Evidence mapPaperPMID 39593191Full record

Trial reportBreast cancer research : BCR2024

Low-dose tamoxifen treatment reduces collagen organisation indicative of tissue stiffness in the normal breast: results from the KARISMA randomised controlled trial.

Sara Göransson, Pablo Hernández-Varas, Mattias Hammarström, Roxanna Hellgren, Magnus Bäcklund, Kristina Lång, Ann H Rosendahl, Mikael Eriksson, Signe Borgquist, Staffan Strömblad and 3 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Breast cancer research : BCR, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03346200 (A Randomised, Double Blinded, Six-armed Placebo Controlled Study to Investigate Optimal Dose of Tamoxifen With the Most Favourable Side Effect Spectre and With Mammography Density Reduction Non-inferior to That of 20 mg Tamoxifen), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
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.

NCT03346200 phase2completednot on this map

A Randomised, Double Blinded, Six-armed Placebo Controlled Study to Investigate Optimal Dose of Tamoxifen With the Most Favourable Side Effect Spectre and With Mammography Density Reduction Non-inferior to That of 20 mg Tamoxifen

TypeinterventionalSponsorPer HallRan2016 to 2019Enrolled1,440ConditionsRisk Reduction, Mammographic Density ReductionArmsTamoxifen Oral Tablet, Placebo Oral Tablet
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Review
  3. Fibrosis and cancer intersection.Journal of translational medicine · 2025
    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

13 authors.

Sara GöranssonDepartment of Biosciences and Nutrition, Karolinska Institutet, Huddinge, Sweden.
Pablo Hernández-VarasCore Facility for Integrated Microscopy, Department of Biomedical Sciences, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.
Mattias HammarströmDepartment of Medical Epidemiology and Biostatistics, Karolinska Institutet, Nobels väg 12A, 171 77, Solna, Sweden.
Roxanna HellgrenDepartment of Breast Imaging, Södersjukhuset, Stockholm, Sweden.
Magnus BäcklundDepartment of Medical Epidemiology and Biostatistics, Karolinska Institutet, Nobels väg 12A, 171 77, Solna, Sweden.
Kristina LångDepartment of Translational Medicine, Diagnostic Radiology, Lund University, Lund, Sweden.
Ann H RosendahlDepartment of Clinical Sciences Lund, Oncology, Lund University and Skåne University Hospital, Lund, Sweden.
Mikael ErikssonDepartment of Medical Epidemiology and Biostatistics, Karolinska Institutet, Nobels väg 12A, 171 77, Solna, Sweden.
Signe BorgquistDepartment of Oncology, Aarhus University Hospital, Aarhus University, Aarhus, Denmark.
Staffan StrömbladDepartment of Biosciences and Nutrition, Karolinska Institutet, Huddinge, Sweden.
Kamila CzeneDepartment of Medical Epidemiology and Biostatistics, Karolinska Institutet, Nobels väg 12A, 171 77, Solna, Sweden.
Per HallDepartment of Medical Epidemiology and Biostatistics, Karolinska Institutet, Nobels väg 12A, 171 77, Solna, Sweden.
Marike GabrielsonDepartment of Medical Epidemiology and Biostatistics, Karolinska Institutet, Nobels väg 12A, 171 77, Solna, Sweden. Marike.gabrielson@ki.se.

Funding

Cancerfonden 23 2856 PjCancerfonden CAN 2015/649Cancerfonden CAN 21-0454 FEFamiljen Kamprads Stiftelse 20150052Radiumhemmets Forskningsfonder 201353Stockholm läns landsting 4-2645/2015Vetenskapsrådet 2021-01139Vetenskapsrådet E0718301
6 · The paper itself

Abstract

backgroundTissue stiffness, dictated by organisation of interstitial fibrillar collagens, increases breast cancer risk and contributes to cancer progression. Tamoxifen is a standard treatment for receptor-positive breast cancer and is also aproved for primary prevention. We investigated the effect of tamoxifen and its main metabolites on the breast tissue collagen organisation as a proxy for stiffness and explored the relationship between mammographic density (MD) and collagen organisation. MATERIAL AND

methodsThis sub-study of the double-blinded dose-determination trial, KARISMA, included 83 healthy women randomised to 6 months of 20, 10, 5, 2.5, and 1 mg of tamoxifen or placebo. Ultrasound-guided core-needle breast biopsies collected before and after treatment were evaluated for collagen organisation by polarised light microscopy.

resultsTamoxifen reduced the amount of organised collagen and overall organisation, reflected by a shift from heavily crosslinked thick fibres to thinner, less crosslinked fibres. Collagen remodelling correlated with plasma concentrations of tamoxifen metabolites. MD change was not associated with changes in amount of organised collagen but was correlated with less crosslinking in premenopausal women.

conclusionsIn this study of healthy women, tamoxifen decreased the overall organisation of fibrillar collagens, and consequently, the breast tissue stiffness. These stromal alterations may play a role in the well-established preventive and therapeutic effects of tamoxifen. Trial registration ClinicalTrials.gov ID: NCT03346200. Registered November 1st, 2017. Retrospectively registered.

Indexed as

Antineoplastic Agents, HormonalBreast DensityCollagenTamoxifenAdultBreastBreast NeoplasmsDouble-Blind MethodFemaleHumansMiddle AgedAntineoplastic Agents, HormonalCollagenTamoxifen

Identifiers

PMID39593191
PMCPMC11590516

What Socratic holds

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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.