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Randomized Controlled Trial
. 2023 Aug 4;30(8):7384-7397.
doi: 10.3390/curroncol30080535.

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

Ricardo Fernandes  1   2 , Terry L Ng  3   4 , Mashari Jemaan Alzahrani  3 , Jacques Raphael  1   2 , Phillip Blanchette  1 , Morgan Black  1 , Carol Stober  4 , Gregory R Pond  5 , David Cella  6 , Lisa Vandermeer  4 , Mohammed Ibrahim  7 , Mark Clemons  3   4 ; REaCT Investigators
Affiliations
Randomized Controlled Trial

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

Ricardo Fernandes et al. Curr Oncol. .

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.

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Conflict of interest statement

Ricardo Fernandes received honoraria from Canadian Agency for Drugs and Technologies in Health (CADTH), Bayer, Pfizer, Ipsen, BMS, Merck, Novartis, and Janssen. Gregory Pond received consulting fees from Merck, Profound Medical and Astra-Zeneca, received honoraria for participation on an advisory board for Takeda, and has a close family member who is an employee of Roche Canada, and who owns stock in Roche Ltd. David Cella is the President of FACIT.org. The other authors declare no competing interests.

Figures

Figure 1
Figure 1
Trial Profile CONSORT 2010 Flow Diagram.
See this image and copyright information in PMC

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