Statement: participants from both cohorts of the primary trial had a drastically lower CNS Objective Response Rate than those in the secondary trial.
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)