ArticleAnnals of surgical oncology2017
Results of a Phase Ib Trial of Combination Immunotherapy with a CD8+ T Cell Eliciting Vaccine and Trastuzumab in Breast Cancer Patients.
Article in Annals of surgical oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 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
24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 42 citations in OpenAlex.
- Immunotherapy in HER2-Positive Breast Cancer: A Systematic Review.Breast care (Basel, Switzerland) · 2022Pooled it
- Intercepting Premalignant, Preinvasive Breast Lesions Through Vaccination.Frontiers in immunology · 2021Pooled it
- Efficacy of a Dual-Epitope Dendritic Cell Vaccine as Part of Combined Immunotherapy for HER2-Expressing Breast Tumors.Journal of immunology (Baltimore, Md. : 1950) · 2023Trial
- Robust CD8Frontiers in immunology · 2026Article
- From Mechanism to Medicine: Peptide-Based Approaches for Cancer Diagnosis and Therapy.Biomolecules · 2025Review
- The search for a TNBC vaccine: the guardian vaccine.Cancer biology & therapy · 2025Review
- Recent Advancements in Immunotherapy for the Treatment of Metastatic Breast Cancer.Cancer treatment and research · 2025Review
- Development of an obesity-related multi-gene prognostic model incorporating clinical characteristics in luminal breast cancer.iScience · 2024Article
- Emerging prospects of mRNA cancer vaccines: mechanisms, formulations, and challenges in cancer immunotherapy.Frontiers in immunology · 2024Review
- Review
- HER2/neu-based vaccination with li-Key hybrid, GM-CSF immunoadjuvant and trastuzumab as a potent triple-negative breast cancer treatment.Journal of cancer research and clinical oncology · 2023Review
- Review
- Immunological Landscape of HER-2 Positive Breast Cancer.Cancers · 2022Review
- Immunotherapy and immunobiomarker in breast cancer: current practice and future perspectives.American journal of cancer research · 2022Review
- Application of HER2 peptide vaccines in patients with breast cancer: a systematic review and meta-analysis.Cancer cell international · 2021Review
- Prospects of Immunotherapy for Triple-Negative Breast Cancer.Frontiers in oncology · 2021Review
- The Role of the Tumor Microenvironment in Developing Successful Therapeutic and Secondary Prophylactic Breast Cancer Vaccines.Vaccines · 2020Review
- Rapid Generation of Sustainable HER2-specific T-cell Immunity in Patients with HER2 Breast Cancer using a Degenerate HLA Class II Epitope Vaccine.Clinical cancer research : an official journal of the American Association for Cancer Research · 2020Article
- Immunotherapy in HER2-positive breast cancer: state of the art and future perspectives.Journal of hematology & oncology · 2019Review
- Therapeutic cancer vaccine: building the future from lessons of the past.Seminars in immunopathology · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundCD8+ T cell-eliciting vaccines are being investigated in breast cancer patients. Preclinical data showed that trastuzumab increases the susceptibility of tumor cells to lysis by vaccine-generated CD8+ T cells, suggesting potential benefit of a combination immunotherapy strategy. The current trial was undertaken to demonstrate the safety of this approach.
methodsThis study was designed as a dose-escalation trial enrolling clinically disease-free, human leukocyte antigen A2+ or A3+ , human epidermal growth factor receptor 2 (HER2)-positive breast cancer patients. Patients received 6-monthly inoculations of GP2+ granulocyte-macrophage colony-stimulating factor (GM-CSF) administered concurrently with standard-of-care trastuzumab. Local and systemic toxicity, as well as left ventricular ejection fraction (LVEF) were monitored. Immunologic responses were assessed in vivo by measuring the local reaction and in vitro using an interferon-γ enzyme-linked immunosorbent spot (ELISPOT) assay.
resultsSeventeen disease-free breast cancer patients were vaccinated. There were no dose-limiting or grade 3-5 local or systemic toxicities, and the median LVEF was unchanged from baseline after vaccination. Mean local reaction at initial inoculation was 28 ± 10 mm, increasing to 68 ± 8 mm at the final inoculation (p < 0.01). Mean ELISPOT response to GP2 increased from 47 ± 19 at baseline to 144 ± 60 (p = 0.13) after vaccination. Based on safety and immunologic data, the appropriate dose was determined to be 1000 μg of GP2 + 250 μg of GM-CSF.
conclusionThe GP2 + GM-CSF vaccine is safe and stimulates an immunologic response when administered concurrently with trastuzumab. An ongoing phase II trial is evaluating the efficacy of combining a CD8 T-cell-eliciting vaccine with trastuzumab in HER2-positive breast cancer patients.
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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.