Statement: the primary trial and the secondary trial monitor the %  of their patient cohorts with DFS < 6years.
Primary_evidence: Outcome Measurement:    Disease-free Survival (DFS)   Disease-free survival (DFS) for all patients regardless of randomization will be determined by patients' own physicians at the individual study sites during routine follow-up screening. This will occur every three months for the first 24 months after completion of primary therapies and every six months thereafter with clinical exam, and laboratory and radiographic surveillance. The primary objective of the study is disease-free survival (DFS) at 24 months.   Time frame: Disease-free survival at 24 months Results 1:    Arm/Group Title: Herceptin + NeuVax Vaccine   Arm/Group Description: Patients randomized to this arm will receive Herceptin every 3 weeks as monotherapy for 1 year; the first Herceptin infusion will be given no sooner than 3 weeks and no later than 12 weeks after completion of standard of care chemotherapy/radiotherapy. Herceptin will be dosed at the recommended initial loading dose of 8 mg/kg and at recommended maintenance doses of 6 mg/kg q3wk. Patients will receive vaccinations of NeuVax vaccine administered intradermally every 3 weeks for 6 total vaccinations, 30-120 minutes after completion of Herceptin infusion. The NeuVax vaccine series will begin immediately after completion of the third Herceptin infusion, but may be delayed to the fourth or fifth Herceptin infusion with prior approval from the PI. After completion of primary vaccine series, patients will receive NeuVax vaccine booster inoculations to be administered every 6 months x 4 for total treatment duration of 30 months.   Overall Number of Participants Analyzed: 136   Measure Type: Number   Unit of Measure: Percentage of participants who survived  89.8 Results 2:    Arm/Group Title: Herceptin + GM-CSF Only   Arm/Group Description: Patients randomized to this arm will receive Herceptin every 3 weeks as monotherapy for 1 year. The first Herceptin infusion will be given no sooner than 3 weeks and no later than 12 weeks after completion of standard of care chemotherapy/radiotherapy. Herceptin will be dosed at the recommended initial loading dose of 8 mg/kg and at recommended maintenance doses of 6 mg/kg q3wk. Patients will receive inoculations of GM-CSF only (250mcg) administered intradermally every 3 weeks for 6 total inoculations, 30-120 minutes after completion of Herceptin infusion. The GM-CSF only inoculation series will begin immediately after completion of the third Herceptin infusion. After completion of six-inoculation primary vaccine series, patients will then receive a total of four GM-CSF only booster inoculations to be administered at 12, 18, 24, and 30 months from the date of the first Herceptin infusion.   Overall Number of Participants Analyzed: 139   Measure Type: Number   Unit of Measure: Percentage of participants who survived  83.8
Secondary_evidence: Outcome Measurement:    Percentage of Participants With Disease Free Survival at 5 Years   Disease Free Survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method.   Time frame: From randomization until relapse or death or up to 5 years Results 1:    Arm/Group Title: Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)   Arm/Group Description: Doxorubicin 60 mg/m  IV bolus injection in combination with cyclophosphamide 600 mg/m  IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m  IV infusion every 3 weeks for another 4 cycles.   Overall Number of Participants Analyzed: 1073   Measure Type: Number   Unit of Measure: percentage of participants  75.5        (72.8 to 78.2) Results 2:    Arm/Group Title: AC Followed by Docetaxel + Herceptin (AC→TH)   Arm/Group Description: Doxorubicin 60 mg/m  IV bolus injection in combination with cyclophosphamide 600 mg/m  IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m  IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.   Overall Number of Participants Analyzed: 1074   Measure Type: Number   Unit of Measure: percentage of participants  83.2        (80.9 to 85.4)