Evidence map›Paper›PMID 37012013›Full record

ArticleBMJ open2023

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).

Hitomi Sakai, Junji Tsurutani, Yukinori Ozaki, Hiroshi Ishiguro, Kazuki Nozawa, Kenichi Watanabe, Shigeto Maeda, Takamichi Yokoe, Chiyo K Imamura, Koji Matsumoto and 4 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.8field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 11 institutions in 1 country.

Hitomi SakaiAdvanced Cancer Translational Research Institute, Showa University, Tokyo, Japan sakai-h@med.showa-u.ac.jp.ORCID 0000-0001-8396-9121
Junji TsurutaniAdvanced Cancer Translational Research Institute, Showa University, Tokyo, Japan.
Yukinori OzakiBreast Medical Oncology Department, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Hiroshi IshiguroBreast Oncology Service, Saitama Medical University International Medical Center, Saitama, Japan.
Kazuki NozawaDepartment of Breast Oncology, Aichi Cancer Center Hospital, Aichi, Japan.ORCID 0000-0002-0277-8196
Kenichi WatanabeDepartment of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Hokkaido, Japan.
Shigeto MaedaDepartment of Surgery, National Hospital Organization Nagasaki Medical Center, Nagasaki, Japan.
Takamichi YokoeDepartment of Surgery, Keio University School of Medicine, Tokyo, Japan.
Chiyo K ImamuraAdvanced Cancer Translational Research Institute, Showa University, Tokyo, Japan.
Koji MatsumotoDepartment of Medical Oncology, Hyogo Cancer Center, Hyogo, Japan.
Tsutomu IwasaDepartment of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan.
Yasutaka ChibaClinical Research Center, Kindai University Hospital, Osaka, Japan.
Daisuke TakiguchiOncology Medical Science Department, Daiichi Sankyo Co Ltd, Tokyo, Japan.
Toshimi TakanoBreast Medical Oncology Department, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.ORCID 0000-0002-8417-5291
Showa University · JPThe Cancer Institute Hospital · JPAichi Cancer Center · JPDaiichi-Sankyo (Japan) · JPHyogo Prefectural Cancer Center · JPKeio University · JPKindai University · JPKindai University Hospital · JPNagasaki Medical Center · JPNational Hospital Organization Hokkaido Medical Center · JPSaitama Medical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe 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. METHODS AND ANALYSIS: 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 ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: jRCTs031210410.

Indexed as

AntiemeticsAntineoplastic AgentsBreast NeoplasmsImmunoconjugatesCamptothecinClinical Trials, Phase II as TopicDouble-Blind MethodFemaleHumansMulticenter Studies as TopicNauseaOlanzapineRandomized Controlled Trials as TopicTrastuzumabVomitingAntiemeticsAntineoplastic AgentsCamptothecinImmunoconjugatesOlanzapineTrastuzumabtrastuzumab deruxtecanAdverse eventsBreast tumoursCHEMOTHERAPYToxicity

Identifiers

PMID37012013
PMCPMC10083740
OpenAlexW4362523190

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.