2.3. Treatment and Assessments
neurotoxicity, Cancer
ADVERSE EVENT, ADVERSE EVENT, CANCER
Eligible and consented patients were randomized 1:1 to either:Arm A: Weekly paclitaxel plus trastuzumab (P-H): Paclitaxel 80 mg/mArm B: 3-weekly docetaxel-cyclophosphamide plus trastuzumab (TC-H): Docetaxel 75 mg/mBoth regimens are provincially funded in Ontario, Canada and were given at standard approved doses and intervals. Assignment to the treatment groups was stratified by centre and neoadjuvant versus adjuvant treatment. Randomization used a permuted block design of 2 and 4. Allocation was performed either by the physician or by a research associate, using REDCap (Research Electronic Data Capture), a secure web-based software platform designed to support data collection developed by Vanderbilt University.As this was a pragmatic trial, follow-up visits occurred as per usual care with no study-mandated schedules. Endpoint data were collected from several sources, including case report forms and from the patient’s electronic health records. Patient-reported outcomes were completed with self-completed questionnaires. The Functional Assessment of Cancer Therapy–Taxane Score (FACT-Taxane) (43 questions including the 27-item FACT-G and an 11-item score from a neurotoxicity subscale within a 16-item taxane subscale) is a validated measure of health-related QOL of patients receiving taxane-containing chemotherapy [Adverse events were collected according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 [