Evidence map›Paper›PMID 40100138›Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2025

Clinical Validity of Repeated Circulating Tumor Cell Enumeration as an Early Treatment Monitoring Tool for Metastatic Breast Cancer in the PREDICT Global Pooled Analysis.

Wolfgang Janni, Thomas W P Friedl, Tracy C Yab, Francois-Clément Bidard, Massimo Cristofanilli, Daniel F Hayes, Michail Ignatiadis, Meredith M Regan, Catherine Alix-Panabieres, William E Barlow and 33 more

Abstract read
In one paragraph

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing 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

12 citing papers in PubMed.

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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

43 authors.

Wolfgang Janni *Department of Obstetrics and Gynecology, University Hospital Ulm, Ulm, Germany.ORCID 0000-0001-5911-2400
Thomas W P Friedl *Department of Obstetrics and Gynecology, University Hospital Ulm, Ulm, Germany.ORCID 0000-0002-4773-8067
Tracy C YabDepartment of Oncology, Mayo Clinic, Rochester, Minnesota.ORCID 0000-0002-9116-8428
Francois-Clément BidardDepartment of Medical Oncology, Institute Curie, UVSQ University, Paris & St Cloud, France.ORCID 0000-0001-5932-8949
Massimo CristofanilliDivision of Hematology and Oncology, Department of Medicine, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois.ORCID 0000-0002-4194-7175
Daniel F HayesBreast Oncology Section, University of Michigan Rogel Cancer Center, Ann Arbor, Michigan.ORCID 0000-0003-3620-7575
Michail IgnatiadisDepartment of Medical Oncology, Institute Jules Bordet, Hôspital Universitaire de Bruxelles (H.U.B), Université Libre de Bruxelles, Brussels, Belgium.ORCID 0000-0002-4493-3748
Meredith M ReganDivision of Biostatistics, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts.ORCID 0000-0002-2428-6109
Catherine Alix-PanabieresLaboratory of Rare Human Circulating Cells (LCCRH), University Medical Centre of Montpellier, Montpellier, France.ORCID 0000-0002-6401-2903
William E BarlowSWOG Statistical Center, Seattle, Washington.ORCID 0000-0003-4651-2282
Carlos CaldasDepartment of Oncology, Cancer Research UK Cambridge Institute, University of Cambridge, Cambridge, United Kingdom.ORCID 0000-0003-3547-1489
Lisa A CareyLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina.ORCID 0000-0003-2388-4649
Luc DirixUniversity of Antwerp and GZA Sint-Augustinus, Antwerp, Belgium.ORCID 0000-0002-6248-1677
Tanja FehmDepartment of Gynecology and Obstetrics and CIO ABCD, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.ORCID 0000-0002-4926-0108
Jose A Garcia-SaenzDCIBERONC, IdISCC, Madrid, Spain.ORCID 0000-0001-6880-0301
Paola GazzanigaLiquid Biopsy Unit, Department of Molecular Medicine, Sapienza University of Rome, Rome, Italy.ORCID 0000-0002-2325-2273
Daniele GeneraliWomen Cancer Center, Azienda Socio Sanitaria Territoriale di Cremona, University of Trieste, Trieste, Italy.ORCID 0000-0003-2480-3855
Lorenzo GerratanaDepartment of Medical Oncology, CRO Aviano, National Cancer Institute, IRCCS, Aviano, Italy.ORCID 0000-0002-8313-4834
Rafael Gisbert-CriadoClinical Laboratory, Hospital Arnau de Vilanova, Valencia, Spain.ORCID 0000-0003-4845-3706
William JacotDepartment of Medical Oncology, Institut du Cancer de Montpellier (ICM), IRCM, INSERM U1194, Université de Montpellier, Montpellier, France.ORCID 0000-0001-7834-061X
Zefei JiangDepartment of Breast Cancer, The 307th Hospital of Chinese People's Liberation Army, Beijing, China.ORCID 0000-0002-4295-0173
Simon A JoosseDepartment of Tumor Biology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.ORCID 0000-0002-4296-5615
Evi LianidouLaboratory of Analytical Chemistry, Analysis of Circulating Tumor Cells (ACTC) Lab, Department of Chemistry, National and Kapodistrian University of Athens, Athens, Greece.ORCID 0000-0002-7796-5914
Rafael López LópezTranslational Medical Oncology Group, Oncomet, Health Research Institute of Santiago de Compostela (IDIS), Santiago de Compostela University Hospital (SERGAS), Santiago de Compostela, Spain.ORCID 0000-0003-1315-655X
Mark J M MagbanuaDepartment of Laboratory Medicine, University of California San Francisco, San Francisco, California.ORCID 0000-0003-2113-3593
Luis MansoDepartment of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain.ORCID 0000-0002-1683-550X
Dimitris MavroudisDepartment of Medical Oncology, University General Hospital of Heraklion, Iraklio, Greece.ORCID 0000-0003-0587-1713
Volkmar MüllerDepartment of Gynecology and Obstetrics, University Hospital Hamburg-Eppendorf, Hamburg, Germany.ORCID 0000-0003-4231-7906
Elisabetta MunzoneDivision of Medical Senology, European Institute of Oncology, IRCCS, Milan, Italy.ORCID 0000-0003-3371-3878
Klaus PantelDepartment of Tumor Biology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.ORCID 0000-0001-5736-2772
Jean-Yves PiergaDepartment of Medical Oncology, Institute Curie, Université Paris Cité, Paris & St Cloud, France.ORCID 0000-0002-2863-9995
Brigitte RackDepartment of Obstetrics and Gynecology, University Hospital Ulm, Ulm, Germany.ORCID 0000-0002-7539-4839
Sabine RiethdorfDepartment of Tumor Biology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.ORCID 0000-0003-0028-5643
Hope S RugoDepartment of Laboratory Medicine, University of California San Francisco, San Francisco, California.ORCID 0000-0001-6710-4814
Kostandinos SiderasHematology and Medical Oncology, Mayo Clinic, Jacksonville, Florida.ORCID 0000-0002-4698-2105
Stefan SleijferDepartment of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.ORCID 0000-0002-0446-9039
Jeffrey SmerageBreast Oncology Section, University of Michigan Rogel Cancer Center, Ann Arbor, Michigan.ORCID 0000-0001-9130-9342
Justin StebbingSchool of Life Sciences, Anglia Ruskin University, Cambridge, United Kingdom.ORCID 0000-0002-1117-6947
Leon W M M TerstappenMedical Cell BioPhysics Group, Faculty of Science and Technology, University of Twente, Enschede, the Netherlands.ORCID 0000-0001-5944-3787
Jose Vidal-MartínezClinical Laboratory, Hospital Arnau de Vilanova, Valencia, Spain.ORCID 0000-0002-5986-7966
Markus WallwienerDepartment of Obstetrics and Gynecology, Medical School, University of Heidelberg, Heidelberg, Germany.ORCID 0000-0002-4139-9340
Karthik V GiridharDepartment of Oncology, Mayo Clinic, Rochester, Minnesota.ORCID 0000-0003-4640-9197
Minetta C LiuDepartment of Oncology, Mayo Clinic, Rochester, Minnesota.ORCID 0000-0002-8206-5232

