Evidence map›Paper›PMID 32272505›Full record

Trial reportThe oncologist2020

Exclusion of Men from Randomized Phase III Breast Cancer Clinical Trials.

Kelsey L Corrigan, Walker Mainwaring, Austin B Miller, Timothy A Lin, Amit Jethanandani, Andres F Espinoza, Matt Piotrowski, C David Fuller, Michael C Stauder, Simona F Shaitelman and 5 more

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The oncologist, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
–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

21 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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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

15 authors.

Kelsey L CorriganMD Anderson Cancer Center, McGovern Medical School, University of Texas, Houston, Texas, USA.ORCID 0000-0003-0314-6972
Walker MainwaringBaylor College of Medicine, Houston, Texas, USA.
Austin B MillerHealth Science Center, McGovern Medical School, University of Texas, Houston, Texas, USA.
Timothy A LinThe Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Amit JethanandaniThe University of Tennessee Health Science Center, Memphis, Tennessee, USA.
Andres F EspinozaBaylor College of Medicine, Houston, Texas, USA.
Matt PiotrowskiMD Anderson Cancer Center, McGovern Medical School, University of Texas, Houston, Texas, USA.
C David FullerMD Anderson Cancer Center, McGovern Medical School, University of Texas, Houston, Texas, USA.
Michael C StauderMD Anderson Cancer Center, McGovern Medical School, University of Texas, Houston, Texas, USA.
Simona F ShaitelmanMD Anderson Cancer Center, McGovern Medical School, University of Texas, Houston, Texas, USA.
George H PerkinsMD Anderson Cancer Center, McGovern Medical School, University of Texas, Houston, Texas, USA.
Wendy A WoodwardMD Anderson Cancer Center, McGovern Medical School, University of Texas, Houston, Texas, USA.
Sharon H GiordanoMD Anderson Cancer Center, McGovern Medical School, University of Texas, Houston, Texas, USA.
Benjamin D SmithMD Anderson Cancer Center, McGovern Medical School, University of Texas, Houston, Texas, USA.
Ethan B LudmirMD Anderson Cancer Center, McGovern Medical School, University of Texas, Houston, Texas, USA.ORCID 0000-0002-5472-5344

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Male breast cancer treatment regimens are often extrapolated from female-based studies because of a paucity of literature analyzing male breast cancer. Using ClinicalTrials.gov, we analyzed breast cancer randomized clinical trials (RCTs) to determine which factors were associated with male-gender inclusion. Of 131 breast cancer RCTs identified, male patients represented 0.087% of the total study population, which is significantly less than the proportion of male patients with breast cancer in the U.S. (0.95%; p < .001). Twenty-seven trials included male patients (20.6%). Lower rates of male inclusion were seen in trials that randomized or mandated hormone therapy as part of the trial protocol compared with trials that did not randomize or mandate endocrine therapy (2.5% vs. 28.6% male inclusion; p < .001). It is imperative for breast cancer clinical trials to include men when allowable in order to improve generalizability and treatment decisions in male patients with breast cancer.

Indexed as

Breast NeoplasmsFemaleHumansMale

Identifiers

PMID32272505
PMCPMC7288651

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.