Trial reportThe oncologist2011
Phase III multicenter clinical trial of the sialyl-TN (STn)-keyhole limpet hemocyanin (KLH) vaccine for metastatic breast cancer.
Trial report in The oncologist, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 139 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
139 citing papers in PubMed, 1 synthesis or guideline pooled it, 248 citations in OpenAlex.
- A systematic review of the efficacy of cancer vaccines in advanced breast cancer.Breast cancer (Tokyo, Japan) · 2025Pooled it
- Globo H-KLH vaccine adagloxad simolenin (OBI-822)/OBI-821 in patients with metastatic breast cancer: phase II randomized, placebo-controlled study.Journal for immunotherapy of cancer · 2020Trial
- Active idiotypic vaccination versus control immunotherapy for follicular lymphoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2014Trial
- Synthesis and In Vivo Immunological Evaluation of Novel Saponin-Antigen Conjugates Incorporating Tumor-Associated Carbohydrate and Peptide Epitopes.Chemistry (Weinheim an der Bergstrasse, Germany) · 2026Article
- Unlocking the Potency of Keyhole Limpet Hemocyanin: Structural Insights, Immunological Mechanisms, and Therapeutic Frontiers.International journal of molecular sciences · 2026Review
- From Glycocode to Precision Oncology: Therapeutic Strategies Targeting Aberrant O-GalNAc Glycosylation in Cancer.Chemical reviews · 2026Review
- Cancer-associated alterations in O-GalNAc glycosylation.Glycobiology · 2026Review
- Fluorinated carbohydrate-based vaccines.Chemical science · 2026Review
- Comprehensive Profiling Reveals Sialyl-Tn Upregulation and Prognostic Value in Prostate Cancer.Pathology international · 2026Article
- Breast cancer immunotherapy: mechanisms of immune evasion, biomarkers, and emerging therapeutic strategies.Molecular cancer · 2026Review
- Comprehensive profiling reveals Sialyl-Tn upregulation and prognostic value in prostate cancer.bioRxiv : the preprint server for biology · 2026Article
- IFN-γ and TLR agonist co-adjuvants enhance the efficacy of a lipid-PLGA hybrid nanoparticle-based oxycodone vaccine.Biomaterials · 2026Article
- Pan-carcinoma sialyl-Tn-targeting expands CAR therapy to solid tumors.Cell reports. Medicine · 2025Article
- The Landmark Series: Therapeutic Cancer Vaccine Strategies for Cold Tumors.Annals of surgical oncology · 2025Review
- Immunotherapy in Breast Cancer: Beyond Immune Checkpoint Inhibitors.International journal of molecular sciences · 2025Review
- Advancing Non-Invasive Colorectal Cancer Screening: Exploring the Potential of Monoclonal Antibody L2A5.International journal of molecular sciences · 2025Article
- Tumor Glycosylation: A Main Player in the Modulation of Immune Responses.European journal of immunology · 2025Review
- Recent Advancements in Immunotherapy for the Treatment of Metastatic Breast Cancer.Cancer treatment and research · 2025Review
- Tumor-associated Tn and STn antigens: from molecular mechanism to precision diagnosis and treatment.Frontiers in immunology · 2025Review
- Current and future immunotherapy for breast cancer.Journal of hematology & oncology · 2024Review
79 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
13 authors at 10 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThis double-blind, randomized, phase III clinical trial evaluated time to progression (TTP) and overall survival in women with metastatic breast cancer (MBC) who received sialyl-TN (STn) keyhole limpet hemocyanin (KLH) vaccine. Secondary endpoints included vaccine safety and immune response. EXPERIMENTAL
designThe study population consisted of 1,028 women with MBC across 126 centers who had previously received chemotherapy and had had either a complete or a partial response or no disease progression. All women received one-time i.v. cyclophosphamide (300 mg/m(2)) 3 days before s.c. injection of 100 μg STn-KLH plus adjuvant (treatment group) or 100 μg KLH plus adjuvant (control group) at weeks 0, 2, 5, and 9. Subsequently, STn-KLH without adjuvant or KLH without adjuvant was then administered monthly for 4 months, and then quarterly until disease progression, without cyclophosphamide.
resultsSTn-KLH vaccine was well tolerated; patients had mild to moderate injection-site reactions and reversible flu-like symptoms. Week-12 antibody testing revealed high specific IgG titers and a high rate of IgM-to-IgG seroconversion; the median IgG titers in STn-KLH recipients were 320 (anti-ovine submaxillary mucin) and 20,480 (anti-STn), with no detectable antimucin antibodies in the control group. The TTP was 3.4 months in the treatment group and 3.0 months in the control group. The median survival times were 23.1 months and 22.3 months, respectively.
conclusionsAlthough STn-KLH was well tolerated in this largest to date metastatic breast cancer vaccine trial, no overall benefit in TTP or survival was observed. Lessons were learned for future vaccine study designs.
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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.