Evidence map›Paper›PMID 32381018›Full record

ArticleTrials2020

Trastuzumab, pertuzumab, and eribulin mesylate versus trastuzumab, pertuzumab, and a taxane as a first-line or second-line treatment for HER2-positive, locally advanced or metastatic breast cancer: study protocol for a randomized controlled, non-inferiority, phase III trial in Japan (JBCRG-M06/EMERALD).

Toshinari Yamashita, Norikazu Masuda, Shigehira Saji, Kazuhiro Araki, Yoshinori Ito, Toshimi Takano, Masato Takahashi, Junji Tsurutani, Kei Koizumi, Masahiro Kitada and 9 more

Erratum issued Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03264547 (A Phase III Clinical Study to Compare the Combination Therapy of Eribulin Mesylate + Pertuzumab + Trastuzumab With Paclitaxel or Docetaxel + Pertuzumab + Trastuzumab), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 27% 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.

NCT03264547 phase3completednot on this map

A Phase III Clinical Study to Compare the Combination Therapy of Eribulin Mesylate + Pertuzumab + Trastuzumab With Paclitaxel or Docetaxel + Pertuzumab + Trastuzumab (EMERALD)

TypeinterventionalSponsorJapan Breast Cancer Research GroupRan2017 to 2024Enrolled446ConditionsBreast CancerArmsPertuzumab, Trastuzumab, Docetaxel, Paclitaxel, Eribulin
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 16 institutions in 1 country.

Toshinari YamashitaDepartment of Breast Surgery, Kanagawa Cancer Center, 2-3-2 Nakao Asahi-ku, Yokohama-shi, Kanagawa, 241-8515, Japan. tyamashita@kcch.jp.
Norikazu MasudaDepartment of Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, 2-1-14 Hoenzaka, Chuou-ku, Osaka, 540-0006, Japan.
Shigehira SajiDepartment of Medical Oncology, Fukushima Medical University, 1 Hikarigaoka Fukushima, Fukushima, 960-1295, Japan.
Kazuhiro ArakiDepartment of Breast Surgery, Gunma Prefectural Cancer Center, 617-1 Takahayashinishicho, Ota, Gunma, 373-8550, Japan.
Yoshinori ItoBreast Medical Oncology, Breast Oncology Center, The Cancer Institute Hospital of JFCR, 3-8-31 Ariake Koto-ku, Tokyo, 135-8550, Japan.
Toshimi TakanoDepartment of Medical Oncology, Toranomon Hospital, 2-2-2 Toranomon Minato-ku, Tokyo, 105-8470, Japan.
Masato TakahashiBreast Surgery, NHO Hokkaido Cancer Center, 2-3-54 Yonjyo Kikusui Shiraishi-ku, Sapporo-shi, Hokkaido, 003-0804, Japan.
Junji TsurutaniDepartment of Medical Oncology, Showa University Hospital, 1-5-8 Hatanodai Shinagawa-ku, Tokyo, 142-8666, Japan.
Kei KoizumiFirst Department of Surgery, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka, 431-3192, Japan.
Masahiro KitadaBreast Disease Center, Asahikawa Medical University Hospital, 1-1 Higashi 2-jyo 1-chome, Midorigaoka, Asahikawa-shi, Hokkaido, 078-8510, Japan.
Yasuyuki KojimaDepartment of Breast Surgery, St. Marianna University School of Medicine Hospital, 2-16-1 Sugao Miyamae-ku, Kawasaki-shi, Kanagawa, 216-8511, Japan.
Yasuaki SagaraBreast Surgical Oncology, Sagara Hospital, 3-31 Matsubaracho Kagoshima-shi, Kagoshima, 892-0833, Japan.
Hiroshi TadaDepartment of Breast and Endocrine Surgical Oncology, Tohoku University Hospital, 1-1 Seiryocho Aoba-ku Sendai-shi, Miyagi, 980-8574, Japan.
Tsutomu IwasaOncology Internal Medicine, Kindai University Hospital, 377-2 Ohnohigashi Sayama-shi Osaka, Osaka, 589-8511, Japan.
Takayuki KadoyaBreast Surgery, Hiroshima University Hospital, 1-2-3 Kasumi Minami-ku Hiroshima-shi, Hiroshima, 734-8551, Japan.
Tsuguo IwataniDepartment of Breast Surgery, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
Hiroki HasegawaEisai Co., Ltd., 4-6-10 Koishikawa Bunkyo-ku, Tokyo, 112-8088, Japan.
Satoshi MoritaDepartment of Biomedical Statistics and Bioinformatics, Graduate School of Medicine Kyoto University, 54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan.
Shinji OhnoBreast Oncology Center, The Cancer Institute Hospital of JFCR, 3-8-31 Ariake Koto-ku, Tokyo, 135-8550, Japan.
The Cancer Institute Hospital · JPAsahikawa Medical University · JPEisai (Japan) · JPFukushima Medical University · JPHamamatsu University School of Medicine · JPHiroshima University Hospital · JPKanagawa Prefectural Hospital Organization · JPKindai University Hospital · JPKyoto University · JPNational Cancer Center Hospital East · JPNational Sagamihara Hospital · JPOsaka National Hospital · JPShowa University Hospital · JPSt. Marianna University School of Medicine · JPTohoku University Hospital · JPToranomon Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTrastuzumab (Tmab), pertuzumab (Pmab), and taxane has been a standard first-line treatment for recurrent or metastatic human epidermal growth factor (HER2)-positive breast cancer (HER2 METHODS/

designThis multicenter, randomized, open-label, parallel-group, phase III study will involve a total of 480 Japanese women with HER2 DISCUSSION: If this study shows the non-inferiority, or even superiority, of Tmab, Pmab, and eribulin against the existing taxane-containing regimen, this new regimen may become a standard first- or second-line treatment option for HER2

trial registrationClinicalTrials.gov, ID: NCT03264547. Registered on 28 June 2017.

Indexed as

Breast NeoplasmsErb-b2 Receptor Tyrosine KinasesNeoplasm MetastasisAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsBridged-Ring CompoundsClinical Trials, Phase III as TopicEquivalence Trials as TopicFemaleFuransHumansJapanKetonesAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalBridged-Ring CompoundsERBB2 protein, humanErb-b2 Receptor Tyrosine KinaseseribulinFuransKetonespertuzumabPolyether PolyketidestaxaneTaxoidsTrastuzumabTubulin ModulatorsCombination therapyEribulinHER2-positiveMetastatic breast cancerNon-inferiorityPertuzumabTaxaneTrastuzumab

Identifiers

PMID32381018
PMCPMC7206765
OpenAlexW4248292794

What OpenQuestion holds

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Registered trials

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.