Statement: the primary trial studies changes in tumour diameter, whereas the secondary trial investigates changes in heart failure rate.
Primary_evidence: Outcome Measurement:    Primary Endpoint : Compare Best Overall Response Rate (ORR) (According to Response Evaluation Criteria in Solid Tumor [RECIST] 1.1 Criteria) at Week 24 of MYL-1401O Plus Taxane Versus Herceptin® Plus Taxane in the ITT1 Population   Tumor measurements were perform by centralized blinded reviewers using RECIST 1.1 criteria. Per RECIST 1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm.Partial Response (PR): >/= 30% decrease sum of the diameters of target lesions from baseline sum diameters.   Progressive Disease (PD): </= 20% increase in the sum of the diameters of target lesions, from the smallest sum on study with at least a 5 mm absolute increase in the sum of all lesions. The appearance of one or more new lesions* denotes disease progression.   Stable Disease (SD): Neither sufficient decrease or increase. Evaluation of Non-Target Lesions Complete Response (CR): Disappearance of all non-target lesions. Non-complete Response/Non-Progressive Disease: Persistence of one or more non-target lesions. Progressive Disease (PD): Substantial, unequivocal progression of existing non-target lesions.   Time frame: from time of First treatment to week 24 Results 1:    Arm/Group Title: Herceptin  + Taxane   Arm/Group Description: Part 1: Herceptin  (trastuzumab) intravenously+ paclitaxel 80 mg/m2 weekly intravenously or docetaxel 75 mg/m2 intravenously once every three weeks (investigators choice) for 8 cycles then evaluate for primary endpoint.   Part 2: If SD or PR, CR at cycle 9 (week 24) proceed to Herceptin  (trastuzumab) alone once every 3 weeks until DP or subject withdrawal .   Overall Number of Participants Analyzed: 228   Measure Type: Count of Participants   Unit of Measure: Participants  Complete Response: 0   0.0%   Partial Response: 146  64.0%   Stable Disease: 49  21.5%   Progressive Disease: 20   8.8%   Not Evaluable: 13   5.7% Results 2:    Arm/Group Title: MYL-1401O Trastuzumab + Taxane   Arm/Group Description: Part 1:Myl 1401OTrastuzumab Intravenously + paclitaxel 80 mg/m2 weekly intravenously or docetaxel 75 mg/m2 intravenously once every three weeks (investigators choice) for 8 cycles then evaluate for primary endpoint.   Part 2: If SD or PR, CR at cycle 9 (week 24) proceed to Myl 1401O( Mylan Trastuzumab) alone once every 3 weeks until DP or subject withdrawal.   Overall Number of Participants Analyzed: 230   Measure Type: Count of Participants   Unit of Measure: Participants  Complete Response: 3   1.3%   Partial Response: 157  68.3%   Stable Disease: 48  20.9%   Progressive Disease: 9   3.9%   Not Evaluable: 13   5.7%
Secondary_evidence: Outcome Measurement:    Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12   Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.   Time frame: 12 months Results 1:    Arm/Group Title: Denosumab 60 mg Q6M   Arm/Group Description: [Not Specified]   Overall Number of Participants Analyzed: 123   Least Squares Mean (95% Confidence Interval)   Unit of Measure: Percent Change from Baseline  4.8        (4.3 to 5.4) Results 2:    Arm/Group Title: Placebo   Arm/Group Description: [Not Specified]   Overall Number of Participants Analyzed: 122   Least Squares Mean (95% Confidence Interval)   Unit of Measure: Percent Change from Baseline  -.7        (-1.3 to -.1)