2.4. Objectives and Endpoints
≥50%.The, HER2-positive
SECONDARY, RECRUITMENT
The overall aim of the study was to assess the feasibility of conducting a pragmatic clinical trial using an Integrated Consent Model in a population of patients with HER2-positive EBC. If proven feasible, then a future large-scale clinical trial could be conducted comparing the potential efficacy of weekly P-H (paclitaxel plus trastuzumab) versus TC-H (docetaxel plus cyclophosphamide plus trastuzumab) in this patient population. We also wanted to preliminarily explore clinical safety and quality of life outcomes as secondary objectives.Primary objective: To determine the feasibility of conducting a pragmatic clinical trial using an Integrated Consent Model with a combination of feasibility endpoints. The rates for each of these feasibility endpoints were established by discussion with study investigators before the study started and confirmed in the statistical analysis plan (SAP) (10 June 2020). For the study to be deemed feasible overall, the study must meet or exceed all of these criteria. These feasibility endpoints included:The patient acceptability rate reflects the percentage of approached patients who were enrolled in the trial. To be deemed feasible this number must be ≥75%.The active participation rate of medical oncologists is defined as the percentage of medical oncologists who approached patients for the study. To be deemed feasible, this number must be ≥50%.The treatment receipt rate represents the percentage of enrolled patients who received their chemotherapy within the trial. To be deemed feasible, this number must be ≥90%.The treatment completion rate is characterized by the percentage of expected chemotherapy cycles completed with no dose modifications (reductions, delays, or discontinuations). To be deemed feasible, this number must be ≥75%.The recruitment rate is defined as the number of patients accrued to the study, divided by the duration of recruitment. To be deemed feasible, this number should be ≥2 patients/month.The questionnaire completion rate represents the percentage of expected questionnaires that were completed per patient with no missing responses. To be deemed feasible, the questionnaire completion rate must be ≥80%.