Statement: At least 400 participants in the primary trial receiving an oral treatment of film-coated Afatinib tablet at a starting dose of 40 milligram (mg) once daily and weekly 10 minutes intravenous infusions of Vinorelbine 25 mg/meter^2 (meter=m) had a PFS over 9 months.
Primary_evidence: Outcome Measurement:    Progression-free Survival (PFS)   PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by investigator according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment.   Only data collected until the cut-off date for RECIST 1.1 based endpoints (08Jun2013) were considered.   Progression of disease was determined if at least 1 of the following criteria applied:   At least a 20% increase in the sum of the diameters (SoD) of target lesions taking as reference the smallest SoD recorded since the treatment started, together with an absolute increase in the SoD of at least 5 mm   Appearance of 1 or more new lesions   Unequivocal progression of existing non-target lesions   Time frame: From randomization (07Sep2010) until disease progression, death or data cut-off (08Jun2013); Up to 34 months Results 1:    Arm/Group Title: Afatinib + Vinorelbine (AV)   Arm/Group Description: Participants received oral treatment of film-coated Afatinib tablet at a starting dose of 40 milligram (mg) once daily and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/meter^2 (meter=m) on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days. For Afatinib, a protocol-defined dose-reduction scheme was to be followed if a participant experienced certain pre-specified adverse events. From 26 April 2013, any participant who had been randomised to the AV arm stopped treatment, had the option to switch to Trastuzamb + Vinorelbine.   Overall Number of Participants Analyzed: 339   Median (Inter-Quartile Range)   Unit of Measure: Months  5.49        (3.55 to 9.07) Results 2:    Arm/Group Title: Trastuzumab + Vinorelbine (TV)   Arm/Group Description: Participants received an intravenous infusion of Trastuzumab 2 mg/kilogram (kg) weekly, following an initial loading dose of 4 mg/kg and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/m^2 on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days.   Overall Number of Participants Analyzed: 169   Median (Inter-Quartile Range)   Unit of Measure: Months  5.55        (3.55 to 10.84)