Trial reportBreast cancer research : BCR2014
Relationship between HER2 expression and efficacy with first-line trastuzumab emtansine compared with trastuzumab plus docetaxel in TDM4450g: a randomized phase II study of patients with previously untreated HER2-positive metastatic breast cancer.
Trial report in Breast cancer research : BCR, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00679341 (A Randomized, Multicenter, Phase ii Study of the Efficacy and Safety of Trastuzumab-MCC-DM1 vs. Trastuzumab), which is not on this map. Cited by 29 papers, 2 of them syntheses that pooled it.
What it found
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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.
A Randomized, Multicenter, Phase ii Study of the Efficacy and Safety of Trastuzumab-MCC-DM1 vs. Trastuzumab (Herceptin®) and Docetaxel (Taxotere®) in Patients With Metastatic HER2-positive Breast Cancer Who Have Not Received Prior Chemotherapy for Metastatic Disease
Who cites it
29 citing papers in PubMed, 2 syntheses or guidelines pooled it, 60 citations in OpenAlex.
- Efficacy and safety of first-line therapy in patients with HER2-positive advanced breast cancer: a network meta-analysis of randomized controlled trials.Journal of cancer research and clinical oncology · 2024Pooled it
- Pooled it
- Trial
- Relationship between Tumor Biomarkers and Efficacy in EMILIA, a Phase III Study of Trastuzumab Emtansine in HER2-Positive Metastatic Breast Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2016Trial
- Past, present and future of drug conjugates for cancer therapy.Nature cancer · 2025Review
- The mechanisms of HER2 targeted ADCs are dependent on Rab GTPases.Therapeutic advances in medical oncology · 2025Article
- Quantitative evaluation of trastuzumab deruxtecan pharmacokinetics and pharmacodynamics in mouse models of varying degrees of HER2 expression.CPT: pharmacometrics & systems pharmacology · 2024Article
- Prognostic impact of HER2 biomarker levels in trastuzumab-treated early HER2-positive breast cancer.Breast cancer research : BCR · 2024Article
- Review
- Real-World Treatment Patterns and Outcomes Following First-Line Pertuzumab and Trastuzumab Among Patients with HER2+ Metastatic Breast Cancer.Oncology and therapy · 2023Article
- Predicting Response to Antibody Drug Conjugates: A Focus on Antigens' Targetability.The oncologist · 2023Article
- HER2DX ERBB2 mRNA expression in advanced HER2-positive breast cancer treated with T-DM1.Journal of the National Cancer Institute · 2023Article
- HER2+ Breast Cancer Escalation and De-Escalation Trial Design: Potential Role of Intrinsic Subtyping.Cancers · 2022Review
- High score of LDH plus dNLR predicts poor survival in patients with HER2-positive advanced breast cancer treated with trastuzumab emtansine.BMC cancer · 2022Article
- An Elaborate New Linker System Significantly Enhances the Efficacy of an HER2-Antibody-Drug Conjugate against Refractory HER2-Positive Cancers.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2021Article
- RAB5A expression is a predictive biomarker for trastuzumab emtansine in breast cancer.Nature communications · 2021Article
- Antibody Drug Conjugates in Glioblastoma - Is There a Future for Them?Frontiers in oncology · 2021Review
- The efficacy of ado-trastuzumab emtansine in patients with ERBB2-aberrant non-small cell lung cancer: a systematic review.Translational cancer research · 2020Article
- Article
- Significance of baseline neutrophil-to-lymphocyte ratio for progression-free survival of patients with HER2-positive breast cancer treated with trastuzumab emtansine.Scientific reports · 2019Article
Corrections and comments
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Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe purpose of this study was to retrospectively explore the relationship between human epidermal growth factor receptor 2 (HER2) messenger RNA (mRNA) expression and efficacy in patients receiving trastuzumab plus docetaxel (HT) or trastuzumab emtansine (T-DM1).
methodsPatients with HER2-positive, locally advanced or metastatic breast cancer (MBC) were randomly assigned to HT (n=70) or T-DM1 (n=67). HER2 status was assessed locally using immunohistochemistry or fluorescence in situ hybridization and confirmed retrospectively by central testing. HER2 mRNA expression was assessed using quantitative reverse transcriptase polymerase chain reaction.
resultsHER2 mRNA levels were obtained for 116/137 patients (HT=61; T-DM1=55). Median pretreatment HER2 mRNA was 8.9. The risk of disease progression in the overall population was lower with T-DM1 than with HT (hazard ratio (HR)=0.59; 95% confidence interval (CI) 0.36 to 0.97). This effect was more pronounced in patients with HER2 mRNA≥median (HR=0.39; 95% CI 0.18 to 0.85) versus <median (HR=0.85; 95% CI 0.44 to 1.67). In the T-DM1 arm, median progression-free survival (PFS) was not reached in patients with HER2 mRNA≥median and was 10.6 months in patients with HER2 mRNA<median. In the HT arm, PFS was 8.8 versus 9.8 months in patients with HER2 mRNA≥median versus<median, respectively. The effect of HER2 mRNA expression on objective response rates was less pronounced.
conclusionsThis exploratory analysis suggests that while overall, patients with HER2-positive MBC show improved PFS with T-DM1 relative to HT, the effect is enhanced in patients with tumor HER2 mRNA ≥ median.
trial registrationClinicalTrials.gov NCT00679341.
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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.