Statement: the primary trial and the secondary trial investigate different outcome measures for different interventions.
Primary_evidence: Outcome Measurement:    Pharmacokinetics (PK) of Oral Itraconazole   To determine the pharmacokinetics (PK) of oral itraconazole in patients with MBC by measuring mean trough plasma levels at steady state at weeks 2 and 4.   Time frame: pre-dose at Weeks 2 and 4 Results 1:    Arm/Group Title: Itraconazole   Arm/Group Description: oral itraconazole 200mg a day until disease progression or unacceptable toxicities.   Overall Number of Participants Analyzed: 12   Mean (Standard Deviation)   Unit of Measure: ng/mL  Week 2 Intraconazole Concentration: 230.7         (216.8)   Week 4 Intraconazole Concentration: 305.8         (334.8)   Week 2 6-OH Itraconazole Concentration: 454.8         (429.3)   Week 4 6-OH Itraconazole Concentration: 501.6         (502.6)
Secondary_evidence: Outcome Measurement:    Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Paclitaxel Combination Via Reporting of Dose-limiting Toxicity (DLT)   To establish the safety of escalating doses of MM-121 in combination with paclitaxel in order to determine the recommended phase 2 dose. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD.   Time frame: From date of first dose to 30 days after termination, the longest 163 weeks Results 1:    Arm/Group Title: Part 1: Dose Escalation: Cohort 1   Arm/Group Description: MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV   Overall Number of Participants Analyzed: 7   Measure Type: Number   Unit of Measure: participants reporting DLTs  0 Results 2:    Arm/Group Title: Part 1: Dose Escalation: Cohort 2   Arm/Group Description: MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV   Paclitaxel - 80mg/m2 weekly IV   Overall Number of Participants Analyzed: 3   Measure Type: Number   Unit of Measure: participants reporting DLTs  1