Evidence mapPaperPMID 40924700Full record

ArticlePloS one2025

The SURVIVE study (NCT05658172): Bringing breast cancer aftercare to the 21stcentury: Study protocol of a Phase III clinical trial comparing liquid biopsy guided vs. Standard of care surveillance for intermediate to high-risk breast cancer survivors.

Tatjana Braun, Sophia Huesmann, Kerstin Pfister, Thomas W P Friedl, Andreas Hartkopf, Klaus Pantel, Forca Mehmeti, Franziska Mergel, Henning Schäffler, Sabine Heublein and 5 more

Abstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

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

1 citing paper in PubMed.

  1. 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

15 authors.

Tatjana BraunDepartment of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany.
Sophia HuesmannDepartment of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany.
Kerstin PfisterDepartment of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany.ORCID https://orcid.org/0009-0002-2831-1401
Thomas W P FriedlDepartment of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany.ORCID https://orcid.org/0000-0002-4773-8067
Andreas HartkopfInstitute of Women's Health, University Hospital Tübingen, Tübingen, Germany.
Klaus PantelCenter for Experimental Medicine, Institute of Tumor Biology, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
Forca MehmetiDepartment of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany.
Franziska MergelDepartment of Gynecology and Obstetrics, SLK-Kliniken Heilbronn, Heilbronn, Germany.
Henning SchäfflerDepartment of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany.
Sabine HeubleinDepartment of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany.
Lisa WiesmüllerDepartment of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany.
Brigitte RackDepartment of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany.
Peter A FaschingDepartment of Gynecology and Obstetrics, University Hospital Erlangen, Erlangen, Germany.
Wolfgang JanniDepartment of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany.
Angelina FinkDepartment of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany.ORCID https://orcid.org/0000-0002-9481-830X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCurrent aftercare in breast cancer survivors aims to detect local recurrences or contralateral disease, while the detection of distant metastases has not been a central focus due to a lack of evidence supporting an effect on overall survival. However, the data underpinning these guidelines are mainly from trials of the 1980s/1990s and have not been updated to reflect the significant advancements in diagnostic and therapeutic options that have emerged over the past 40 years. In this trial, the aim is to test whether a liquid biopsy-based detection of (oligo-) metastatic disease at an early pre-symptomatic stage followed by timely treatment can impact overall survival compared to current standard aftercare.

methodsIn this partially double-blinded superiority study, intensified liquid biopsy-guided surveillance will be assessed versus standard surveillance in medium-to-high-risk early breast cancer patients. Intensive surveillance comprises 3-monthly tests of circulating free tumor DNA (ctDNA), circulating tumor cells (CTC) and serum tumor markers CEA, CA 27.29 and CA125. Upon positivity of biomarker and/or symptoms, staging examinations are initiated. In total, 3500 patients will be randomized in a 1:1 ratio after completion of primary antineoplastic therapy. Co-primary endpoints are overall survival (OS) and the overall lead time effect. The trial will be accompanied by an extensive translational research program. DISCUSSION: A risk-based aftercare and regular screening for asymptomatic metastatic disease with molecular markers in the absence of any radiological findings can potentially revolutionize current follow-up care of breast cancer survivors and enable potential treatment even before patients suffer from symptomatic, incurable disease.

Indexed as

AftercareBreast NeoplasmsCancer SurvivorsAdultBiomarkers, TumorCirculating Tumor DNAClinical Trials, Phase III as TopicDouble-Blind MethodEquivalence Trials as TopicFemaleHumansLiquid BiopsyNeoplasm Recurrence, LocalNeoplastic Cells, CirculatingStandard of CareBiomarkers, TumorCirculating Tumor DNA

Identifiers

PMID40924700
PMCPMC12419582

What Socratic holds

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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 Socratic graph.