Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2015
Feasibility and cardiac safety of trastuzumab emtansine after anthracycline-based chemotherapy as (neo)adjuvant therapy for human epidermal growth factor receptor 2-positive early-stage breast cancer.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 50 papers, 1 of them a synthesis 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
50 citing papers in PubMed, 1 synthesis or guideline pooled it, 89 citations in OpenAlex.
- Safety of trastuzumab deruxtecan: A meta-analysis and pharmacovigilance study.Journal of clinical pharmacy and therapeutics · 2022Pooled it
- Cardiotoxicity and Cardiovascular Biomarkers in Patients With Breast Cancer: Data From the GeparOcto-GBG 84 Trial.Journal of the American Heart Association · 2020Trial
- Article
- T-DM1 with concurrent radiotherapy in HER2-positive breast cancer: preclinical evaluation and mechanisms, prediction, and exploration of adverse effects.Discover oncology · 2025Review
- Toxicities Associated with Sacituzumab Govitecan: Data from Clinical Trials and a Real-World Pharmacovigilance Database.Current medical science · 2025Article
- Recent advances of antibody-drug conjugates in treating breast cancer with different HER2 status.Therapeutic advances in medical oncology · 2025Review
- The mitigatory capabilities of exercise on breast cancer chemotherapy-induced cardiotoxicity.Frontiers in cell and developmental biology · 2025Review
- Investigation of Thrombocytopenia Associated with Trastuzumab Emtansine Treatment in Breast Cancer: A Retrospective Study in a Chinese Population.Breast cancer (Dove Medical Press) · 2025Article
- Escalation and optimisation of primary breast cancer treatment with antibody-drug conjugates.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2025Review
- Local treatment for oligoprogressive metastatic sites of breast cancer: efficacy, toxicities and future perspectives.Clinical & experimental metastasis · 2024Review
- Unveiling Neoadjuvant Therapy: Insights and Outlooks for HER2-Positive Early Breast Cancer.Current treatment options in oncology · 2024Review
- Article
- The promise and challenges of combination therapies with antibody-drug conjugates in solid tumors.Journal of hematology & oncology · 2024Review
- Incidence of antibody-drug conjugate-related hepatotoxicity in breast cancer: a systematic review and meta-analysis.Therapeutic advances in drug safety · 2024Article
- Cardiac toxicity of HER-2 targeting antibody-drug conjugates: overview and clinical implications.Future oncology (London, England) · 2024Review
- Incidence of HER2-targeted antibody-drug conjugates-related cardiac events: a meta-analysis.Journal of Cancer · 2024Article
- Treatment-related adverse events of antibody-drug conjugates in clinical trials: A systematic review and meta-analysis.Cancer innovation · 2023Article
- Characteristics and research status among clinical trials in cardio-oncology by bibliometric and visualized analysis.Cancer medicine · 2023Review
- Review
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 1 institution in 1 country.
Funding
Abstract
purposeTrastuzumab emtansine (T-DM1), an antibody-drug conjugate comprising the cytotoxic agent DM1, a stable linker, and trastuzumab, has demonstrated substantial activity in human epidermal growth factor receptor 2 (HER2) -positive metastatic breast cancer, raising interest in evaluating the feasibility and cardiac safety of T-DM1 in early-stage breast cancer (EBC). PATIENTS AND
methodsPatients (N = 153) with HER2-positive EBC and prechemotherapy left ventricular ejection fraction (LVEF) ≥ 55% received (neo)adjuvant doxorubicin plus cyclophosphamide or fluorouracil plus epirubicin plus cyclophosphamide followed by T-DM1 for four cycles. Patients could then receive three to four cycles of optional docetaxel with or without trastuzumab. T-DM1 was then resumed with optional radiotherapy (sequential or concurrent) for 1 year (planned) of HER2-directed therapy. The coprimary end points were rate of prespecified cardiac events and safety.
resultsMedian follow-up was 24.6 months. No prespecified cardiac events or symptomatic congestive heart failures were reported. Four patients (2.7%) had asymptomatic LVEF declines (≥ 10 percentage points from baseline to LVEF < 50%), leading to T-DM1 discontinuation in one patient. Of 148 patients who received ≥ one cycle of T-DM1, 82.4% completed the planned 1-year duration of HER2-directed therapy. During T-DM1 treatment, 38.5% and 2.7% of patients experienced grade 3 and 4 adverse events, respectively. Approximately 95% of patients receiving T-DM1 plus radiotherapy completed ≥ 95% of the planned radiation dose with delay ≤ 5 days.
conclusionUse of T-DM1 for approximately 1 year after anthracycline-based chemotherapy was feasible and generally well tolerated by patients with HER2-positive EBC, providing support for phase III trials of T-DM1 in this setting.
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What OpenQuestion holds
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.