Evidence map›Paper›PMID 33655778›Full record

Trial reportMedical decision making : an international journal of the Society for Medical Decision Making2021

Personalized Decision Making on Genomic Testing in Early Breast Cancer: Expanding the MINDACT Trial with Decision-Analytic Modeling.

Ewout W Steyerberg, Liesbeth C de Wreede, David van Klaveren, Patrick M M Bossuyt

Open access · hybridAbstract readRandomized Controlled TrialPragmatic Clinical Trial
In one paragraph

Trial report in Medical decision making : an international journal of the Society for Medical Decision Making, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.2field-weighted citation impact, top 42% 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

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Genomic medicine and personalized treatment: a narrative review.Annals of medicine and surgery (2012) · 2025
    Review
  2. 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

4 authors at 3 institutions in 2 countries.

Ewout W SteyerbergDepartment of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands.ORCID 0000-0002-7787-0122
Liesbeth C de WreedeDepartment of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands.
David van KlaverenDepartment of Public Health, Erasmus MC, Rotterdam, The Netherlands.
Patrick M M BossuytDepartment of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam Public Health Research Institute, Amsterdam University Medical Centers, Amsterdam, The Netherlands.
Leiden University Medical Center · NLAmsterdam University Medical Centers · NLTufts Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGenomic tests may improve upon clinical risk estimation with traditional prognostic factors. We aimed to explore how evidence on the prognostic strength of a genomic signature (clinical validity) can contribute to individualized decision making on starting chemotherapy for women with breast cancer (clinical utility).

methodsThe MINDACT trial was a randomized trial that enrolled 6693 women with early-stage breast cancer. A 70-gene signature (Mammaprint) was used to estimate genomic risk, and clinical risk was estimated by a dichotomized version of the Adjuvant!Online risk calculator. Women with discordant risk results were randomized to the use of chemotherapy. We simulated the full risk distribution of these women and estimated individual benefit, assuming a constant relative effect of chemotherapy.

resultsThe trial showed a prognostic effect of the genomic signature (adjusted hazard ratio 2.4). A decision-analytic modeling approach identified far fewer women as candidates for genetic testing (4% rather than 50%) and fewer benefiting from chemotherapy (3% rather than 27%) as compared with the MINDACT trial report. The selection of women benefitting from genetic testing and chemotherapy depended strongly on the required benefit from treatment and the assumed therapeutic effect of chemotherapy.

conclusionsA high-quality pragmatic trial was insufficient to directly inform clinical practice on the utility of a genomic test for individual women. The indication for genomic testing may be far more limited than suggested by the MINDACT trial.

Indexed as

Breast NeoplasmsChemotherapy, AdjuvantDecision MakingFemaleGenetic TestingHumansPrognosisbiomarker evaluationbreast cancerclinical utilitygenomic testingrisk stratification

Identifiers

PMID33655778
PMCPMC7985855
OpenAlexW3135216109

What OpenQuestion holds

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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.