Evidence map›Paper›PMID 37488289›Full record

Trial reportNature medicine2023

Trastuzumab deruxtecan in metastatic breast cancer with variable HER2 expression: the phase 2 DAISY trial.

Fernanda Mosele, Elise Deluche, Amelie Lusque, Loïc Le Bescond, Thomas Filleron, Yoann Pradat, Agnes Ducoulombier, Barbara Pistilli, Thomas Bachelot, Frederic Viret and 25 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Nature medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04132960 (Phase II, Open Label Study of DS-8201a, an Anti-HER2-antibody Drug Conjugate), which is not on this map. Cited by 261 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
261citing papers in PubMed, 2 pooled it
75.5field-weighted citation impact, top 1% 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.

NCT04132960 phase2completednot on this map

Phase II, Open Label Study of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC) for Advanced Breast Cancer Patients, With Biomarkers Analysis to Characterize Response/Resistance to Therapy

TypeinterventionalSponsorUNICANCERRan2019 to 2024Enrolled186ConditionsBreast TumorsArmsDS-8201a
3 · Its place in the literature

Who cites it

261 citing papers in PubMed, 2 syntheses or guidelines pooled it, 327 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Computationally Derived Spatial Immune Signature Identifies Trastuzumab Responders in HER2+ Breast Cancer: NSABP B-41 Clinical Trial Validation.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Trial
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  8. Patritumab deruxtecan in HRNature medicine · 2025
    Trial
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  10. Targetable S100-RAGE Signaling Mediates Intrinsic Trastuzumab Deruxtecan Resistance in Metastatic Breast Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Article
  11. A modular framework for antibody-drug conjugate biomarkers.Nature reviews. Clinical oncology · 2026
    Review
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  15. Article
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201 more citing papers are in PubMed but not listed here.

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

35 authors at 13 institutions in 2 countries.

