Statement: In both the secondary trial and the primary trial the test cohorts produced better results than the control groups.
Primary_evidence: Outcome Measurement:    Progression-free Survival (PFS)   PFS was defined as the interval from study entry until disease progression or death resulting from any cause, which ever occurred first. Progression is defined as a 20% increase in the sum of longest diameter of target lesions (per RECIST criteria).   Time frame: Interval from randomization until disease progression or death, whichever occurs first, assessed up to 5 years Results 1:    Arm/Group Title: Arm I (Lapatinib)   Arm/Group Description: Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.   Overall Number of Participants Analyzed: 146   Median (95% Confidence Interval)   Unit of Measure: months  4.7        (3.7 to 5.7) Results 2:    Arm/Group Title: Arm II (Placebo)   Arm/Group Description: Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.   Overall Number of Participants Analyzed: 145   Median (95% Confidence Interval)   Unit of Measure: months  3.8        (3.8 to 5.6)
Secondary_evidence: Outcome Measurement:    Number of Participants With Overall Response (OR), Defined as Those Participants Achieving Complete Response (CR) or Partial Response (PR), Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 and Cutaneous Lesions   RECIST-based response assessment was done at Weeks (Wks) 4 and 8 and every 8 weeks thereafter. Cutaneous disease assessment was done at Wk 4 and every 4 weeks thereafter. OR was evaluated when the skin and RECIST assessments coincided. Per RECIST, CR is the disappearance of all target and non-target lesions; PR is at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD. Cutaneous disease contained non-measurable and measurable skin disease, which was assessed by skin assessment tools.   Time frame: Baseline until disease progression/recurrence was documented, assessed for up to 66 weeks Results 1:    Arm/Group Title: Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo   Arm/Group Description: Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).   Overall Number of Participants Analyzed: 38   Measure Type: Number   Unit of Measure: participants  11 Results 2:    Arm/Group Title: Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg   Arm/Group Description: Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.   Overall Number of Participants Analyzed: 38   Measure Type: Number   Unit of Measure: participants  17