Evidence map›Paper›PMID 32833136›Full record

Trial reportInvestigational new drugs2021

Efficacy of the eribulin, pertuzumab, and trastuzumab combination therapy for human epidermal growth factor receptor 2-positive advanced or metastatic breast cancer: a multicenter, single arm, phase II study (JBCRG-M03 study).

Toshinari Yamashita, Hidetoshi Kawaguchi, Norikazu Masuda, Masahiro Kitada, Kazutaka Narui, Masaya Hattori, Tetsuhiro Yoshinami, Nobuki Matsunami, Kazuhiro Yanagihara, Teru Kawasoe and 9 more

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Investigational new drugs, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–field-weighted citation impact
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

10 citing papers in PubMed.

  1. Trial
  2. Modern synthetic pathways towards eribulin and its subunits.Beilstein journal of organic chemistry · 2026
    Review
  3. Article
  4. Article
  5. Article
  6. Thoughts on therapy strategy in the era of "after anti-HER2 TKI" in CSCO BC Guidelines 2022.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2022
    Review
  7. Is Curcumin the Answer to Future Chemotherapy Cocktail?Molecules (Basel, Switzerland) · 2021
    Review
  8. Review
  9. Article
  10. Oncoimmunology Meets Organs-on-Chip.Frontiers in molecular biosciences · 2021
    Review
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

19 authors.

Toshinari YamashitaDepartment of Breast and Endocrine Surgery, Kanagawa Cancer Center, 2-3-2 Nakao, Asahi-ku, Yokohama, 241-8515, Japan. tyamashita@kcch.jp.ORCID 0000-0002-6479-1660
Hidetoshi KawaguchiDepartment of Breast Surgery, Matsuyama Red Cross Hospital, Matsuyama, Japan.
Norikazu MasudaDepartment of Surgery, Breast Oncology, NHO Osaka National Hospital, Osaka, Japan.
Masahiro KitadaBreast Disease Center, Asahikawa Medical University Hospital, Asahikawa, Japan.
Kazutaka NaruiBreast and Thyroid Surgery, Yokohama City University Medical Center, Yokohama, Japan.
Masaya HattoriDepartment of Breast Oncology, Aichi Cancer Center, Nagoya, Japan.
Tetsuhiro YoshinamiDepartment of Medical Oncology, Osaka International Cancer Institute, Osaka, Japan.
Nobuki MatsunamiDepartment of Breast Surgery, Osaka Rosai Hospital, Sakai, Japan.
Kazuhiro YanagiharaDepartment of Medical Oncology, Kansai Electric Power Hospital, Osaka, Japan.
Teru KawasoeDepartment of Breast and Endocrine Surgery, Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan.
Takeshi NagashimaDepartment of General Surgery, Chiba University Hospital, Chiba, Japan.
Hiroko BandoBreast and Endocrine Surgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
Hiroshi YanoDepartment of Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Yoshie HasegawaDepartment of Breast Surgery, Hirosaki Municipal Hospital, Hirosaki, Japan.
Rikiya NakamuraDepartment of Breast Surgery, Chiba Cancer Center, Chiba, Japan.
Masahiro KashiwabaBreast Surgery, Sagara Hospital, Kagoshima, Japan.
Satoshi MoritaDepartment of Biomedical Statistics and Bioinformatics, Graduate School of Medicine Kyoto University, Kyoto, Japan.
Shinji OhnoCenter of Breast Oncology, The Cancer Institute Hospital of JFCR, Tokyo, Japan.
Masakazu ToiDepartment of Surgery (Breast Surgery), Graduate School of Medicine Kyoto University, Kyoto, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose To date, it is not clear which anticancer agent is useful in combination with trastuzumab and pertuzumab As the first and second selective regimens for advanced or metastatic breast cancer (AMBC), this multicenter, open-label, phase II trial (JBCRG-M03: UMIN000012232) presents a prespecified analysis of eribulin in combination with pertuzumab and trastuzumab. Methods We enrolled 50 patients with no or single prior chemotherapy for HER2-positive AMBC during November 2013-April 2016. All patients received adjuvant or first-line chemotherapy with trastuzumab and a taxane. The treatment comprised eribulin on days 1 and 8 of a 21-day cycle and trastuzumabplus pertuzumab once every 3 weeks, all administered intravenously. While the primary endpoint was the progression-free survival (PFS), secondary endpoints were the response rate and safety. Results Of 50 patients, 49 were eligible for safety analysis, and the full analysis set (FAS) included 46 patients. We treated 8 (16%) and 41 (84%) patients in first- and second-line settings, respectively. While 11 patients (23.9%) had advanced disease, 35 (76.1%) had metastatic disease. The median PFS was 9.2 months for all patients [95% confidence interval (CI): 7.0-11.4]. In the FAS, 44 patients had the measurable lesions and the complete response rate (CR) was 17.4%, and partial response rate (PR) was 43.5%. The grade 3/4 adverse events were neutropenia (5 patients, 10.2%), including febrile neutropenia (2 patients, 4.1%), hypertension (3 patients, 6.1%), and other (1 patient). The average of the left ventricular ejection fraction did not decline markedly. No symptomatic left ventricular systolic dysfunction was observed. Conclusions In patients with HER2-positive AMBC, eribulin, pertuzumab, and trastuzumab combination therapy exhibited substantial antitumor activity with an acceptable safety profile. Hence, we have started a randomized phase III study comparing eribulin and a taxane in combination with pertuzumab and trastuzumab for the treatment of HER2-positive AMBC. Trial registration ID: UMIN-CTR: UMIN000012232.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsErb-b2 Receptor Tyrosine KinasesFemaleFuransHumansKetonesMiddle AgedNitrosourea CompoundsPolyether PolyketidesTrastuzumabAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalERBB2 protein, humanErb-b2 Receptor Tyrosine KinaseseribulinFuransKetonesNitrosourea CompoundsN-neopentyl-N-nitrosoureapertuzumabPolyether PolyketidesTrastuzumabAnti-HER2 drugChemotherapyEribulinMetastatic breast cancerPertuzumab

Identifiers

PMID32833136
PMCPMC7851001

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Registered trials

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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.