A Multi-Centre Randomized Study Comparing Two Standard of Care Chemotherapy Regimens for Lower-Risk HER2-Positive Breast Cancer

Ricardo Fernandes; Terry L Ng; Mashari Jemaan Alzahrani; Jacques Raphael; Phillip Blanchette; Morgan Black; Carol Stober; Gregory R Pond; David Cella; Lisa Vandermeer; Mohammed Ibrahim; Mark Clemons; REaCT Investigators

doi:10.3390/curroncol30080535

A Multi-Centre Randomized Study Comparing Two Standard of Care Chemotherapy Regimens for Lower-Risk HER2-Positive Breast Cancer

Curr Oncol. 2023 Aug 4;30(8):7384-7397. doi: 10.3390/curroncol30080535.

Authors

Ricardo Fernandes^{1

2}, Terry L Ng^{3

4}, Mashari Jemaan Alzahrani³, Jacques Raphael^{1

2}, Phillip Blanchette¹, Morgan Black¹, Carol Stober⁴, Gregory R Pond⁵, David Cella⁶, Lisa Vandermeer⁴, Mohammed Ibrahim⁷, Mark Clemons^{3

4}; REaCT Investigators

Affiliations

¹ Department of Oncology, Division of Medical Oncology, Schulich School of Medicine & Dentistry, Western University and London Health Sciences Centre, London, ON N6A 5W9, Canada.
² Cancer Research Laboratory Program, Lawson Health Research Institute, London, ON N6C 2R5, Canada.
³ Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, ON K1H 8L6, Canada.
⁴ Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, ON K1H 8L6, Canada.
⁵ Department of Oncology, McMaster University, Hamilton, ON L8V 5C2, Canada.
⁶ Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL 60611, USA.
⁷ Division of Clinical Sciences, Northern Ontario School of Medicine, Thunder Bay, ON P7B 5E1, Canada.

Abstract

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.

Keywords: HER2-positive; chemotherapy; early-stage breast cancer; trastuzumab.

Publication types

Randomized Controlled Trial
Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Breast Neoplasms* / drug therapy
Chemotherapy, Adjuvant
Female
Humans
Quality of Life
Standard of Care
Trastuzumab / therapeutic use

Substances

Trastuzumab

Grants and funding

Funding for this study was provided by London Regional Cancer Program Medical Oncology Research Fund (MORF) and infrastructure support from the ReThinking Clinical Trials (REaCT) program at the Ottawa Hospital Research Institute. We are also grateful to the Canadian Cancer Clinical Trials Network (3CTN) for funding and operational support to conduct multicenter academic clinical trials at cancer centres across Canada.