Outcomes
tumor, death, cancers, congenital anomaly/birth defect, BOR, disability/incapacity, Cancer
DISEASE PROGRESSION, TUMOR, ADVERSE EVENT, CANCERS, ADVERSE EVENT, EVENT, CANCER
The primary efficacy objective was to evaluate the best overall response (BOR), with tumor responders defined as individuals with confirmed complete response (CR) or partial response (PR), as determined by the study investigator using RECIST 1.1. Secondary efficacy endpoints included PFS (time from the first day of study treatment until first documented disease progression, as determined by the investigator using RECIST 1.1, or death due to any cause, whichever occurred first) and OS (time from the first day of study treatment until death due to any cause). Adverse events (AEs), which were recorded throughout the study, were coded to the Medical Dictionary for Regulatory Activities (version 21.0) and graded per National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.03). A serious AE was defined as any AE that was fatal or life‐threatening, required or prolonged hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug, or was a significant medical event (per investigator's opinion). The primary pharmacokinetic objective was to quantify serum/plasma concentrations of T‐DM1 to determine exposure. Additional details regarding assessments are available in the Data To explore the relationship between biomarkers and tumor response and to evaluate biomarkers that could increase our understanding of the underlying biology of these cancers, the following exploratory biomarker analyses were undertaken: determination of HER2 protein expression pattern in correlation to 