Statement: The Median length of time that a patient in Arm A of the primary trial survived after receiving a TNBC diagnosis was 6 months.
Primary_evidence: Outcome Measurement:    Progression-free Survival (PFS)   Analysis of the primary endpoint, PFS, will be performed using Cox regression with treatment group as a single covariate.   Time frame: From randomization to the earliest date of documentation of disease progression, up to 5 years Results 1:    Arm/Group Title: Arm A   Arm/Group Description: Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO   Overall Number of Participants Analyzed: 19   Median (95% Confidence Interval)   Unit of Measure: Median survival and CI in months  6.0        (4.3 to 8.6) Results 2:    Arm/Group Title: Arm B   Arm/Group Description: Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1  hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO   Overall Number of Participants Analyzed: 37   Median (95% Confidence Interval)   Unit of Measure: Median survival and CI in months  4.9        (2.9 to 8.5)