Multicentre, randomised, double-blind, placebo-controlled phase II study of prophylactic olanzapine for patients with metastatic breast cancer receiving T-DXd treatment: protocol for the ERICA study (WJOG14320B).

The antibody-drug conjugate trastuzumab deruxtecan (T-DXd) has led to a change in the clinical management of breast cancer. Nausea and vomiting are the most common adverse events of T-DXd, which cannot be completely alleviated by standard prophylactic regimens. Olanzapine is particularly effective in preventing delayed nausea caused by chemotherapy. In this study, we will evaluate the efficacy of olanzapine in managing persistent nausea and vomiting during T-DXd treatment. The ERICA study is a multicentre, placebo-controlled, double-blind, randomised phase II study with the aim to evaluate the antiemetic effects of the prophylactic olanzapine (5 mg orally, on days 1-6) or placebo combined with a 1,5-hydroxytryptamine-3 (5-HT The study protocol is approved by the West Japan Oncology Group protocol review committee and the SHOWA University Clinical Research Review Board. The study results will be presented at international conferences and published in a peer-reviewed journal. jRCTs031210410.

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Déclaration de conflit d'intérêts

Competing interests: All authors have completed the ICMJE uniform disclosure form and declare that this research is supported by Daiichi Sankyo. HS has received speaker’s honorarium and medical writing support from Daiichi Sankyo as well as research funding from Eisai. JT has received consulting/advisory fees, conference support, speaker’s honoraria, research funding, and other fees from Daiichi Sankyo, research funding and speaker’s honoraria from Eli Lilly, research funding from Sant Joan de Déu Research Foundation, and consulting/advisory fees from AstraZeneca. YO has received speaker’s honoraria from Chugai and Daiichi Sankyo. KM has received speaker’s honoraria from Daiichi Sankyo, Chugai, Kyowa-Kirin and MSD, and advisory fees from Daiichi Sankyo and contracts for registration trials from MSD, Chugai, Eisai, Daiichi Sankyo, Eli Lilly, ICON Japan. KN, TY, SM, TI and YC have no conflicts of interest to disclose. HI has received speaker’s honoraria from Pfizer Japan, Eisai, Chugai Pharmaceutical, Kyowa Kirin, JMS, Taiho and Daiichi Sankyo. KW has received speaker’s honoraria from Chugai, Eli Lilly, Nippon-Kayaku, Kyowa Kirin, Novartis, Taiho, Eisai, Pfizer, Shionogi, Daiichi Sankyo and AstraZeneca. CMI has received research funding from Otsuka and Eli Lilly, in addition to speaker’s honorarium from Taiho. DT is an employee of Daiichi Sankyo. TT has received speaker’s honoraria from Daiichi Sankyo, Chugai, Eisai, Eli Lilly, and Celltrion Healthcare.