Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023
Patritumab Deruxtecan (HER3-DXd), a Human Epidermal Growth Factor Receptor 3-Directed Antibody-Drug Conjugate, in Patients With Previously Treated Human Epidermal Growth Factor Receptor 3-Expressing Metastatic Breast Cancer: A Multicenter, Phase I/II Trial.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 102 papers, 1 of them a synthesis that pooled it.
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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.
Who cites it
102 citing papers in PubMed, 1 synthesis or guideline pooled it, 111 citations in OpenAlex.
- Integrated Two-Analyte Population Pharmacokinetics Model of Patritumab Deruxtecan (HER3-DXd) Monotherapy in Patients with Solid Tumors.Clinical pharmacokinetics · 2025Pooled it
- Patritumab deruxtecan in HRNature medicine · 2025Trial
- Patritumab deruxtecan in leptomeningeal metastatic disease of solid tumors: the phase 2 TUXEDO-3 trial.Nature medicine · 2025Trial
- Current and future therapies for triple-negative breast cancer.Journal of hematology & oncology · 2026Review
- ATR inhibition potentiates the antitumor efficacy of HER3-DXd in HER3-positive/HR-positive breast cancer by increasing DNA damage.British journal of cancer · 2026Article
- Antibody-drug conjugates in breast cancer brain and leptomeningeal metastases: mechanistic insights and therapeutic progress.Cancer metastasis reviews · 2026Review
- HER2 intratumoral heterogeneity predicts response to neoadjuvant therapy in HER2-positive breast cancer: impact and interplay with HER3 expression.Virchows Archiv : an international journal of pathology · 2026Article
- Antibody-drug conjugates in breast cancer: Progress and future directions.Cell reports. Medicine · 2026Review
- Human epidermal growth factor receptor 3-targeted near-infrared photoimmunotherapy in a xenograft mouse model of breast cancer.BMC cancer · 2026Article
- Antibody-Drug Conjugates Beyond HER2 in Non-Small Cell Lung Cancer (NSCLC): Mechanisms, Emerging Targets, and Future Directions.Biomolecules · 2026Review
- Expression of HER2, HER3, and TROP2 in primary tumors and brain metastases of breast cancer.Breast cancer (Tokyo, Japan) · 2026Article
- Evolving antibody-drug conjugates in breast cancer from precision delivery to tumor microenvironment reprogramming.Journal of hematology & oncology · 2026Review
- Quantification of Antibody-Drug Conjugate Targets in Head and Neck Squamous Cell Carcinoma.Molecular cancer therapeutics · 2026Article
- Targeted Therapies for Each Subtype of Breast Cancer.MedComm · 2026Review
- New Perspectives in the Management of Triple-Negative Breast Cancer.Breast care (Basel, Switzerland) · 2026Review
- Roles of Her3 in carcinogenesis and advances in Her3-targeted cancer therapy.Discover oncology · 2026Review
- HER3 beyond the canonical paradigm: a versatile signaling hub in oncogenesis and therapeutic resistance.Journal of translational medicine · 2026Review
- The Impact of HER3 Dynamics Altered by HER3-DXd Alone and in Combination with Driver Oncogene Inhibitors on HER3-DXd Efficacy.International journal of molecular sciences · 2026Article
- Trop2-Based Antibody-Drug Conjugates: Emerging Strategy and Progress in Triple-Negative Breast Cancer Therapy.Current oncology (Toronto, Ont.) · 2026Review
- Clinical advances and challenges of antibody-mediated targeted drug delivery in breast cancer therapeutics.Discover oncology · 2026Review
42 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
25 authors at 18 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeHuman epidermal growth factor receptor 3 (HER3) is broadly expressed in breast cancer; high expression is associated with an adverse prognosis. Patritumab deruxtecan (HER3-DXd) is an investigational HER3-targeted antibody-drug conjugate that is being evaluated as a novel treatment in HER3-expressing advanced breast cancer in the U31402-A-J101 study.
methodsAdults with disease progression on previous therapies were eligible. Patients in the dose-escalation, dose-finding, and dose-expansion parts received HER3-DXd 1.6-8.0 mg/kg intravenously once every 3 weeks or one of two alternative dosing regimens. In the dose-escalation part, the primary objectives were to determine the maximum tolerated dose and recommended dose for expansion (RDE). The safety and efficacy of the RDE were assessed during dose expansion.
resultsOne hundred eighty-two enrolled patients received ≥1 dose of HER3-DXd. Patients had a median of five previous therapies for advanced disease. Efficacy results are reported across clinical subtypes: hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-negative) breast cancer (n = 113; objective response rate [ORR], 30.1%; median progression-free survival [mPFS], 7.4 months), triple-negative breast cancer (n = 53; ORR, 22.6%; mPFS, 5.5 months), and HER2-positive breast cancer (n = 14; ORR, 42.9%; mPFS, 11.0 months). Objective responses were observed in cancers with HER3-high and HER3-low membrane expression. Dose-limiting toxicities observed during dose selection were decreased platelet count and elevated aminotransferases. In dose expansion, GI and hematologic toxicities were the most common treatment-emergent adverse events (TEAEs) observed. Grade ≥3 TEAEs were observed in 71.4% of patients, and 9.9% discontinued treatment because of TEAEs. Three grade 3 and one grade 5 treatment-related interstitial lung disease events occurred.
conclusionHER3-DXd demonstrated a manageable safety profile and durable efficacy in heavily pretreated patients across clinical subtypes. These data warrant further evaluation of HER3-DXd in patients with HER3-expressing metastatic breast cancer.
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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.