Statement: the primary trial and the secondary trial measure the DLT of their respective interventions, using the same time frame.
Primary_evidence: Outcome Measurement:    Dose Limiting Toxicity Incidence of Neratinib in Combination With Paclitaxel   Dose Limiting Toxicity in subjects with solid tumors treated with neratinib, administered daily, in combination with paclitaxel 80 mg/m² IV on days 1, 8, and 15 of a 28 day cycle.   Time frame: From first dose date through day 28 Results 1:    Arm/Group Title: Neratinib 160 mg + Paclitaxel 80 mg/m    Arm/Group Description: Neratinib 160 mg qd + Paclitaxel 80 mg/m  IV on days 1, 8, and 15 of a 28 day cycle.   Overall Number of Participants Analyzed: 3   Measure Type: Count of Participants   Unit of Measure: Participants  0   0.0% Results 2:    Arm/Group Title: Neratinib 240 mg + Paclitaxel 80 mg/m    Arm/Group Description: Neratinib 240 mg qd + Paclitaxel 80 mg/m  IV on days 1, 8, and 15 of a 28 day cycle.   Overall Number of Participants Analyzed: 5   Measure Type: Count of Participants   Unit of Measure: Participants  0   0.0%
Secondary_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