Evidence mapPaperPMID 34383179Full record

Trial reportBreast cancer research and treatment2021

A randomized controlled trial of metformin in women with components of metabolic syndrome: intervention feasibility and effects on adiposity and breast density.

Edgar Tapia, Diana Evelyn Villa-Guillen, Pavani Chalasani, Sara Centuori, Denise J Roe, Jose Guillen-Rodriguez, Chuan Huang, Jean-Phillippe Galons, Cynthia A Thomson, Maria Altbach and 5 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Breast cancer research and treatment, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02028221 (Phase II Study of Metformin for Reduction of Obesity-Associated Breast Cancer Risk), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.7field-weighted citation impact, top 15% 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.

NCT02028221 phase2completednot on this map

Phase II Study of Metformin for Reduction of Obesity-Associated Breast Cancer Risk

TypeinterventionalSponsorUniversity of ArizonaRan2014 to 2022Enrolled151ConditionsBreast Cancer PreventionArmsMetformin, Placebo
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 25 citations in OpenAlex.

  1. Review
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  11. Exploration of targeted anti-tumor therapy · 2022
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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 at 3 institutions in 2 countries.

Edgar TapiaUniversity of Arizona Cancer Center, University of Arizona, 1515 N Campbell Ave, Tucson, AZ, 85724, USA.
Diana Evelyn Villa-GuillenDepartment of Biological-Chemistry Sciences, University of Sonora, Hermosillo, Sonora, Mexico.
Pavani ChalasaniUniversity of Arizona Cancer Center, University of Arizona, 1515 N Campbell Ave, Tucson, AZ, 85724, USA.
Sara CentuoriUniversity of Arizona Cancer Center, University of Arizona, 1515 N Campbell Ave, Tucson, AZ, 85724, USA.
Denise J RoeUniversity of Arizona Cancer Center, University of Arizona, 1515 N Campbell Ave, Tucson, AZ, 85724, USA.
Jose Guillen-RodriguezUniversity of Arizona Cancer Center, University of Arizona, 1515 N Campbell Ave, Tucson, AZ, 85724, USA.
Chuan HuangDepartment of Radiology, Stony Brook University, Stony Brook, NY, USA.
Jean-Phillippe GalonsUniversity of Arizona Cancer Center, University of Arizona, 1515 N Campbell Ave, Tucson, AZ, 85724, USA.
Cynthia A ThomsonUniversity of Arizona Cancer Center, University of Arizona, 1515 N Campbell Ave, Tucson, AZ, 85724, USA.
Maria AltbachUniversity of Arizona Cancer Center, University of Arizona, 1515 N Campbell Ave, Tucson, AZ, 85724, USA.
Jesse TrujilloUniversity of Arizona Cancer Center, University of Arizona, 1515 N Campbell Ave, Tucson, AZ, 85724, USA.
Liane PintoUniversity of Arizona Cancer Center, University of Arizona, 1515 N Campbell Ave, Tucson, AZ, 85724, USA.
Jessica A MartinezUniversity of Arizona Cancer Center, University of Arizona, 1515 N Campbell Ave, Tucson, AZ, 85724, USA.
Amit M AlgotarUniversity of Arizona Cancer Center, University of Arizona, 1515 N Campbell Ave, Tucson, AZ, 85724, USA.
H-H Sherry ChowUniversity of Arizona Cancer Center, University of Arizona, 1515 N Campbell Ave, Tucson, AZ, 85724, USA. schow@azcc.arizona.edu.ORCID http://orcid.org/0000-0002-9638-711X
University of Arizona · USStony Brook University · USUniversidad de Sonora · MX

Funding

VITAMIN AP30CA023074 · UNIVERSITY OF ARIZONA · 1985 to 2025
$23.1M
NCI NIH HHS P30 CA023074NCI NIH HHS P30CA023074NCI NIH HHS R01 CA172444NCI NIH HHS R01CA172444NCI NIH HHS T32 CA078447
6 · The paper itself

Abstract

purposeObesity is a known risk factor for post-menopausal breast cancer and may increase risk for triple negative breast cancer in premenopausal women. Intervention strategies are clearly needed to reduce obesity-associated breast cancer risk.

methodsWe conducted a Phase II double-blind, randomized, placebo-controlled trial of metformin in overweight/obese premenopausal women with components of metabolic syndrome to assess the potential of metformin for primary breast cancer prevention. Eligible participants were randomized to receive metformin (850 mg BID, n = 76) or placebo (n = 75) for 12 months. Outcomes included breast density, assessed by fat/water MRI with change in percent breast density as the primary endpoint, anthropometric measures, and intervention feasibility.

resultsSeventy-six percent in the metformin arm and 83% in the placebo arm (p = 0.182) completed the 12-month intervention. Adherence to study agent was high with more than 80% of participants taking ≥ 80% assigned pills. The most common adverse events reported in the metformin arm were gastrointestinal in nature and subsided over time. Compared to placebo, metformin intervention led to a significant reduction in waist circumference (p < 0.001) and waist-to-hip ratio (p = 0.019). Compared to placebo, metformin did not change percent breast density and dense breast volume but led to a numerical but not significant decrease in non-dense breast volume (p = 0.070).

conclusionWe conclude that metformin intervention resulted in favorable changes in anthropometric measures of adiposity and a borderline decrease in non-dense breast volume in women with metabolic dysregulation. More research is needed to understand the impact of metformin on breast cancer risk reduction.

trial registrationClinicalTrials.gov NCT02028221. Registered January 7, 2014, https://clinicaltrials.gov/ct2/show/NCT02028221.

Indexed as

Breast NeoplasmsMetabolic SyndromeMetforminAdiposityBreast DensityFeasibility StudiesFemaleHumansMammographyObesityMetforminAnthropometric measuresBreast densityClinical trialMetabolic syndromeMetformin

Identifiers

PMID34383179
PMCPMC8560579
OpenAlexW3189074035

What Socratic holds

Texttitle and abstract
LicenceTDM
Read underepoch 390

Registered trials

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 Socratic graph.