Evidence map›Paper›PMID 34485814›Full record

Trial reportJNCI cancer spectrum2021

Cancer Antigen 15-3/Mucin 1 Levels in CCTG MA.32: A Breast Cancer Randomized Trial of Metformin vs Placebo.

Pamela J Goodwin, Ryan J O Dowling, Marguerite Ennis, Bingshu E Chen, Wendy R Parulekar, Lois E Shepherd, Karen A Gelmon, Timothy J Whelan, Jennifer A Ligibel, Dawn L Hershman and 8 more

Open access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in JNCI cancer spectrum, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 31% 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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Review
  7. Review
  8. Article
  9. 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

18 authors at 16 institutions in 4 countries.

Pamela J GoodwinLunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, and Department of Medicine, University of Toronto, Toronto, ON, Canada.ORCID 0000-0003-2637-6906
Ryan J O DowlingHoffman-La Roche Limited, Mississauga, ON, Canada.
Marguerite EnnisApplied Statistician, Markham, ON, Canada.ORCID 0000-0003-1094-5131
Bingshu E ChenCanadian Cancer Trials Group, Queen's University, Kingston, ON, Canada.ORCID 0000-0001-6139-0696
Wendy R ParulekarCanadian Cancer Trials Group, Queen's University, Kingston, ON, Canada.
Lois E ShepherdCanadian Cancer Trials Group, Queen's University, Kingston, ON, Canada.
Karen A GelmonUniversity of British Columbia, BC Cancer Agency, Vancouver, BC, Canada.
Timothy J WhelanMcMaster University, Juravinski Cancer Centre, Hamilton, ON, Canada.
Jennifer A LigibelDana-Farber Cancer Institute, Boston, MA, USA.
Dawn L HershmanHerbert Irving Comprehensive Cancer Center, Columbia University Medical Center, NY, USA.ORCID 0000-0001-8807-153X
Ingrid A MayerVanderbilt University, Nashville, TN, USA.ORCID 0000-0001-8147-335X
Timothy J HobdayMayo Clinic, Rochester, MN, USA.
Priya RastogiNRG Oncology and University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Manuela Rabaglio-PorettiIBCSG and Department of Oncology, Bern University Hospital, University of Bern, Bern, Switzerland.ORCID 0000-0002-6764-1844
Julie LemieuxCHU de Québec-Université Laval, Québec, QC, Canada.
Alastair M ThompsonBaylor College of Medicine, Houston, TX, USA.
Daniel W ReaCancer Research UK Clinical Trials Unit (CRCTU), Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.
Vuk StambolicDepartment of Medical Biophysics, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada and University of Toronto, Toronto, ON, Canada.ORCID 0000-0001-8853-3239
Queen's University · CABaylor College of Medicine · USBC Cancer Agency · CACancer Research UK Clinical Trials Unit · GBColumbia University Irving Medical Center · USDana-Farber Cancer Institute · USJuravinski Cancer Centre · CAMayo Clinic in Arizona · USMount Sinai Hospital · CARoche (Canada) · CAStatistics Canada · CAUniversité Laval · CAUniversity Health Network · CAUniversity of Bern · CHUniversity of Pittsburgh Medical Center · USVanderbilt University · US

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Elaina Harper · 2014 to 2026
$146.4M
TISSUE CoreP50CA098131 · NCI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI PARK, BEN HO, PIETENPOL, JENNIFER A · 2003 to 2024
$48.7M
NCIC Foreign AccrualsU10CA077202 · NCI · QUEEN'S UNIVERSITY AT KINGSTON · PI EISENHAUER, ELIZABETH · 1998 to 2013
$14.6M
NCI NIH HHS P50 CA098131NCI NIH HHS U10 CA077202NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868NCI NIH HHS U10 CA180888
6 · The paper itself

Abstract

Background: Circulating levels of cancer antigen (CA) 15-3, a tumor marker and regulator of cellular metabolism, were reduced by metformin in a nonrandomized neoadjuvant study. We examined the effects of metformin (vs placebo) on CA 15-3 in participants of MA.32, a phase III randomized trial in early-stage breast cancer. Methods: A total of 3649 patients with T1-3, N0-3, M0 breast cancer were randomly assigned; pretreatment and 6-month on-treatment fasting plasma were centrally assayed for CA 15-3. Genomic DNA was analyzed for the rs11212617 single nucleotide polymorphism. Absolute and relative change of CA 15-3 (metformin vs placebo) were compared using Wilcoxon rank and Results: Mean (SD) age was 52.4 (10.0) years. The majority of patients had T2/3, node-positive, hormone receptor-positive, HER2-negative breast cancer treated with (neo)adjuvant chemotherapy and hormone therapy. Mean (SD) baseline CA 15-3 was 17.7 (7.6) and 18.0 (8.1 U/mL). At 6 months, CA 15-3 was statistically significantly reduced in metformin vs placebo arms (absolute geometric mean reduction in CA 15-3 = 7.7% vs 2.0%, Conclusions: Our observation that metformin reduces CA 15-3 by approximately 6% was corroborated in a large placebo-controlled randomized trial. The clinical implications of this reduction in CA 15-3 will be explored in upcoming efficacy analyses of breast cancer outcomes in MA.32.

Indexed as

Body Mass IndexBreast NeoplasmsChemotherapy, AdjuvantFastingFemaleHumansMetforminMiddle AgedMucin-1PlacebosPolymorphism, Single NucleotideMetforminMUC1 protein, humanMucin-1Placebos

Identifiers

PMID34485814
PMCPMC8410139
OpenAlexW3184802087

What OpenQuestion holds

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LicenceCC BY-NC
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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.