Evidence map›Paper›PMID 42372579›Full record

SynthesisBreast (Edinburgh, Scotland)2026

Tucatinib in patients with HER2-positive advanced/metastatic breast cancer: A systematic literature review of real-world evidence.

Rodrigo Sanchez-Bayona, Carey Anders, Rupert Bartsch, David A Cameron, Eva M Ciruelos, Carmen Criscitiello, Francois P Duhoux, Theodoros Foukakis, Jean-Sebastien Frenel, Joseph Gligorov and 13 more

Abstract readSystematic Review
In one paragraph

Synthesis in Breast (Edinburgh, Scotland), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

23 authors.

Rodrigo Sanchez-BayonaHospital Universitario 12 de Octubre. Instituto de Investigacion Sanitaria Hospital 12 de Octubre (imas12), Madrid, Spain. Electronic address: rodrigo.sanchez@gruposolti.org.
Carey AndersDuke Center Institute, Durham, NC, USA.
Rupert BartschDivision of Oncology, Department of Medicine 1, Medical University of Vienna, Vienna, Austria.
David A CameronInstitute of Genetics and Cancer, University of of Edinburgh, Edinburgh, UK.
Eva M CiruelosHospital Universitario 12 de Octubre, Instituto de Investigación Sanitaria 12 de Octubre, Madrid, Spain; HM CIOCC, Madrid, Spain.
Carmen CriscitielloDepartment of Oncology and Haemato-Oncology, University of Milan, Milan, Italy; European Institute of Oncology IRCCS, Milan, Italy.
Francois P DuhouxCliniques Universitaires Saint-Luc, Brussels, Belgium.
Theodoros FoukakisDepartment of Oncology-Pathology, Karolinska Institute, Stockholm, Sweden; Karolinska Comprehensive Cancer Centre and University Hospital, Stockholm, Sweden.
Jean-Sebastien FrenelDepartment of Medical Oncology, Institut de Cancerologie de l'Ouest, Saint-Herblain, France.
Joseph GligorovInstitut Universitaire de Cancérologie AP-HP Sorbonne Université, Paris, France.
Peter A KaufmanUniversity of Vermont Cancer Center, Burlington, VT, USA.
Matteo LambertiniDepartment of Internal Medicine and Medical Specialties (DIMI), School of Medicine, University of Genova, Genoa, Italy; Academic Medical Oncology Unit, Ente Ospedaliero Ospedali Galliera, Genoa, Italy.
Nathalie LeVasseurBC Cancer - Vancouver, Vancouver, BC, Canada.
Alicia OkinesThe Royal Marsden Hospital, London, UK; The Institute of Cancer Research, London, UK.
Frédérique Penault-LlorcaCentre Jean Perrin, Université Clermont Auvergne, INSERM, Imagerie Moléculaire et Stratégies Théranostiques, Clermont-Ferrand, France.
Volkmar MüllerUniversity Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Matthew T BlahnaPfizer Inc, Bothell, WA, USA.
Edward NeubergerPfizer Inc, San Francisco, CA, USA.
Sofia SimonPfizer S.L.U., Madrid, Spain.
Emanuele ZanuccoPfizer Deutschland GmbH, Berlin, Germany.
Christian RoséPfizer Deutschland GmbH, Berlin, Germany.
Giuseppe CuriglianoDepartment of Oncology and Haemato-Oncology, University of Milan, Milan, Italy; European Institute of Oncology IRCCS, Milan, Italy.
Nadia HarbeckBreast Center, Department of Obstetrics and Gynecology and CCC Munich, LMU University Hospital, Munich, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRecent years have seen rapid advances in human epidermal growth factor receptor 2 (HER2)-directed therapies for breast cancer. The shifting therapeutic landscape has presented patients and clinicians with a plethora of effective treatment options, but optimal treatment sequencing can be challenging. Tucatinib is a HER2-selective tyrosine kinase inhibitor that, when given in combination with trastuzumab and capecitabine, has demonstrated survival benefits for patients with HER2-positive (HER2+) metastatic breast cancer (MBC) pretreated with trastuzumab, pertuzumab, and trastuzumab-emtansine. Real-world data, which can supplement knowledge gained from clinical trials, has begun to emerge for tucatinib, but a comprehensive review of these studies has yet to be conducted.

methodsA systematic literature review was conducted to identify studies published between January 2020 and January 2025 that evaluated the effectiveness and safety of tucatinib in routine clinical practice. Studies were eligible for inclusion if they utilized real-world data, involved patients with HER2+ MBC treated with tucatinib in any line of metastatic therapy, and assessed tucatinib's effectiveness, health-related quality of life (QoL), patient-reported outcomes (PROs), or safety.

resultsOf 468 unique references identified, 12 publications met the inclusion criteria, 3 of which were manuscripts and 9 of which were congress abstracts. Included studies were heterogeneous in sample size, the lines of therapy assessed, and outcomes reported. Tucatinib-based treatment outcomes in the post-trastuzumab deruxtecan (T-DXd) setting and for patients with brain metastases were also reported. Despite variability among studies, outcomes were broadly consistent with clinical trial findings.

conclusionOverall, the available real-world evidence supports the clinical effectiveness of tucatinib-based therapies in HER2+ MBC, including heavily pretreated populations, patients with prior exposure to T-DXd, and those with brain metastases. However, gaps remain in the real-world data regarding the safety profile of tucatinib and its impact on health-related quality of life in routine clinical practice.

Indexed as

Antineoplastic AgentsBreast NeoplasmsErb-b2 Receptor Tyrosine KinasesOxazolesPyridinesQuinazolinesAntineoplastic Combined Chemotherapy ProtocolsCapecitabineFemaleHumansQuality of LifeTrastuzumabAntineoplastic AgentsCapecitabineERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesOxazolesPyridinesQuinazolinesTrastuzumabtucatinibAdvanced/metastatic breast cancerHER2-PositivePost T-DXdReal-world evidenceTargeted therapyTucatinib

Identifiers

PMID42372579
PMCPMC13333369

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.