Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2009
Concurrent trastuzumab and HER2/neu-specific vaccination in patients with metastatic breast cancer.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04895761 (Phase Ib Study of Neoadjuvant DPX-Survivac, Aromatase Inhibition, and With/Without Radiotherapy or Cyclophosphamide in HR+HER2- Breast Cancer), which is not on this map. Cited by 158 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.
Phase Ib Study of Neoadjuvant DPX-Survivac, Aromatase Inhibition, and With/Without Radiotherapy or Cyclophosphamide in HR+HER2- Breast Cancer
Who cites it
158 citing papers in PubMed, 1 synthesis or guideline pooled it, 296 citations in OpenAlex.
- A systematic review of the efficacy of cancer vaccines in advanced breast cancer.Breast cancer (Tokyo, Japan) · 2025Pooled it
- Viral based vaccine TG4010 induces broadening of specific immune response and improves outcome in advanced NSCLC.Journal for immunotherapy of cancer · 2017Trial
- Trial
- Improved Survival of HER2+ Breast Cancer Patients Treated with Trastuzumab and Chemotherapy Is Associated with Host Antibody Immunity against the HER2 Intracellular Domain.Cancer research · 2016Trial
- A feasibility study of cyclophosphamide, trastuzumab, and an allogeneic GM-CSF-secreting breast tumor vaccine for HER2+ metastatic breast cancer.Cancer immunology research · 2014Trial
- Immune impact induced by PROSTVAC (PSA-TRICOM), a therapeutic vaccine for prostate cancer.Cancer immunology research · 2014Trial
- Vaccination with a plasmid DNA encoding HER-2/neu together with low doses of GM-CSF and IL-2 in patients with metastatic breast carcinoma: a pilot clinical trial.Journal of translational medicine · 2010Trial
- Safety and immunogenicity of a tri-antigen vaccine targeting IGFBP-2, HER2, and IGF-IR in participants with non-metastatic breast cancer.Journal for immunotherapy of cancer · 2026Article
- HER-2 therapeutic vaccine is not hampered by concurrent HER-2 monoclonal antibody.NPJ vaccines · 2026Article
- Identification of tumor-associated antigens with multi-cancer therapeutic potential.Frontiers in immunology · 2026Article
- Therapeutic cancer vaccines: navigating clinical translation and multimodal synergy.Frontiers in immunology · 2026Review
- Biomarkers for predicting and monitoring the efficacy of cancer vaccines.Frontiers in oncology · 2026Review
- Predicting Durable Anti-tumor Immune Responses after Cancer Vaccines.Journal of cancer immunology · 2026Article
- Review
- A superantigen-based MHC class II-targeted cancer immunotherapy for the treatment of acute myeloid leukemia.Blood cancer journal · 2025Article
- Pharmacological Prevention in Breast Cancer: Current Evidence, Challenges, and Future Directions.Cancers · 2025Review
- The HER2 target for designing novel multi-peptide vaccine against breast cancer using immunoinformatics and molecular dynamic simulation.Biochemistry and biophysics reports · 2025Article
- Immuno-Oncology at the Crossroads: Confronting Challenges in the Quest for Effective Cancer Therapies.International journal of molecular sciences · 2025Review
- Cancer Vaccines: A Novel Revolutionized Approach to Cancer Therapy.Indian journal of clinical biochemistry : IJCB · 2025Review
- Advancing Breast Cancer Treatment: The Role of Immunotherapy and Cancer Vaccines in Overcoming Therapeutic Challenges.Vaccines · 2025Review
98 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
15 authors at 1 institution in 1 country.
Funding
Abstract
purposeThe primary objectives of this phase I/II study were to evaluate the safety and immunogenicity of combination therapy consisting of concurrent trastuzumab and human epidermal growth factor receptor 2 (HER2)/neu-specific vaccination in patients with HER2/neu-overexpressing metastatic breast cancer. PATIENTS AND
methodsTwenty-two patients with stage IV HER2/neu-positive breast cancer receiving trastuzumab therapy were vaccinated with an HER2/neu T-helper peptide-based vaccine. Toxicity was graded according to National Cancer Institute criteria, and antigen specific T-cell immunity was assessed by interferon gamma enzyme-linked immunosorbent spot assay. Data on progression-free and overall survival were collected.
resultsConcurrent trastuzumab and HER2/neu vaccinations were well tolerated, with 15% of patients experiencing an asymptomatic decline in left ventricular ejection fraction below the normal range during combination therapy. Although many patients had pre-existing immunity specific for HER2/neu and other breast cancer antigens while treated with trastuzumab alone, that immunity could be significantly boosted and maintained with vaccination. Epitope spreading within HER2/neu and to additional tumor-related proteins was stimulated by immunization, and the magnitude of the T-cell response generated was significantly inversely correlated with serum transforming growth factor beta levels. At a median follow-up of 36 months from the first vaccine, the median overall survival in the study population has not been reached.
conclusionCombination therapy with trastuzumab and a HER2/neu vaccine is associated with minimal toxicity and results in prolonged, robust, antigen-specific immune responses in treated patients.
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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.