Evidence map›Paper›PMID 32769873›Full record

ArticleMedicine2020

A phase 2 basket trial of combination therapy with trastuzumab and pertuzumab in patients with solid cancers harboring human epidermal growth factor receptor 2 amplification (JUPITER trial).

Kenta Takahashi, Eri Ishibashi, Toshio Kubo, Yohei Harada, Hideyuki Hayashi, Masayuki Kano, Yasushi Shimizu, Hidekazu Shirota, Yukiko Mori, Manabu Muto and 10 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 24% 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

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

  1. Pooled it
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  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. Cancer Therapy Guided by Mutation Tests: Current Status and Perspectives.International journal of molecular sciences · 2021
    Review
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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

20 authors at 10 institutions in 2 countries.

Kenta TakahashiCenter for Innovative Cancer Treatment.
Eri IshibashiMedical Innovation Promotion Center, Tokyo Medical and Dental University, Tokyo.
Toshio KuboDepartment of General Thoracic Surgery and Breast and Endocrinological Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Science, Okayama.
Yohei HaradaDivision of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga.
Hideyuki HayashiGenomics Unit, Keio Cancer Center, Keio University School of Medicine, Tokyo.
Masayuki KanoDepartment of Frontier Surgery, Chiba University, Chiba.
Yasushi ShimizuDepartment of Medical Oncology, Faculty of Medicine & Graduate School of Medicine, Hokkaido University, Hokkaido.
Hidekazu ShirotaDepartment of Clinical Oncology, Tohoku University Hospital, Sendai.
Yukiko MoriDepartment of Therapeutic Oncology, Graduate School of Medicine, Kyoto University, Kyoto.
Manabu MutoDepartment of Therapeutic Oncology, Graduate School of Medicine, Kyoto University, Kyoto.
Chikashi IshiokaDepartment of Clinical Oncology, Tohoku University Hospital, Sendai.
Hirotoshi Dosaka-AkitaDepartment of Medical Oncology, Faculty of Medicine & Graduate School of Medicine, Hokkaido University, Hokkaido.
Hisahiro MatsubaraDepartment of Frontier Surgery, Chiba University, Chiba.
Hiroshi NishiharaGenomics Unit, Keio Cancer Center, Keio University School of Medicine, Tokyo.
Naoko Sueoka-AraganeDivision of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga.
Shinichi ToyookaDepartment of General Thoracic Surgery and Breast and Endocrinological Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Science, Okayama.
Akihiro HirakawaClinical Research Center.
Ukihide TateishiDepartment of Diagnostic Radiology, Tokyo Medical and Dental University, Tokyo, Japan.
Satoshi MiyakeCenter for Innovative Cancer Treatment.
Sadakatsu IkedaCenter for Innovative Cancer Treatment.
Chiba University · JPHokkaido University · JPKeio University · JPKyoto University · JPOkayama University · JPSaga University · JPTohoku University Hospital · JPTokyo Medical and Dental University · JPClinical Research Management · USUniversity of California, San Diego · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionHuman epidermal growth factor receptor 2 (HER2) gene amplification and mutations have emerged as oncogenic drivers and therapeutic targets not limited to breast and gastric cancers, but also in a variety of cancers. However, even if an actionable gene alteration is found, the incidence of HER2 amplification in these cancers is less than 5%. It is too difficult to conduct a conventional randomized, controlled trial in a rare fraction. Therefore, we have designed a organ-agnostic basket study, which covers a variety of solid cancers harboring HER2 amplification, in 1 study protocol. METHODS/

designThis trial is a multicenter, single-arm, basket phase 2 study in Japan. Patients with solid cancers harboring HER2 amplification that have progressed with standard treatment, or rare cancers for which there is no standard treatment, will be eligible. Target cancers include bile duct, urothelial, uterine, ovarian, and other solid cancers where HER2 amplification is detected by comprehensive genomic profiling using next-generation sequencing technology. A total of 38 patients will be treated with combination therapy with trastuzumab and pertuzumab every 3 weeks until disease progression, unmanageable toxicity, death, or patient refusal. The primary endpoint is the objective response rate, and secondary endpoints are progression-free survival, overall survival, and duration of response. DISCUSSION: The aim of this trial is to evaluate the safety and efficacy of combination therapy with trastuzumab and pertuzumab in patients with locally advanced or metastatic, solid cancers harboring HER2 amplification. Instead of focusing on 1 organ type, our trial design uses a basket study focusing on HER2 amplification, regardless of the site or origin of the cancer. The results of our study will advance clinical and scientific knowledge concerning the treatment of locally advanced, rare solid cancers harboring HER2 amplification, using the combination of trastuzumab and pertuzumab.

trial registrationThis trial was registered in Japan Registry of Clinical Trials (jCRT) on February 25, 2019, as jRCT2031180150.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalClinical Trials, Phase II as TopicDrug Therapy, CombinationErb-b2 Receptor Tyrosine KinasesHumansJapanMulticenter Studies as TopicNeoplasmsTrastuzumabAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalERBB2 protein, humanErb-b2 Receptor Tyrosine KinasespertuzumabTrastuzumab

Identifiers

PMID32769873
PMCPMC7592999
OpenAlexW3047533221

What OpenQuestion holds

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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.