Evidence map›Paper›PMID 25421542›Full record

Trial reportJournal of translational medicine2014

Effects of zoledronic acid and the association between its efficacy and γδT cells in postmenopausal women with breast cancer treated with preoperative hormonal therapy: a study protocol.

Eriko Sumi, Tomoharu Sugie, Kenichi Yoshimura, Harue Tada, Takafumi Ikeda, Eiji Suzuki, Yoshimasa Tanaka, Satoshi Teramukai, Akira Shimizu, Masakazu Toi and 1 more

Open access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of translational medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.3field-weighted citation impact, top 38% 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

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Immune modulation of CD4BMC immunology · 2016
    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

11 authors at 6 institutions in 1 country.

Eriko Sumi
Tomoharu Sugie
Kenichi Yoshimura
Harue Tada
Takafumi Ikeda
Eiji Suzuki
Yoshimasa Tanaka
Satoshi Teramukai
Akira Shimizu
Masakazu Toi
Nagahiro Minato
Kyoto University Hospital · JPKansai Medical University · JPKobe University Hospital · JPKyoto Prefectural University of Medicine · JPKyoto University · JPNagasaki University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlthough the efficacy of zoledronic acid in postmenopausal women with breast cancer has been suggested, the underlying mechanism has not been fully clarified. Therefore, which patients may benefit from zoledronic acid and the optimal frequency of zoledronic acid administration are unclear. This study evaluates the effects of zoledronic acid on the tumor response in postmenopausal women with breast cancer and explores the relationship between its efficacy and γδ T cells. METHODS/

designThis study is an open-label, multi-institutional, single-arm, phase II clinical trial. Zoledronic acid will be administered once during preoperative hormonal therapy with letrozole for 24 weeks in postmenopausal women with Estrogen Receptor (ER)-positive , Human Epidermal Growth Factor Receptor 2 (HER2)-negative, clinical T1 or T2 N0M0 breast cancer. The primary endpoint is the objective response rate measured by MRI at 12 and 24 weeks. The secondary endpoints are the associations between the frequency of Vγ2Vδ2 T cells before the administration of zoledronic acid and the objective response, the association between the frequency of Vγ2Vδ2 T cells and the Preoperative Endocrine Prognostic Index score, and the association between the frequency of Vγ2Vδ2 T cells and Ki67 (MIB-1 index). DISCUSSION: This study is designed to determine the add-on effect of zoledronic acid during preoperative hormonal therapy and to investigate the changes of the frequency of Vγ2Vδ2 T cells after the administration of zoledronic acid to explore the potential mechanism of zoledronic acid in breast cancer patients.

trial registrationThis trial was registered at the UMIN Clinical Trials Registry as UMIN000008701.

Indexed as

Antineoplastic Agents, HormonalBone Density Conservation AgentsBreast NeoplasmsPostmenopauseReceptors, Antigen, T-Cell, gamma-deltaZoledronic AcidDiphosphonatesFemaleHumansImidazolesLetrozoleNitrilesPreoperative CareResearch DesignT-LymphocytesTriazolesAntineoplastic Agents, HormonalBone Density Conservation AgentsDiphosphonatesImidazolesLetrozoleNitrilesReceptors, Antigen, T-Cell, gamma-deltaTriazolesZoledronic Acid

Identifiers

PMID25421542
PMCPMC4246451
OpenAlexW2117044981

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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.