Statement: the primary trial studies the interventions impact on target lesions and the secondary trial measures changes in Bone Mineral Density, the results from these two studies are therefore not directly comparable.
Primary_evidence: Outcome Measurement:    Overall Response Rate   Overall Response Rate (ORR), subjects with CR or PR by independent review in subjects with ErbB-2-positive breast cancer treated at the MTD of neratinib in combination with vinorelbine per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.   Time frame: From first dose date to progression or last tumor assessment, up to four years and six months. Results 1:    Arm/Group Title: Neratinb 240 mg + Vinorelbine 25 mg/m  - No Prior Lapatinib   Arm/Group Description: Neratinib 240 mg qd + Vinorelbine 25 mg/m  IV on days 1 and 8 every 3 weeks, with no prior lapatinib exposure   Overall Number of Participants Analyzed: 64   Measure Type: Number   Unit of Measure: percentage of participants  35.9        (24.3 to 48.9) Results 2:    Arm/Group Title: Neratinib 240 mg + Vinorelbine 25 mg/m  - Prior Lapatinib   Arm/Group Description: Neratinib 240 mg qd + Vinorelbine 25 mg/m  IV on days 1 and 8 every 3 weeks, with prior Lapatinib exposure   Overall Number of Participants Analyzed: 15   Measure Type: Number   Unit of Measure: percentage of participants  13.3        (1.7 to 40.5)
Secondary_evidence: Outcome Measurement:    Percent Change From Baseline of Bone Mineral Density of the Lumbar Spine (L2-l4)   Lumbar spine (L2-L4) BMD measurements by dual energy X-ray absorptiometry (DXA) were performed after surgery and within 2 weeks prior to randomization and repeated every 6 months for the first 2 years and annually thereafter until 5 years after enrollment. The primary scanning site was the lumbar spine (L2 to L4) and the secondary scanning site was the total hip. All DXA scans were evaluated by a central reader.   Time frame: Baseline, 24 months Results 1:    Arm/Group Title: Letrozole   Arm/Group Description: 2.5 mg once daily (q.d.)orally for 5 years   Overall Number of Participants Analyzed: 63   Median (Full Range)   Unit of Measure: Percent Change  -4.63        (-14.21 to 4.32) Results 2:    Arm/Group Title: Tam-Let   Arm/Group Description: 20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.   Overall Number of Participants Analyzed: 68   Median (Full Range)   Unit of Measure: Percent Change  0.37        (-6.98 to 15.21)