Funding

SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
UM LAPs -UG1 GrantUG1CA233160 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI ANNE F SCHOTT · 2019 to 2026
$5.4M
NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA233160
6 · The paper itself

Abstract

purposeThe aim of PREDICT was to confirm clinical validity and the potential for clinical utility of serial circulating tumor cell (CTC) enumeration in patients with metastatic breast cancer, focusing on its prognostic value in different breast cancer subtypes and clinical settings. EXPERIMENTAL

designIn total, 4,436 individual patient-level data with CTC results from both baseline and one follow-up (CellSearch; Menarini Silicon Biosystems) were analyzed to evaluate the association between CTC detection and overall survival (OS) in the full patient cohort and separately for tumor and treatment types.

resultsUsing the cutoff ≥1 CTC for CTC positivity, 913 (20.6%) patients had 0 CTCs at both time points (neg/neg) and 325 (7.3%) and 1,189 (26.8%) patients converted from CTC negative to CTC positive (neg/pos) or vice versa (pos/neg), whereas 2,009 (45.3%) patients had at least one CTC at both time points (pos/pos). The median OS for the neg/neg, neg/pos, pos/neg, and pos/pos group was 45.6, 26.1, 32.3, and 17.3 months, respectively (P < 0.0001, global log-rank test). CTC responders (pos/neg) showed a lower risk of death compared with CTC nonresponders (pos/pos; HR, 0.48; 95% confidence interval, 0.44-0.53). Similar results were obtained in subgroup analyses according to hormone receptor and HER2 subtype, treatment type, and with a ≥5 CTC cutoff for CTC positivity.

conclusionsFollow-up CTC assessments strongly predict OS independently from tumor subtype and treatment. New randomized trials to define the clinical utility of CTC monitoring for risk stratification and as an early response marker in metastatic breast cancer are urgently needed.

Indexed as

Breast NeoplasmsNeoplastic Cells, CirculatingAdultAgedAged, 80 and overBiomarkers, TumorFemaleHumansMiddle AgedNeoplasm MetastasisPrognosisBiomarkers, Tumor

Identifiers

PMID40100138
PMCPMC12130808

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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.