Trial reportBritish journal of clinical pharmacology2017
Population pharmacokinetics and exposure-response of trastuzumab emtansine in advanced breast cancer previously treated with ≥2 HER2-targeted regimens.
Trial report in British journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01419197 (A Phase III Randomized, Multicenter, Two Arm, Open-label Trial to Evaluate the Efficacy of Trastuzumab Emtansine Compared With Treatment of Physician's Choice in Patients With HER2-positive Metastatic Breast Cancer Who Have Received at Least Two Prior Regimens of HER2 Directed Therapy), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled 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.
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 Phase III Randomized, Multicenter, Two Arm, Open-label Trial to Evaluate the Efficacy of Trastuzumab Emtansine Compared With Treatment of Physician's Choice in Patients With HER2-positive Metastatic Breast Cancer Who Have Received at Least Two Prior Regimens of HER2 Directed Therapy
Who cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.
- Postmarketing Assessment of Antibody-Drug Conjugates: Proof-of-Concept Using Model-Based Meta-Analysis and a Clinical Utility Index Approach.CPT: pharmacometrics & systems pharmacology · 2025Pooled it
- Population pharmacokinetics and exposure-response of trastuzumab emtansine in advanced breast cancer previously treated with ≥2 HER2-targeted regimens.British journal of clinical pharmacology · 2017Trial
- Exposure-Response Relationships of Antibody Drug Conjugates in Solid Tumours.Clinical pharmacokinetics · 2026Review
- Predictive Factors of Antibody-Drug Conjugate Treatment in Metastatic Breast Cancer: A Narrative Review.Cancers · 2024Review
- Development, efficacy and side effects of antibody‑drug conjugates for cancer therapy (Review).Molecular and clinical oncology · 2023Review
- Applying interpretable machine learning workflow to evaluate exposure-response relationships for large-molecule oncology drugs.CPT: pharmacometrics & systems pharmacology · 2022Article
- Performance of Cox proportional hazard models on recovering the ground truth of confounded exposure-response relationships for large-molecule oncology drugs.CPT: pharmacometrics & systems pharmacology · 2022Article
- Deep learning prediction of patient response time course from early data via neural-pharmacokinetic/pharmacodynamic modelling.Nature machine intelligence · 2021Article
- Neural-ODE for pharmacokinetics modeling and its advantage to alternative machine learning models in predicting new dosing regimens.iScience · 2021Article
- Clinical Pharmacology of Antibody-Drug Conjugates.Antibodies (Basel, Switzerland) · 2021Review
- Article
- Characterizing Exposure-Response Relationship for Therapeutic Monoclonal Antibodies in Immuno-Oncology and Beyond: Challenges, Perspectives, and Prospects.Clinical pharmacology and therapeutics · 2020Review
- Impact of Physiologically Based Pharmacokinetics, Population Pharmacokinetics and Pharmacokinetics/Pharmacodynamics in the Development of Antibody-Drug Conjugates.Journal of clinical pharmacology · 2020Review
- Evaluating Trastuzumab in the treatment of HER2 positive breast cancer.Histology and histopathology · 2020Review
- Comparison of Bevacizumab Quantification Results in Plasma of Non-small Cell Lung Cancer Patients Using Bioanalytical Techniques Between LC-MS/MS, ELISA, and Microfluidic-based Immunoassay.The AAPS journal · 2019Article
- Reverse Translation of US Food and Drug Administration Reviews of Oncology New Molecular Entities Approved in 2011-2017: Lessons Learned for Anticancer Drug Development.Clinical and translational science · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsWe conducted population pharmacokinetic (PopPK) and exposure-response analyses for trastuzumab emtansine (T-DM1), to assess the need for T-DM1 dose optimization in patients with low exposure by using TH3RESA [A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Patients With human epidermal growth factor receptor 2 (HER2)-positive Breast Cancer Who Have Received at Least Two Prior Regimens of HER2-directed Therapy] study data (NCT01419197). The randomized phase III TH3RESA study investigated T-DM1 vs. treatment of physician's choice (TPC) in patients with heavily pretreated HER2-positive advanced breast cancer.
methodsWe compared a historical T-DM1 PopPK model with T-DM1 pharmacokinetics in TH3RESA and performed exposure-response analyses using model-predicted cycle 1 maximum concentration (C
resultsT-DM1 concentrations in TH3RESA were described well by the historical PopPK model. Patients with higher cycle 1 C
conclusionsExposure-response relationships for efficacy were inconsistent across exposure metrics. HRs for survival in patients in the lowest T-DM1 exposure quartile vs. matched TPC-treated patients suggest that, compared with TCP, the approved T-DM1 dose is unlikely to be detrimental to patients with low exposure.
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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.