Evidence map›Paper›PMID 40349139›Full record

Trial reportThe oncologist2025

Patient-reported outcomes from DESTINY-Breast04: trastuzumab deruxtecan versus physician's choice of chemotherapy in patients with HER2-low mBC.

Naoto T Ueno, Francesco Cottone, Kyle Dunton, William Jacot, Toshinari Yamashita, Joohyuk Sohn, Eriko Tokunaga, Aleix Prat, Junji Tsurutani, Yeon Hee Park and 10 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in The oncologist, 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 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.

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

12 citing papers in PubMed.

  1. Trial
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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

20 authors.

Naoto T UenoTranslational and Clinical Research Program, University of Hawai'i Cancer Center, Honolulu, HI, 96813, United States.ORCID 0000-0002-0166-7275
Francesco CottoneGlobal Oncology HEOR and RWE, Daiichi Sankyo, Rome, 00142, Italy.
Kyle DuntonGlobal Oncology HEOR and RWE, Daiichi Sankyo, Uxbridge, UB8 1DH, United Kingdom.
William JacotDepartment of Medical Oncology, Institut du Cancer de Montpellier, Montpellier University, INSERM U1194, Montpellier, 34298, France.ORCID 0000-0001-7834-061X
Toshinari YamashitaDepartment of Breast Surgery and Oncology, Kanagawa Cancer Center, Yokohama, 241-8515, Japan.ORCID 0000-0002-6479-1660
Joohyuk SohnDepartment of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, 03722, Republic of Korea.ORCID 0000-0002-2303-2764
Eriko TokunagaDepartment of Translational Genomics and Targeted Therapies Group, National Hospital Organization (NHO) Kyushu Cancer Center, Fukuoka, 811-1395, Japan.
Aleix PratDepartment of Medical Oncology, Hospital Clínic de Barcelona, Barcelona, 08036, Spain.ORCID 0000-0003-2377-540X
Junji TsurutaniAdvanced Cancer Translational Research Institute, Showa University, Tokyo, 142-8555, Japan.ORCID 0000-0002-6260-6943
Yeon Hee ParkDepartment of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 06351, Republic of Korea.
Hope S RugoDepartment of Medicine, Hellen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA, 94115, United States.
Binghe XuDepartment of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
Fatima CardosoBreast Unit, Champalimaud Clinical Center/Champalimaud Foundation and ABC Global Alliance, Lisbon, 1400-038, Portugal.ORCID 0000-0002-6692-2249
Zahi MitriDepartment of Hematology/Oncology, Oregon Health & Science University, Portland, OR 97239,, United States.
Reshma MahtaniDepartment of Hematology/Oncology, Miami Cancer Institute, Baptist Health South Florida, Miami, FL, 33324, United States.
Cecilia Orbegoso AguilarDepartment of Oncology Research and Development, Daiichi Sankyo France SAS, Rueil-Malmaison, 92500, France.
Feng XiaoBiostatistics and Data Management, Daiichi Sankyo, Inc., Basking Ridge, NJ, 07920, United States.
Nadia HarbeckBreast Center, Department of Obstetrics and Gynecology, and CCC Munich, LMU University Hospital, Munich, 81377, Germany.ORCID 0000-0002-9744-7372
David A CameronEdinburgh University Cancer Centre, Institute of Genetics and Cancer, University of Edinburgh, Edinburgh, EH4 2XR, United Kingdom.
Shanu ModiDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, 10065, United States.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
AstraZeneca.Daiichi Sankyo, IncNCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundThe phase 3 DESTINY-Breast04 trial demonstrated superior efficacy and acceptable safety with trastuzumab deruxtecan (T-DXd) vs physician's choice of chemotherapy in previously treated patients with human epidermal growth factor receptor 2 (HER2)-low metastatic breast cancer (mBC). We report the patient-reported outcomes (PROs), focusing on the hormone receptor-positive cohort. PATIENTS AND

methodsPatients were randomized 2:1 to T-DXd (5.4 mg/kg intravenously every 3 weeks) or physician's choice of chemotherapy and prospectively assessed for PRO measures. Change from baseline and time to definitive deterioration (TDD) were calculated from the EORTC QLQ-C30 and QLQ-BR45 and the EQ-5D-5L questionnaires.

resultsBaseline global health status/quality of life (GHS/QoL) scores were similar between groups (T-DXd, 331 patients; physician's choice, 163 patients); there were no clinically meaningful changes while on either treatment (median duration: T-DXd, 8.2 months; physician's choice, 3.5 months). Median TDD for GHS/QoL was delayed with T-DXd vs physician's choice (11.4 vs 7.5 months, respectively; hazard ratio, 0.69; 95% CI, 0.52-0.92). Median TDD for all prespecified PROs, including pain, favored T-DXd. In an additional analysis, the median TDD was shorter for nausea and vomiting with T-DXd vs the physician's choice.

conclusionsTrastuzumab deruxtecan maintained GHS/QoL scores despite a longer treatment course compared with standard chemotherapy and delayed definitive deterioration across all prespecified PROs vs the physician's choice. Appropriate management of adverse events and use of preventive measures (ie, antiemetic prophylaxis) may further support patient health-related quality of life. These findings reinforce the benefit of T-DXd as an option for patients with HER2-low mBC. ClinicalTrials.gov: NCT03734029.

Indexed as

Breast NeoplasmsCamptothecinErb-b2 Receptor Tyrosine KinasesImmunoconjugatesTrastuzumabAdultAgedAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansMiddle AgedPatient Reported Outcome MeasuresQuality of LifeCamptothecinERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesImmunoconjugatesTrastuzumabtrastuzumab deruxtecanantibody-drug conjugateHER2-lowmetastatic breast cancerpatient-reported outcomesquality of lifetrastuzumab deruxtecan

Identifiers

PMID40349139
PMCPMC12065936

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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.