Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2010
Open-label, phase II, multicenter, randomized study of the efficacy and safety of two dose levels of Pertuzumab, a human epidermal growth factor receptor 2 dimerization inhibitor, in patients with human epidermal growth factor receptor 2-negative metastatic breast cancer.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 113 papers, 3 of them syntheses 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
113 citing papers in PubMed, 3 syntheses or guidelines pooled it, 266 citations in OpenAlex.
- Survival outcomes in HER2-low versus HER2-zero breast cancer after neoadjuvant chemotherapy: a meta-analysis.World journal of surgical oncology · 2024Pooled it
- Pooled it
- Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update.Archives of pathology & laboratory medicine · 2014Guideline
- Preclinical study and phase 2 trial of neoadjuvant pyrotinib combined with chemotherapy in luminal/HER2-low breast cancer: PILHLE-001 study.Cell reports. Medicine · 2024Trial
- A phase IIa dose-finding and safety study of first-line pertuzumab in combination with trastuzumab, capecitabine and cisplatin in patients with HER2-positive advanced gastric cancer.British journal of cancer · 2014Trial
- Article
- Correlation of HER2 levels expression through HER2 mRNA PCR vs immunohistochemistry (IHC) in hormone receptor positive (HR+)/HER2 negative (HER2-) early breast cancer.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Article
- Proteogenomic Characterization Reveals Subtype-Specific Therapeutic Potential for HER2-Low Breast Cancer.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Article
- FDA-AACR Strategies for Optimizing Dosages for Oncology Drug Products: Selecting Optimized Dosages for Registrational Trials.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025Review
- Exploring immune activation patterns in HER2-low and HER2-ultralow breast cancer subtypes.The oncologist · 2025Article
- Comparison of Clinicopathological Characteristics for HER2-Null, HER2-Ultralow and HER2-Low Breast Cancer: A Single-Center Study.Medicina (Kaunas, Lithuania) · 2025Article
- Preclinical study of inetetamab combined with atezolizumab to synergistically inhibit HER2 and PD-L1 in the treatment of ovarian cancer.Molecular therapy. Oncology · 2025Article
- Clinical characteristics, metastasis patterns, and treatment outcomes of HER2-low breast cancer.Scientific reports · 2025Article
- Investigating HER2-Low in Early Breast Cancer: Prognostic Implications and Age-Related Prognostic Stratification.Cancer medicine · 2025Article
- Advances in research and current challenges in the treatment of advanced HER2-low breast cancer.Frontiers in cell and developmental biology · 2025Review
- Unveiling the traits of HER2-low breast cancer: a comparative analysis of IHC1+ vs IHC2+/ISH-negative subgroups - insights from a 3-year cohort study.Frontiers in oncology · 2025Article
- HER2-low status improves prognosis prediction in breast cancer patients receiving neoadjuvant treatment: A comparison of pathological stage, modified CPS+EG scoring system, and Neo-Bioscore.Chinese journal of cancer research = Chung-kuo yen cheng yen chiu · 2024Article
- Genomic landscape of circulating tumor DNA in HER2-low metastatic breast cancer.Signal transduction and targeted therapy · 2024Article
- The impact of HER2-low status on pathological complete response and disease-free survival in early-stage breast cancer.BMC cancer · 2024Article
- Utility of human epidermal growth factor 2 heterogeneity as a prognostic factor in triple-negative breast cancer.Medical molecular morphology · 2024Article
53 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
12 authors at 5 institutions in 4 countries.
Funding
Abstract
purposePertuzumab is a humanized monoclonal antibody inhibiting human epidermal growth factor receptor 2 (HER2) dimerization. The aim of this phase II trial was to assess the antitumor activity and safety profile of pertuzumab monotherapy in patients with HER2-negative metastatic breast cancer. The utility of biomarkers detected in paraffin-embedded tissue as predictors of response was also explored. PATIENTS AND
methodsThis was an international, multicenter, open-label, randomized phase II study. Patients (n = 79) with centrally confirmed HER2-negative metastatic breast cancer were randomly assigned to receive pertuzumab once every 3 weeks with a loading dose of 840 mg followed thereafter by either 420 mg (arm A) or 1,050 mg (arm B). Patients were stratified by country and prior taxane therapy.
resultsOf 79 patients who were randomly assigned, 78 were included in the intent-to-treat population. In arm A (n = 41), two patients had partial responses, and 18 patients (44%) experienced stable disease (SD) lasting > or = 12 weeks. In arm B (n = 37), SD was observed in 14 patients (38%). Overall, six of 78 patients responded or had SD > or = 6 months. Pertuzumab was generally well tolerated, and most adverse events were mild to moderate. Decline in left ventricular ejection fraction of > or = 10% and/or to less than 50% was observed in eight patients, with one case of congestive heart failure in arm A. Pharmacokinetic data supported a fixed dose of pertuzumab once every 3 weeks.
conclusionThe limited efficacy observed in this study, generally SD of relatively short duration, suggested little benefit of further investigation of single-agent pertuzumab in unselected patients with HER2-negative disease.
Indexed as
Identifiers
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.