Materials and Methods
TTP, Cancer
TTP, CANCER
UPCI 99-058 was a phase II single-arm, open-label clinical trial of Taxotere (docetaxel) in combination to carboplatin and Herceptin (trastuzumab) in patients with HER2+ MBC. Forty patients were enrolled at the University of Pittsburgh Cancer Institute (UPCI). The study was conducted in accordance with the Declaration of Helsinki. Patients were provided with written informed consent prior to registering in the study.The primary objective was RR. Secondary objectives were response duration (RD), time to progression (TTP), OS, percent one-year survival, and safety. Definition of response objectives and inclusion/exclusion criteria can be found in the study protocol. The present study was initiated in 1999, and therefore, measurement of lesions following RECIST was not performed.Patient accrual followed a Simon 2-step study design. Kaplan-Meier methods were used to assess TTP and OS. Data cutoff for TTP and OS was February 18, 2020. Chi-squared tests with Yates’ correction were used to compare the distribution of clinically meaningful categorical variables. Statistical tests were performed 2-sided with an α of <0.05 to be considered statistically significant.The study protocol (IRB#0411034) was approved by the institutional review board (IRB) and conducted in accordance with the Declaration of Helsinki. Patients were provided with written informed consent prior to registering in the study.