Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2020
Results of a Randomized Phase IIb Trial of Nelipepimut-S + Trastuzumab versus Trastuzumab to Prevent Recurrences in Patients with High-Risk HER2 Low-Expressing Breast Cancer.
Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01570036 (Combination Immunotherapy With Herceptin and the HER2 Vaccine E75 in Low and Intermediate HER2-expressing Breast Cancer Patients to Prevent Recurrence), which is not on this map. Cited by 59 papers.
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.
Combination Immunotherapy With Herceptin and the HER2 Vaccine E75 in Low and Intermediate HER2-expressing Breast Cancer Patients to Prevent Recurrence
Who cites it
59 citing papers in PubMed, 90 citations in OpenAlex.
- Phase II Trial of Nelipepimut-S Peptide Vaccine in Women with Ductal Carcinoma In Situ.Cancer prevention research (Philadelphia, Pa.) · 2023Trial
- Right-sizing treatment for HER2-positive breast cancer: evolving algorithms across the disease continuum.Nature reviews. Clinical oncology · 2026Review
- Advances in Immunotherapy for Breast Cancer: Up-to-date Strategies of Immune Checkpoint Inhibitors and Therapeutic Vaccines.Current treatment options in oncology · 2026Review
- HER-2 therapeutic vaccine is not hampered by concurrent HER-2 monoclonal antibody.NPJ vaccines · 2026Article
- Immuno-oncological Challenges and Chemoresistance in Veterinary Medicine: Probiotics as a New Strategic Tool.Probiotics and antimicrobial proteins · 2026Review
- Therapeutic cancer vaccines: navigating clinical translation and multimodal synergy.Frontiers in immunology · 2026Review
- β-amino acid substitution in the SIINFEKL antigen alters immunological recognition.Cancer biology & therapy · 2025Article
- Artificial Intelligence and the Evolving Landscape of Immunopeptidomics.Proteomics. Clinical applications · 2025Review
- Breaking new ground in ductal carcinoma in situ management: the promise of intratumoral messenger ribonucleic acid-2752 and pembrolizumab.Annals of translational medicine · 2025Article
- Immunotherapy in breast cancer: current landscape and emerging trends.Experimental hematology & oncology · 2025Review
- Peptide-based drugs in immunotherapy: current advances and future prospects.Medical oncology (Northwood, London, England) · 2025Review
- PCI-DB: a novel primary tissue immunopeptidome database to guide next-generation peptide-based immunotherapy development.Journal for immunotherapy of cancer · 2025Article
- Advances in Therapeutic Cancer Vaccines, Their Obstacles, and Prospects Toward Tumor Immunotherapy.Molecular biotechnology · 2025Review
- Cancer vaccines: current status and future directions.Journal of hematology & oncology · 2025Review
- Harnessing Oncolytic Viruses for Targeted Therapy in Triple-Negative Breast Cancer.International journal of medical sciences · 2025Review
- Targeting RTKs/nRTKs as promising therapeutic strategies for the treatment of triple-negative breast cancer: evidence from clinical trials.Military Medical Research · 2024Review
- Updates in Immunotherapy for Pancreatic Cancer.Journal of clinical medicine · 2024Review
- HER2-Low Breast Cancer: Now and in the Future.Cancer research and treatment · 2024Review
- Emerging treatments in HER2-positive advanced breast cancer: Keep raising the bar.Cell reports. Medicine · 2024Review
- Peptide-Drug Conjugates: Design, Chemistry, and Drug Delivery System as a Novel Cancer Theranostic.ACS pharmacology & translational science · 2024Review
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 5 institutions in 1 country.
Funding
Abstract
purposePreclinical data provide evidence for synergism between HER2-targeted peptide vaccines and trastuzumab. The efficacy of this combination was evaluated in patients with HER2 low-expressing breast cancer in the adjuvant setting. PATIENTS AND
methodsA phase IIb, multicenter, randomized, single-blinded, controlled trial enrolled disease-free patients after standard therapy completion (NCT01570036). Eligible patients were HLA-A2, A3, A24, and/or A26+, and had HER2 IHC 1+/2+, FISH nonamplified breast cancer, that was node positive and/or hormone receptor-negative [triple-negative breast cancer (TNBC)]. Patients received trastuzumab for 1 year and were randomized to placebo (GM-CSF, control) or nelipepimut-S (NPS) with GM-CSF. Primary outcome was 24-month disease-free survival (DFS). Secondary outcomes were 36-month DFS, safety, and immunologic response.
resultsOverall, 275 patients were randomized; 136 received NPS with GM-CSF, and 139 received placebo with GM-CSF. There were no clinicopathologic differences between groups. Concurrent trastuzumab and NPS with GM-CSF was safe with no additional overall or cardiac toxicity compared with control. At median follow-up of 25.7 (interquartile range, 18.4-32.7) months, estimated DFS did not significantly differ between NPS and control [HR, 0.62; 95% confidence interval (CI), 0.31-1.25;
conclusionsThe combination of NPS with trastuzumab is safe. In HER2 low-expressing breast cancer, no significant difference in DFS was seen in the intention-to-treat analysis; however, significant clinical benefit was seen in patients with TNBC. These findings warrant further investigation in a phase III randomized trial.
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.