Evidence map›Paper›PMID 40441802›Full record

Trial reportESMO open2025

Patient-reported outcomes with trastuzumab deruxtecan in hormone receptor-positive, HER2-low or HER2-ultralow metastatic breast cancer: results from the randomized DESTINY-Breast06 trial.

X Hu, G Curigliano, K Yonemori, A Bardia, C H Barrios, J Sohn, C Lévy, W Jacot, J Tsurutani, A Roborel de Climens and 4 more

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

Trial report in ESMO open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04494425 (A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

NCT04494425 phase3active not recruitingnot on this map

A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY-Breast06)

TypeinterventionalSponsorAstraZenecaRan2020 to 2026Enrolled866ConditionsAdvanced or Metastatic Breast CancerArmsTrastuzumab deruxtecan, Capecitabine, Paclitaxel, Nab-Paclitaxel
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Review
  2. Review
  3. Targeted therapies in pediatric oncology: A start.Molecular therapy. Oncology · 2026
    Review
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
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

14 authors.

X HuDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. Electronic address: xchu2009@hotmail.com.
G CuriglianoDivision of Early Drug Development for Innovative Therapies, European Institute of Oncology, IRCCS, Milano, Italy; Department of Oncology and Hematology-Oncology, University of Milano, Milano, Italy.
K YonemoriDepartment of Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
A BardiaDivision of Hematology/Oncology, University of California Los Angeles, Jonsson Comprehensive Cancer Center, Los Angeles, USA.
C H BarriosLatin American Cooperative Oncology Group (LACOG), Porto Alegre, Brazil.
J SohnDivision of Medical Oncology, Yonsei Cancer Center, Seoul, Republic of Korea.
C LévyDepartment of Medical Oncology, Centre François Baclesse, Caen, France.
W JacotDepartment of Medical Oncology, Institut du Cancer de Montpellier, Université de Montpellier, INSERM U1194, Montpellier, France.
J TsurutaniThe Innovative Center of Translational Research and Clinical Science for Cancer Therapy, Showa University Hospital, Tokyo, Japan.
A Roborel de ClimensPatient-Centered Solutions, IQVIA, Paris, France.
X WuOncology Biometrics, Oncology R&D, AstraZeneca, Gaithersburg, USA.
A Andrzejuk-ĆwikClinical Development, Late-Stage Development, Oncology R&D, AstraZeneca, Warsaw, Poland.
Z MbanyaGlobal Health Economics & Payer Evidence, AstraZeneca, Cambridge, UK.
R DentDivision of Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe randomized phase III DESTINY-Breast06 trial (NCT04494425) demonstrated superior efficacy with trastuzumab deruxtecan (T-DXd) versus chemotherapy treatment of physician's choice (TPC) and no new safety signals in patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-low [immunohistochemistry (IHC) 1+, IHC 2+/in situ hybridization-negative], and HER2-ultralow (IHC 0 with membrane staining) metastatic breast cancer (mBC). Here, we report the patient-reported outcome (PRO) endpoints in the intent-to-treat (ITT; HER2-low/-ultralow) and HER2-low populations. PATIENTS AND

methodsPatients with progressive disease (PD) after one or more prior lines of endocrine-based therapy and no prior chemotherapy for mBC were assigned 1 : 1 to T-DXd 5.4 mg/kg once every 3 weeks (n = 436) or TPC [n = 430; 59.8% capecitabine; 24.4% nab-paclitaxel; and 15.8% paclitaxel]. PRO questionnaires included the European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and breast cancer-specific module (EORTC QLQ-BR45). Changes from baseline (CFB; earliest of 31 weeks or on-study PD) and time to deterioration were assessed.

resultsThe median treatment duration was 11.0 (T-DXd) versus 5.6 (TPC) months. In the ITT, the mean CFB scores were similar across treatments in EORTC QLQ-C30 global health status/quality of life (QOL) and functioning scales. T-DXd was associated with less pain [adjusted mean difference -7.2, 95% confidence interval (CI) -9.9 to -4.5] and fewer skin/mucosal symptoms (adjusted mean difference -9.5, 95% CI -11.5 to -7.5), but more nausea/vomiting (adjusted mean difference 7.2, 95% CI 5.3-9.2), appetite loss (adjusted mean difference 6.8, 95% CI 3.6-10.0), and constipation (adjusted mean difference 5.5, 95% CI 2.6-8.4) versus TPC. T-DXd reduced the risk of clinically meaningful deterioration in physical/role/emotional functioning, pain, and fatigue versus TPC, but increased the risk of deterioration in gastrointestinal symptoms. Results were similar in the HER2-low population.

conclusionsT-DXd preserved QOL while delaying deterioration in physical/role/emotional functioning, pain, and fatigue versus TPC, albeit with more gastrointestinal symptoms. PRO data complement the efficacy/safety of T-DXd in this population.

Indexed as

Antineoplastic Agents, ImmunologicalBreast NeoplasmsErb-b2 Receptor Tyrosine KinasesImmunoconjugatesPatient Reported Outcome MeasuresTrastuzumabAdultAgedCamptothecinFemaleHumansMiddle AgedNeoplasm MetastasisQuality of LifeAntineoplastic Agents, ImmunologicalCamptothecinERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesImmunoconjugatesTrastuzumabtrastuzumab deruxtecanHER2-lowmetastatic breast cancerpatient-reported outcomesquality of lifetrastuzumab deruxtecan

Identifiers

PMID40441802
PMCPMC12167881

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.