Trial reportBreast cancer research and treatment2020
Safety and tolerability of subcutaneous trastuzumab at home administration, results of the phase IIIb open-label BELIS study in HER2-positive early breast cancer.
Trial report in Breast cancer research and treatment, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01926886 (A Single Arm Multi-center Study Investigating the at Home Administration of Trastuzumab Subcutaneous Vial for the Treatment of Patients With HER2-positive Early Breast Cancer), which is not on this map. Cited by 18 papers, 4 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.
A Single Arm Multi-center Study Investigating the at Home Administration of Trastuzumab Subcutaneous Vial for the Treatment of Patients With HER2-positive Early Breast Cancer
Who cites it
18 citing papers in PubMed, 4 syntheses or guidelines pooled it, 42 citations in OpenAlex.
- Delivery of intravenous anti-cancer therapy at home versus in hospital or community settings for adults with cancer.The Cochrane database of systematic reviews · 2025Pooled it
- Differences Between Intravenous and Subcutaneous Modes of Administration in Oncology from the Patient, Healthcare Provider, and Healthcare System Perspectives: A Systematic Review.Advances in therapy · 2024Pooled it
- Receptor-Defined Breast Cancer in Five East African Countries and Its Implications for Treatment: Systematic Review and Meta-Analysis.JCO global oncology · 2021Pooled it
- Pooled it
- Subcutaneous vs Intravenous Trastuzumab/Pertuzumab: A Time and Motion Substudy of a Phase II Trial of Adjuvant Trastuzumab/Pertuzumab for Stage I HER2+ Breast Cancer (ADEPT trial).JCO oncology practice · 2025Trial
- Transitioning Therapeutic Antibodies in Oncology from Intravenous to Hyaluronidase-Facilitated Subcutaneous Administration.Clinical pharmacokinetics · 2026Review
- Qualitative Interviews on the Experience of Orally vs. Intramuscularly Administered Endocrine Therapy for Advanced Breast Cancer: Patient and Healthcare Provider Perspectives.Oncology and therapy · 2026Article
- Patient Experience and Improvement Opportunities in Self-Administered, Large-Volume Subcutaneous Infusions at Home.Patient preference and adherence · 2025Article
- Subcutaneous Trastuzumab: An Observational Study of Safety and Tolerability in Patients With Early HER2-Positive Breast Cancer.International journal of breast cancer · 2024Article
- Advancing perspectives on the off-label use of anticancer drugs: an updated classification and exploration of categories.Frontiers in pharmacology · 2024Review
- Decentralized Clinical Trials in Oncology: Are We Ready for a Virtual-First Paradigm?Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023Article
- Review
- An Open-Label, Multinational, Multicenter, Phase IIIb Study with Subcutaneous Administration of Trastuzumab in Patients with HER2-Positive Early Breast Cancer to Evaluate Patient Satisfaction.European journal of breast health · 2022Article
- Results of a Dose-Finding Phase 1b Study of Subcutaneous Atezolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer.Clinical pharmacology in drug development · 2021Article
- Flexible care in breast cancer.ESMO open · 2021Review
- CD4 T-cell immune stimulation of HER2 + breast cancer cells alters response to trastuzumab in vitro.Cancer cell international · 2020Article
- Rethinking cancer clinical trials for COVID-19 and beyond.Nature cancer · 2020Article
- The smooth and bumpy road of trastuzumab administration: from intravenous (IV) in a hospital to subcutaneous (SC) at home.Facts, views & vision in ObGyn · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 10 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe subcutaneous (SC) administration of trastuzumab is highly preferred by patients. At home, administration of trastuzumab SC might further improve patient benefit. The aims of the BELIS study are to evaluate the safety and tolerability of trastuzumab SC when administered at home by a healthcare professional (HCP) and to evaluate patient-reported outcomes for treatment experience of at home cancer therapy.
methodsThis open-label phase IIIb study enrolled HER2-positive early breast cancer patients in Belgium and Israel who completed the first six cycles of trastuzumab IV (neo)adjuvant therapy. The study consisted of three consecutive treatment periods: three cycles of trastuzumab IV and SC each at the hospital and six cycles of trastuzumab SC at home.
resultsBetween November 2013 and December 2014, 23 centres enrolled 102 patients in the intent-to-treat population of which 101 patients entered the safety population. No new safety signals were detected with as expected, more mild administration site events with trastuzumab SC when compared to IV treatment. All patients agreed that they had benefit from at home administration to a large (18/81; 22%) or very large (63/81; 78%) extent. All HCPs (21/21) agreed that SC is the quickest method from start of preparation to finish of administration and that less resource use is needed.
conclusionThe results of the BELIS study support that trastuzumab SC can be safely administered at home by a HCP and all patients considered this setting as beneficial. HCPs consider the SC formulation as the quickest method to administer trastuzumab.
trial registrationEudraCT Identifier: 2013-000123-13. ClinicalTrials.gov Identifier: NCT01926886.
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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.