Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2025
Datopotamab Deruxtecan Versus Chemotherapy in Previously Treated Inoperable/Metastatic Hormone Receptor-Positive Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer: Primary Results From TROPION-Breast01.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 130 papers, 10 of them syntheses that pooled it.
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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.
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
130 citing papers in PubMed, 10 syntheses or guidelines pooled it.
- Assessment of Trophoblast cell surface antigen 2 (Trop-2) expression and its clinical significance in breast cancer: a multi-level analysis of protein and gene expression.BMC medicine · 2026Pooled it
- Prevalence of antibody drug conjugated-induced nausea and vomiting (ADCINV) in patients with cancer.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Pooled it
- Guidance for Canadian Breast Cancer Practice: National Consensus Recommendations for the Systemic Treatment of Patients with HR+/HER2- Metastatic Breast Cancer 2025.Current oncology (Toronto, Ont.) · 2026Guideline
- Survival disparities in HER2-low versus HER2-positive breast cancer: a systematic review of progression-free survival and overall survival.Frontiers in oncology · 2026Pooled it
- Datopotamab deruxtecan in breast cancer treatment: a systematic review of clinical efficacy and safety.Frontiers in immunology · 2026Pooled it
- SEOM-GEICAM-SOLTI clinical guidelines in advanced breast cancer (UPDATE 2025).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Guideline
- The efficacy and safety of datopotamab deruxtecan (Dato-DXd) in advanced solid tumors: a systematic review and meta-analysis.European journal of medical research · 2025Pooled it
- A meta-analysis and systematic review of the first Trop-2-targeting antibody-drug conjugate (sacituzumab govitecan) in treating metastatic breast cancer.European journal of clinical pharmacology · 2025Pooled it
- Comparative efficacy of antibody-drug conjugates and chemotherapy for malignant tumors: a systematic review and meta-analysis.Frontiers in oncology · 2025Pooled it
- Treatment-Related Toxicities of Antibody-Drug Conjugates in Breast Cancer: A Bayesian Network Meta-Analysis.Cancer control : journal of the Moffitt Cancer CenterPooled it
- Sacituzumab govitecan in Japanese participants with HR+/HER2- metastatic breast cancer: primary results from the phase II ASCENT-J02 study.Japanese journal of clinical oncology · 2026Trial
- Patritumab deruxtecan in HRNature medicine · 2025Trial
- Clinical toxicity of ADCs and ICI-ADC combinations: mechanisms, patterns and management.Nature reviews. Clinical oncology · 2026Review
- Toward targeted therapeutics for lobular breast cancer.The Journal of clinical investigation · 2026Review
- Antibody-drug conjugates in breast cancer: redefining targeted therapy.The Journal of clinical investigation · 2026Review
- Dermatologic adverse events associated with Sacituzumab Govitecan: an international retrospective study from the EADV Task Force "Dermatology for Cancer Patients" and pharmacovigilance analysis.Breast cancer research and treatment · 2026Article
- Tumor-associated calcium signal transducer 2 expression as a promising therapeutic target in esophageal squamous cell carcinoma: a combined the Cancer Genome Atlas and an institutional cohort.Esophagus : official journal of the Japan Esophageal Society · 2026Article
- Article
- Oral toxicities secondary to TROP2 and HER2-directed antibody drug conjugates: a multicenter retrospective cohort study.The oncologist · 2026Article
- Real-world outcomes of datopotamab deruxtecan after trastuzumab deruxtecan in hormone receptor-positive, HER2-negative metastatic breast cancer.Breast cancer (Tokyo, Japan) · 2026Article
70 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
24 authors.
Funding
Abstract
purposeThe global, phase 3, open-label, randomized TROPION-Breast01 study assessed the trophoblast cell surface antigen 2-directed antibody-drug conjugate datopotamab deruxtecan (Dato-DXd) versus investigator's choice of chemotherapy (ICC) in hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer.
methodsAdult patients with inoperable/metastatic HR+/HER2‒ breast cancer, who had disease progression on endocrine therapy, for whom endocrine therapy was unsuitable, and had received one to two previous lines of chemotherapy in the inoperable/metastatic setting, were randomly assigned 1:1 to Dato-DXd (6 mg/kg once every 3 weeks) or ICC (eribulin/vinorelbine/capecitabine/gemcitabine). Dual primary end points were progression-free survival (PFS) by blinded independent central review (BICR) and overall survival (OS).
resultsPatients were randomly assigned to Dato-DXd (n = 365) or ICC (n = 367). Dato-DXd significantly reduced the risk of progression or death versus ICC (PFS by BICR hazard ratio [HR], 0.63 [95% CI, 0.52 to 0.76];
conclusionPatients receiving Dato-DXd had statistically significant and clinically meaningful improvement in PFS and a favorable and manageable safety profile, compared with ICC. Results support Dato-DXd as a novel treatment option for patients with inoperable/metastatic HR+/HER2‒ breast cancer who have received one to two previous lines of chemotherapy in this setting.
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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.