Fernanda MoseleINSERM U981, Gustave Roussy, Villejuif, France.ORCID http://orcid.org/0000-0001-7841-2900
Elise Deluche *Department of Medical Oncology, CHU Dupuytren, Limoges, France.ORCID http://orcid.org/0000-0001-8474-3116
Amelie Lusque *Department of Biostatistics, Institut Claudius-Regaud, IUCT Oncopole, Toulouse, France.
Loïc Le Bescond *INSERM U981, Gustave Roussy, Villejuif, France.
Thomas FilleronDepartment of Biostatistics, Institut Claudius-Regaud, IUCT Oncopole, Toulouse, France.
Yoann PradatMICS Lab, CentraleSupélec, Université Paris-Saclay, Gif-Sur-Yvette, France.ORCID http://orcid.org/0000-0002-4647-5779
Agnes DucoulombierDepartment of Medical Oncology, Centre Antoine Lacassagne, Nice, France.
Barbara PistilliDepartment of Medical Oncology, Gustave Roussy, Villejuif, France.ORCID http://orcid.org/0000-0002-9184-7199
Thomas BachelotDepartment of Medical Oncology, Centre Léon Bérard, Lyon, France.ORCID http://orcid.org/0000-0002-0866-9484
Frederic ViretDepartment of Medical Oncology, Centre Paoli Calmettes, Marseille, France.
Christelle LevyDepartment of Medical Oncology, Centre François Baclesse, Caen, France.
Nicolas SignolleAMMICa Platform, INSERM US23, CNRS UAR 3655, AMMICa, Villejuif, France.
Alexia AlfaroImaging and Cytometry Platform, Gustave Roussy, UAR 23/3655, Université Paris-Saclay, Villejuif, France.
Diep T N TranINSERM U981, Gustave Roussy, Villejuif, France.ORCID http://orcid.org/0000-0002-3982-4221
Ingrid Judith GarberisDepartment of Medical Biology and Pathology, Gustave Roussy, Villejuif, France.ORCID http://orcid.org/0000-0002-0501-8520
Hugues TalbotCVN Lab, CentraleSupélec,Université Paris-Saclay, Gif-Sur-Yvette, France.
Stergios ChristodoulidisMICS Lab, CentraleSupélec, Université Paris-Saclay, Gif-Sur-Yvette, France.ORCID http://orcid.org/0000-0002-8773-1070
Maria VakalopoulouOPIS, Inria, CentraleSupélec, Université Paris-Saclay, Gif-Sur-Yvette, France.
Nathalie DroinAMMICa Platform, INSERM US23, CNRS UAR 3655, AMMICa, Villejuif, France.ORCID http://orcid.org/0000-0002-6099-5324
Aurelie StourmAMMICa Platform, INSERM US23, CNRS UAR 3655, AMMICa, Villejuif, France.
Maki KobayashiTranslational Research Department, Daiichi Sankyo RD Novare, Tokyo, Japan.ORCID http://orcid.org/0000-0001-5920-5906
Tomoya KakegawaTranslational Research Department, Daiichi Sankyo RD Novare, Tokyo, Japan.
Ludovic LacroixAMMICa Platform, INSERM US23, CNRS UAR 3655, AMMICa, Villejuif, France.
Patrick SaulnierAMMICa Platform, INSERM US23, CNRS UAR 3655, AMMICa, Villejuif, France.
Bastien JobAMMICa Platform, INSERM US23, CNRS UAR 3655, AMMICa, Villejuif, France.
Marc DelogerAMMICa Platform, INSERM US23, CNRS UAR 3655, AMMICa, Villejuif, France.ORCID http://orcid.org/0000-0002-6352-101X
Marta JimenezR&D Department, Unicancer, Paris, France.ORCID http://orcid.org/0000-0002-4233-8478
Celine MahierR&D Department, Unicancer, Paris, France.ORCID http://orcid.org/0000-0001-8368-3174
Vianney BarisUMR9019, CNRS, Gustave Roussy, Université Paris-Saclay, Villejuif, France.ORCID http://orcid.org/0009-0001-8162-5920
Pierre LaplanteUMR9019, CNRS, Gustave Roussy, Université Paris-Saclay, Villejuif, France.
Patricia KannoucheUMR9019, CNRS, Gustave Roussy, Université Paris-Saclay, Villejuif, France.ORCID http://orcid.org/0000-0002-6050-3457
Virginie MartyAMMICa Platform, INSERM US23, CNRS UAR 3655, AMMICa, Villejuif, France.ORCID http://orcid.org/0000-0002-9122-9438
Magali Lacroix-Triki *Department of Medical Biology and Pathology, Gustave Roussy, Villejuif, France.ORCID http://orcid.org/0000-0002-6641-8536
Veronique Diéras *Department of Medical Oncology, Centre Eugène Marquis, Rennes, France.ORCID http://orcid.org/0000-0001-8094-4738
Fabrice André *INSERM U981, Gustave Roussy, Villejuif, France. fabrice.andre@gustaveroussy.fr.ORCID http://orcid.org/0000-0001-5795-8357
Centre National de la Recherche Scientifique · FRUniversité Paris-Saclay · FRInserm · FRInstitut Gustave Roussy · FRDaiichi-Sankyo (Japan) · JPInstitut Claudius Regaud · FRUniCancer Group · FRCentre Antoine Lacassagne · FRCentre Eugène Marquis · FRCentre François Baclesse · FRCentre Léon Bérard · FRHôpital Dupuytren · FRInstitut Pprime · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The mechanisms of action of and resistance to trastuzumab deruxtecan (T-DXd), an anti-HER2-drug conjugate for breast cancer treatment, remain unclear. The phase 2 DAISY trial evaluated the efficacy of T-DXd in patients with HER2-overexpressing (n = 72, cohort 1), HER2-low (n = 74, cohort 2) and HER2 non-expressing (n = 40, cohort 3) metastatic breast cancer. In the full analysis set population (n = 177), the confirmed objective response rate (primary endpoint) was 70.6% (95% confidence interval (CI) 58.3-81) in cohort 1, 37.5% (95% CI 26.4-49.7) in cohort 2 and 29.7% (95% CI 15.9-47) in cohort 3. The primary endpoint was met in cohorts 1 and 2. Secondary endpoints included safety. No new safety signals were observed. During treatment, HER2-expressing tumors (n = 4) presented strong T-DXd staining. Conversely, HER2 immunohistochemistry 0 samples (n = 3) presented no or very few T-DXd staining (Pearson correlation coefficient r = 0.75, P = 0.053). Among patients with HER2 immunohistochemistry 0 metastatic breast cancer, 5 of 14 (35.7%, 95% CI 12.8-64.9) with ERBB2 expression below the median presented a confirmed objective response as compared to 3 of 10 (30%, 95% CI 6.7-65.2) with ERBB2 expression above the median. Although HER2 expression is a determinant of T-DXd efficacy, our study suggests that additional mechanisms may also be involved. (ClinicalTrials.gov identifier NCT04132960 .).

Indexed as

Breast NeoplasmsImmunoconjugatesCamptothecinErb-b2 Receptor Tyrosine KinasesFemaleHumansTrastuzumabCamptothecinErb-b2 Receptor Tyrosine KinasesImmunoconjugatesTrastuzumabtrastuzumab deruxtecan

Identifiers

PMID37488289
PMCPMC10427426
OpenAlexW4385212704

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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 OpenQuestion graph.