Evidence map›Paper›PMID 22676245›Full record

Trial reportCancer science2012

Randomized phase II study of three doses of oral TAS-108 in postmenopausal patients with metastatic breast cancer.

Hideo Inaji, Hiroji Iwata, Takahiro Nakayama, Naohito Yamamoto, Yasuyuki Sato, Yutaka Tokuda, Kenjiro Aogi, Shigehira Saji, Kenichi Watanabe, Tsuyoshi Saito and 10 more

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cancer science, 2012. 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
0.6field-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.

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, 9 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. 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

20 authors at 20 institutions in 1 country.

Hideo InajiDepartment of Breast and Endocrine Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Japan.
Hiroji Iwata
Takahiro Nakayama
Naohito Yamamoto
Yasuyuki Sato
Yutaka Tokuda
Kenjiro Aogi
Shigehira Saji
Kenichi Watanabe
Tsuyoshi Saito
Masayuki Yoshida
Nobuaki Sato
Toshiaki Saeki
Yuichi Takatsuka
Masaru Kuranami
Hiroko Yamashita
Atsushi Kikuchi
Toshio Tabei
Tadashi Ikeda
Shinzaburo Noguchi
Aichi Cancer Center · JPChiba Cancer Center · JPHokkaido University Hospital · JPKansai Rosai Hospital · JPKitasato University · JPNagoya City University · JPNagoya Medical Center · JPNiigata Cancer Center Hospital · JPOsaka Gakuin University · JPOsaka International Cancer Institute · JPSaitama Cancer Center · JPSaitama International Medical Center · JPSaitama Red Cross Hospital · JPSakai Municipal Hospital · JPSeirei Hamamatsu General Hospital · JPShikoku Cancer Center · JPTeikyo University · JPTokai University · JPTokyo Metropolitan Komagome Hospital · JPYamagata Prefectural Central Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This randomized phase II study was intended to identify the optimal dose of TAS-108, a novel steroidal antiestrogen, for the treatment of breast cancer in postmenopausal Japanese women. The potential clinical effects of TAS-108 on the uterus, bone, serum lipids, and hormones were also investigated. Postmenopausal women with hormone receptor-positive metastatic breast cancer who had previously received one or two endocrine therapies were randomly assigned to one of the three possible dose levels of TAS-108 (40, 80 or 120 mg/day). Oral TAS-108 was given daily, and the efficacy and safety of the three doses were evaluated. A total of 97 patients (33, 32, and 32 in the 40-, 80-, and 120-mg groups, respectively) were treated with TAS-108. The clinical benefit rate was 30.3% for the 40-mg, 25.0% for the 80-mg, and 25.0% for the 120-mg group. The 40-mg group achieved the prespecified target threshold. TAS-108 at all dose levels was well tolerated and appeared to have no harmful effects in terms of the variables examined in this study. We conclude that the optimal dose of TAS-108 among the three doses is 40 mg, once daily, for further studies. JAPIC Clinical Trials Information number: Japic CTI - 121754.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Agents, HormonalBreast NeoplasmsEstradiolFemaleHumansMiddle AgedNeoplasm MetastasisPostmenopauseTreatment OutcomeAntineoplastic Agents, HormonalEstradiolTS 108

Identifiers

PMID22676245
PMCPMC7659257
OpenAlexW2064945155

What OpenQuestion holds

Textmetadata
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.