Statement: 100% of participants in the Afatinib 30mg + Herceptin group of the primary trial suffer Dose Limiting Toxicities.
Primary_evidence: Outcome Measurement:    Number of Participants With Dose Limiting Toxicities (DLT)   Number of participants with DLT in the first cycle (28 days) for the determination of the maximum tolerated dose (MTD). Important Limitations and Caveats are provided in the respective section.   Time frame: 28 days Results 1:    Arm/Group Title: Afatinib 20mg + Herceptin   Arm/Group Description: Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit. This group includes patients from the dose-escalation cohort and from the expansion cohort.   Overall Number of Participants Analyzed: 13   Measure Type: Number   Unit of Measure: Participants  4 Results 2:    Arm/Group Title: Afatinib 30mg + Herceptin   Arm/Group Description: Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit.   Overall Number of Participants Analyzed: 2   Measure Type: Number   Unit of Measure: Participants  2