Statement: over 20% of patients in the primary trial and the secondary trial Experienced myocardial infarction or arrhythmia, with the majority of those coming from the secondary trial.
Primary_evidence: Outcome Measurement:    Number of Participants Who Experienced Cardiac Events (Level 1 or 2), or Inability to Administer Trastuzumab Either During the 8 Cycles of Chemotherapy or According to Package Insert for a Total Duration of 1 Year   Cardiac events defined as:   Level 1: Cardiac death due to heart failure (HF), myocardial infarction or arrhythmia, or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event, or severe symptomatic HF, concomitant with a left ventricular ejection fraction (LVEF) drop of >10 percentage points from baseline and to 50% LVEF   Level 2: Asymptomatic systolic dysfunction or mildly symptomatic HF concomitant with an LVEF drop of >10 percentage points from baseline and to <50% LVEF; the LVEF drop was to have been confirmed within 3-4 weeks.   Time frame: 8 cycles of chemotherapy and subsequently one year of planned trastuzumab treatment Results 1:    Arm/Group Title: Pegylated Liposomal Doxorubicin (PLD) Based Regimen   Arm/Group Description: PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)   Overall Number of Participants Analyzed: 120   Measure Type: Number   Unit of Measure: Participants  5 Results 2:    Arm/Group Title: Doxorubicin Based Regimen   Arm/Group Description: doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)   Overall Number of Participants Analyzed: 59   Measure Type: Number   Unit of Measure: Participants  11
Secondary_evidence: Outcome Measurement:    Time to Progression (TTP) - Expert Evaluation Committee Assessment   Time in months from randomization to first documentation of objective tumor progression or death due to breast cancer, whichever comes first. Tumor progression was determined by the expert evaluation committee using RECIST version 1.0 as an at least a 20% increase in the sum of the longest diameters (SLD) of the target lesions compared to the smallest SLD since the study treatment started. For participants with bone metastasis only, at least 25% increase in the measurable lesion according to General Rules for Clinical and Pathological Study of Breast Cancer (The 14th edition).   Time frame: Up to 2008 days of the treatment Results 1:    Arm/Group Title: Exemestane   Arm/Group Description: One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.   Overall Number of Participants Analyzed: 147   Median (95% Confidence Interval)   Unit of Measure: months  13.8        (10.8 to 16.5) Results 2:    Arm/Group Title: Anastrozole   Arm/Group Description: One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.   Overall Number of Participants Analyzed: 145   Median (95% Confidence Interval)   Unit of Measure: months  11.1        (10.8 to 16.6)