Trial reportThe oncologist2013
Cardiac tolerability of pertuzumab plus trastuzumab plus docetaxel in patients with HER2-positive metastatic breast cancer in CLEOPATRA: a randomized, double-blind, placebo-controlled phase III study.
Trial report in The oncologist, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 79 papers, 3 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
79 citing papers in PubMed, 3 syntheses or guidelines pooled it, 156 citations in OpenAlex.
- Cardiotoxic Effects of Antibody Drug Conjugates vs Standard Chemotherapy in ERBB2-Positive Advanced Breast Cancer: A Systematic Review and Meta-Analysis.JAMA network open · 2025Pooled it
- Pertuzumab combined with trastuzumab compared to trastuzumab in the treatment of HER2-positive breast cancer: A systematic review and meta-analysis of randomized controlled trials.Frontiers in oncology · 2022Pooled it
- Breast cancer, version 3.2013: featured updates to the NCCN guidelines.Journal of the National Comprehensive Cancer Network : JNCCN · 2013Guideline
- Neoadjuvant anthracycline-based (5-FEC) or anthracycline-free (docetaxel/carboplatin) chemotherapy plus trastuzumab and pertuzmab in HER2 + BC patients according to their TOP2A: a multicentre, open-label, non-randomized phase II trial.Breast cancer research and treatment · 2024Trial
- Neoadjuvant-adjuvant pertuzumab in HER2-positive early breast cancer: final analysis of the randomized phase III PEONY trial.Nature communications · 2024Trial
- Cardiac safety of dual anti-HER2 blockade with pertuzumab plus trastuzumab in early HER2-positive breast cancer in the APHINITY trial.ESMO open · 2023Trial
- Real-World Evidence of Trastuzumab, Pertuzumab, and Docetaxel Combination as a First-Line Treatment for Korean Patients with HER2-Positive Metastatic Breast Cancer.Cancer research and treatment · 2022Trial
- Efficacy and Safety of Pertuzumab and Trastuzumab Administered in a Single Infusion Bag, Followed by Vinorelbine: VELVET Cohort 2 Final Results.The oncologist · 2017Trial
- Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer.The New England journal of medicine · 2017Trial
- Cardiac Safety of Paclitaxel Plus Trastuzumab and Pertuzumab in Patients With HER2-Positive Metastatic Breast Cancer.The oncologist · 2016Trial
- Neoadjuvant chemotherapy of breast cancer with pirarubicin versus epirubicin in combination with cyclophosphamide and docetaxel.Tumour biology : the journal of the International Society for Oncodevelopmental Biology and Medicine · 2015Trial
- Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer.The New England journal of medicine · 2015Trial
- Treatment of older patients with HER2-positive metastatic breast cancer with pertuzumab, trastuzumab, and docetaxel: subgroup analyses from a randomized, double-blind, placebo-controlled phase III trial (CLEOPATRA).Breast cancer research and treatment · 2013Trial
- Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA study): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 study.The Lancet. Oncology · 2013Trial
- Cardiovascular Toxicity of Novel HER2-Targeted Agents and Multikinase Inhibitors in Oncology: From Mechanisms to Real-World Clinical Evidence.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Molecular Profiling and Targeted Therapeutic Strategies in Breast Cancer: Clinical Integration of HER2, CDK4/6, and PI3K Inhibition with Trastuzumab, Abemaciclib and Alpelisib.Journal of clinical medicine · 2026Review
- Cardiotoxicity of monoclonal antibody-based therapies in breast cancer: a contemporary narrative review.Cardio-oncology (London, England) · 2026Review
- Kidney function changes associated with trastuzumab use in women with breast cancer: a retrospective cohort study.Breast cancer research and treatment · 2026Article
- Leucogen-induced pemphigus foliaceus: the first case report.Frontiers in immunology · 2026Article
- Cancer Therapy-Related Cardiac Dysfunction in Patients With Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer Treated With Trastuzumab and Pertuzumab.Circulation reports · 2025Article
19 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
10 authors at 8 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionWe report cardiac tolerability of pertuzumab plus trastuzumab plus docetaxel versus placebo plus trastuzumab plus docetaxel observed in the phase III study CLEOPATRA in patients with HER2-positive first-line metastatic breast cancer (MBC). PATIENTS AND
methodsLeft ventricular ejection fraction (LVEF) ≥ 50% and ECOG performance status of 0 or 1 were required for study entry. During the study, LVEF assessments took place every 9 weeks. Pertuzumab/placebo was given at 840 mg, then 420 mg q3w; trastuzumab was administered at 8 mg/kg, then 6 mg/kg q3w, and docetaxel was initiated at 75 mg/m(2) q3w.
resultsThe incidence of cardiac adverse events (all grades) was 16.4% in the placebo arm and 14.5% in the pertuzumab arm, with left ventricular systolic dysfunction (LVSD, all grades) being the most frequently reported event (8.3% versus 4.4% in the placebo and pertuzumab arm). Declines in LVEF by ≥ 10% points from baseline and to <50% were reported in 6.6% and 3.8% of patients in the placebo and pertuzumab arm, respectively. Seventy-two percent (placebo arm) and 86.7% (pertuzumab arm) of those patients recovered to a value ≥ 50%. The incidence of symptomatic LVSD was low, occurring in 1.8% (n = 7) versus 1.0% (n = 4) of patients in the placebo and pertuzumab arm. In 8/11 patients, the symptomatic LVSD had resolved at data cutoff.
conclusionThe combination of pertuzumab plus trastuzumab plus docetaxel did not increase the incidence of cardiac adverse events, including LVSD, compared with the control arm in HER2-positive MBC. The majority of cardiac adverse events were reversible.
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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.