoxicity Events in the Subset of Patients Reporting a Cardiotoxicity Event   This table summarizes the cardiotoxicity events of different grades. Grade 1 is a decline of left ventricular ejection fraction(LVEF) >=10% but <20% of baseline value. Grade 2 is LVEF below LLN (50%) or decline of LVEF >=20% of baseline value. Grade 3 is congestive heart failure responsive to treatment. Please note that only a subset of patients reported cardiotoxic events so the totals will not add up to the total number of participants.   Time frame: Baseline, after cycle 4 (~84 days), after cycle 8 (~168 days), and 30 or more days after last cycle of induction therapy Results 1:    Arm/Group Title: Arm I: Doxorubicin and Taxotere   Arm/Group Description: Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.   Overall Number of Participants Analyzed: 16   Measure Type: Number   Unit of Measure: participants  Grade 1 After Cycle 4 (approx. 84 days): 2   Grade 1 After Cycle 8 (approx. 168 days): 4   Grade 1 After 30 days or more after last cycle: 1   Grade 2 After Cycle 4 (approx 84 days): 3   Grade 2 After Cycle 8 (approx 168 days): 4   Grade 2 After 30 days or more after last cycle: 1   Grade 3 After Cycle 4 (approx 84 days): 1   Grade 3 After Cycle 8 (approx 168 days): 0   Grade 3 After 30 days or more after last cycle: 0 Results 2:    Arm/Group Title: Arm II: Doxorubicin, Taxotere, and Herceptin   Arm/Group Description: Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.   Overall Number of Participants Analyzed: 37   Measure Type: Number   Unit of Measure: participants  Grade 1 After Cycle 4 (approx. 84 days): 12   Grade 1 After Cycle 8 (approx. 168 days): 8   Grade 1 After 30 days or more after last cycle: 10   Grade 2 After Cycle 4 (approx 84 days): 0   Grade 2 After Cycle 8 (approx 168 days): 2   Grade 2 After 30 days or more after last cycle: 5   Grade 3 After Cycle 4 (approx 84 days): 0   Grade 3 After Cycle 8 (approx 168 days): 0   Grade 3 After 30 days or more after last cycle: 0