1. Introduction
toxicity, Febrile neutropenia, HER2-positive, breast cancer
MAY, FEBRILE NEUTROPENIA, BREAST CANCER
Background: Neither paclitaxel plus trastuzumab (P-H) nor docetaxel-cyclophosphamide plus trastuzumab (TC-H) have been prospectively compared in HER2-positive early-stage breast cancer (EBC). A randomized trial was performed to assess the feasibility of a larger study. Methods: Lower-risk HER2-positive EBC patients were randomized to either P-H or TC-H treatment arms. The co-primary feasibility outcomes were: ≥75% patient acceptability rate, active trial participation of ≥50% of medical oncologists, ≥75% and ≥90% treatment completion, and receipt rate of planned cycles of chemotherapy, respectively. Secondary outcomes: Febrile neutropenia (FN) rate, treatment-related hospitalizations, health-related quality of life (HR-QoL) questionnaires. Analyses were performed by per protocol and intention-to-treat. Results: Between May 2019 and March 2021, 49 of 52 patients agreed to study participation (94% acceptability rate). Fifteen (65%) of 23 medical oncologists approached patients. Rates of FN were higher (8.3% vs. 0%) in the TC-H vs. P-H arm. Median (IQR) changes in scores from baseline in FACT-Taxane Trial Outcome Index at 24 weeks were −4 (−10, −1) vs. −6.5 (−15, −2) for TC-H and P-H arms, respectively. Conclusions: A randomized trial comparing P-H and TC-H was feasible. Expansion to a larger trial would be feasible to explore patient-reported outcomes of these adjuvant HER2 chemotherapy regimens.Excellent long-term outcomes of patients with human epidermal growth factor receptor 2 (HER2) positive early breast cancer (EBC) treated with trastuzumab-based treatments have been reported [Despite their widespread use in lower-risk HER2-positive EBC, neither weekly paclitaxel plus trastuzumab (P-H) nor three-weekly docetaxel-cyclophosphamide plus trastuzumab (TC-H) have been prospectively compared [In the current study, we evaluated the feasibility of conducting a pragmatic clinical trial comparing these two regimens, using an Integrated Consent Model (ICM), in a population of patients with HER2-positive EBC. In addition, even if such a trial was feasible, it would require a large sample size, so we wished to assess other clinically relevant outcomes, such as toxicity, quality of life (QoL), patient-reported outcomes, and cost-effectiveness that could drive meaningful changes in clinical practice.