Statement: Results from the primary trial and the secondary trial indicate Abraxane + Tigatuzumab produce better ORR than Caelyx, Docetaxe and Trastuzumab.
Primary_evidence: Outcome Measurement:    Number of Participants Who Had a Tumor Response, According to Standard RECIST (Response Evaluation Criteria in Solid Tumors) Criteria   Those who achieved either complete (disappearance of all target lesions) or partial (at least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD) response.   Time frame: Week 09, Week 18, at the end of each patient's treatment, and at 3, 6, 9, and 12 months after end of treatment. Results 1:    Arm/Group Title: Caelyx, Docetaxel, Trastuzumab   Arm/Group Description: Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx.   Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab.   Overall Number of Participants Analyzed: 26   Measure Type: Number   Unit of Measure: Participants  Participants who had a complete tumor response: 2   Participants who had a partial tumor response: 13   Participants who did not have a tumor response: 11
Secondary_evidence: Outcome Measurement:    Objective Response Rate   Patient response rates will be measured by the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI. Responses include the following: Complete Response (CR) disappearance of all target lesions; Partial Response (PR) at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) best response from the start of treatment until disease progression.   Time frame: Baseline to 6 months Results 1:    Arm/Group Title: Abraxane + Tigatuzumab   Arm/Group Description: Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients with disease progression will be taken off the study.   Overall Number of Participants Analyzed: 39   Measure Type: Number   Unit of Measure: percentage of patients  28        (14.9 to 45.0) Results 2:    Arm/Group Title: Abraxane Alone   Arm/Group Description: Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).   Overall Number of Participants Analyzed: 21   Measure Type: Number   Unit of Measure: percentage of patients  38        (18 to 61.1)