Evidence map›Paper›PMID 41062831›Full record

Trial reportNature medicine2025

Trastuzumab deruxtecan in HER2-low metastatic breast cancer: long-term survival analysis of the randomized, phase 3 DESTINY-Breast04 trial.

Shanu Modi, William Jacot, Hiroji Iwata, Yeon Hee Park, Maria Vidal Losada, Wei Li, Junji Tsurutani, Naoto T Ueno, Khalil Zaman, Aleix Prat and 15 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Nature medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03734029 (A Phase 3, Multicenter, Randomized, Open-label, Active Controlled Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate), which is not on this map. Cited by 38 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 3 pooled it
–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.

NCT03734029 phase3active not recruitingnot on this map

A Phase 3, Multicenter, Randomized, Open-label, Active Controlled Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects

TypeinterventionalSponsorDaiichi SankyoRan2018 to 2026Enrolled557ConditionsBreast CancerArmsTrastuzumab deruxtecan (DS-8201a), Capecitabine, Eribulin, Gemcitabine, Paclitaxel
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Durvalumab plus Paclitaxel, with or without Capivasertib or Oleclumab, in Patients with Locally Advanced/Metastatic Triple-Negative Breast Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Trial
  5. Article
  6. Review
  7. Review
  8. The immunology of human breast cancer.Nature reviews. Immunology · 2026
    Review
  9. Review
  10. Article
  11. Article
  12. Review
  13. Article
  14. European journal of nuclear medicine and molecular imaging · 2026
    Article
  15. Review
  16. Review
  17. Review
  18. Article
  19. Review
  20. 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

25 authors.

Shanu ModiDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA. modis@mskcc.org.ORCID http://orcid.org/0000-0001-6427-7373
William JacotMedical Oncology Department, Institut du Cancer de Montpellier, Université de Montpellier, INSERM U1194, Montpellier, France.ORCID http://orcid.org/0000-0001-7834-061X
Hiroji IwataNagoya City University, Nagoya, Japan.
Yeon Hee ParkSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Maria Vidal LosadaDepartment of Medical Oncology, Hospital Clinic of Barcelona, Translational Genomics and Targeted Therapies in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain.ORCID http://orcid.org/0000-0003-1992-5727
Wei LiFirst Hospital of Jilin University, Changchun, China.
Junji TsurutaniAdvanced Cancer Translational Research Institute, Showa University, Tokyo, Japan.ORCID http://orcid.org/0000-0002-6260-6943
Naoto T UenoTranslational and Clinical Research Program, University of Hawai'i Cancer Center, Honolulu, HI, USA.ORCID http://orcid.org/0000-0002-0166-7275
Khalil ZamanDepartment of Oncology, Lausanne University Hospital CHUV, Lausanne, Switzerland.ORCID http://orcid.org/0000-0002-2997-527X
Aleix PratClinic Barcelona Comprehensive Cancer Center, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain.ORCID http://orcid.org/0000-0003-2377-540X
Konstantinos PapazisisEuromedica General Clinic, Thessaloniki, Greece.
Hope S RugoDepartment of Medicine, UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA.ORCID http://orcid.org/0000-0001-6710-4814
Toshinari YamashitaDepartment of Breast Surgery and Oncology, Kanagawa Cancer Center, Yokohama, Japan.
Nadia HarbeckBreast Center, Department of Obstetrics and Gynecology and CCC Munich, LMU University Hospital, Munich, Germany.ORCID http://orcid.org/0000-0002-9744-7372
Seock-Ah ImSeoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0002-5396-6533
Michelino De LaurentiisDepartment of Breast and Thoracic Oncology, Istituto Nazionale Tumori IRCCS 'Fondazione G. Pascale', Naples, Italy.ORCID http://orcid.org/0000-0001-9009-1572
Jean-Yves PiergaDepartment of Medical Oncology, Institut Curie, Paris and Université Paris Cité, Paris, France.
Xiaojia WangZhejiang Cancer Hospital, Hangzhou, China.ORCID http://orcid.org/0000-0002-7005-0842
Andrea GombosMedical Oncology Department, Institut Jules Bordet, Brussels, Belgium.
Eriko TokunagaDepartment of Breast Oncology, NHO Kyushu Cancer Center, Fukuoka, Japan.
Cecilia Orbegoso AguilarGlobal Oncology R&D, Daiichi Sankyo France SAS, Rueil-Malmaison, France.
Lotus YungClinical Development, Daiichi Sankyo Inc., Basking Ridge, NJ, USA.
Feng XiaoBiostatistics, Daiichi Sankyo, Inc., Basking Ridge, NJ, USA.
Yingkai ChengClinical Safety and Pharmacovigilance, Daiichi Sankyo Inc., Basking Ridge, NJ, USA.
David CameronEdinburgh University Cancer Centre, University of Edinburgh, Edinburgh, UK.ORCID http://orcid.org/0000-0002-2717-7979

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Elisa de Stanchina · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

In DESTINY-Breast04 ( NCT03734029 ), trastuzumab deruxtecan (T-DXd) significantly improved overall survival (OS) and progression-free survival compared with treatment of physician's choice of chemotherapy (TPC) for patients with human epidermal growth factor receptor 2-low (HER2-low) (immunohistochemistry (IHC) 1+ or IHC 2+/in situ hybridization-negative) metastatic breast cancer. After an extended median follow-up of 32.0 months, median OS in the overall cohort was 22.9 months for T-DXd and 16.8 months for TPC (hazard ratio 0.69; 95% confidence interval 0.55-0.86). For the hormone receptor-positive cohort, median OS was 23.9 and 17.6 months for T-DXd and TPC, respectively (hazard ratio 0.69; 95% confidence interval 0.55-0.87). Median OS also favored T-DXd in exploratory analyses of hormone receptor-negative, estrogen receptor IHC 1%-10% and estrogen receptor IHC >10% cohorts. The overall safety profile of T-DXd was acceptable and generally manageable. Results confirm T-DXd as standard of care after prior chemotherapy in patients with HER2-low metastatic breast cancer. ClinicalTrials.gov identifier: NCT03734029 .

Indexed as

Breast NeoplasmsErb-b2 Receptor Tyrosine KinasesImmunoconjugatesTrastuzumabAdultAgedCamptothecinFemaleHumansMiddle AgedNeoplasm MetastasisSurvival AnalysisCamptothecinERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesImmunoconjugatesTrastuzumabtrastuzumab deruxtecan

Identifiers

PMID41062831
PMCPMC12705423

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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.