Evidence map›Paper›PMID 39909533›Full record

ArticleBMJ open2025

HER-SAFE study design: an open-label, randomised controlled trial to investigate the safety of withdrawal of pharmacological treatment for recovered HER2-targeted therapy-related cardiac dysfunction.

Benjamin Dowsing, Hakim-Moulay Dehbi, Robin Chung, Joanna Pedra, Orla Worn, Jessica Artico, Peter Schmid, Rebecca Roylance, Peter Kellman, James C Moon and 9 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05880160 (Randomised Control Trial for the Safety of Withdrawal of Pharmacological Treatment for Recovered HER2 Targeted Therapy Related Cardiac Dysfunction), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

NCT05880160 naunknown statusnot on this map

Randomised Control Trial for the Safety of Withdrawal of Pharmacological Treatment for Recovered HER2 Targeted Therapy Related Cardiac Dysfunction

TypeinterventionalSponsorUniversity College, LondonRan2023 to 2025Enrolled90ConditionsCardiotoxicity, HER2-positive Breast Cancer, Heart Failure, Cancer, Therapy-RelatedArmsPhased withdrawal of heart failure medications
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Benjamin DowsingInstitute of Cardiovascular Science, University College London, London, UK.ORCID http://orcid.org/0000-0002-8877-0629
Hakim-Moulay DehbiComprehensive Clinical Trials Unit at UCL, London, UK.
Robin ChungSaint Bartholomew's Hospital Barts Heart Centre, London, UK.
Joanna PedraSaint Bartholomew's Hospital Barts Heart Centre, London, UK.
Orla WornSaint Bartholomew's Hospital Barts Heart Centre, London, UK.
Jessica ArticoInstitute of Cardiovascular Science, University College London, London, UK.
Peter SchmidQueen Mary University of London, London, UK.
Rebecca RoylanceDepartment of Oncology, UCLH Foundation Trust, London, UK.
Peter KellmanNational Heart Lung and Blood Institute, Bethesda, Maryland, USA.
James C MoonInstitute of Cardiovascular Science, University College London, London, UK.
Tom CrakeSaint Bartholomew's Hospital Barts Heart Centre, London, UK.
Mark WestwoodSaint Bartholomew's Hospital Barts Heart Centre, London, UK.
Arjun GhoshInstitute of Cardiovascular Science, University College London, London, UK.
Maria Sol AndresCardio-Oncology Centre of Excellence, Royal Brompton Hospital, London, UK.
Muhummad Sohaib NazirKing's College London School of Biomedical Engineering & Imaging Sciences, London, UK.
Alexander R LyonCardio-Oncology Centre of Excellence, Royal Brompton Hospital, London, UK.
Daniel ChenInstitute of Cardiovascular Science, University College London, London, UK.
Malcolm WalkerInstitute of Cardiovascular Science, University College London, London, UK.
Charlotte H ManistyInstitute of Cardiovascular Science, University College London, London, UK charlotte.manisty@nhs.net.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionA quarter of breast cancers show human epidermal growth factor-2 (HER2) overexpression, where targeted therapy dramatically improves survival. However, cancer therapy-related cardiac dysfunction (CTRCD) occurs in up to 15% of patients. With the interruption of HER2 therapy, if necessary, and the initiation of heart failure therapy (HFT), HER2 CTRCD recovers in over 80% of cases. The need to continue HFT in 'recovered' HER2 CTRCD following completion of HER2 therapy is unclear and there are potential significant impacts on patient's quality of life (QoL). The Randomised Controlled Trial for the Safety of Withdrawal of Pharmacological Treatment for Recovered HER2 Targeted Therapy Related Cardiac Dysfunction (HER-SAFE) aims to evaluate whether HFT can be safely withdrawn in non-high cardiovascular (CV) risk patients with 'recovered' HER2 CTRCD. METHODS AND ANALYSIS: This is a multicentre, open-label randomised controlled trial investigating whether withdrawal of HFT is non-inferior to continuation in non-high CV risk, breast cancer survivors with recovered HER2 CTRCD after cancer treatment completion. The primary endpoint is the incidence of guideline-defined cardiac dysfunction or clinical heart failure. Secondary endpoints include changes in cardiac blood biomarkers, cardiovascular magnetic resonance (CMR)-derived strain and tissue mapping and heart failure symptom questionnaires. The study will recruit 90 participants who will undergo serial clinical assessment over 12 months with advanced cardiovascular imaging (CMR scans with automated analysis at baseline, 6 and 12 months), cardiac biomarker measurement (six time points over 12 months), plus complete heart failure QoL and medication disutility questionnaires. This is the first multicentre study to address this significant clinical issue. ETHICS AND DISSEMINATION: This study was approved by the research ethics committee (London-London Bridge, 23/LO/0152). The results will be disseminated in peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: NCT05880160.

Indexed as

Breast NeoplasmsErb-b2 Receptor Tyrosine KinasesHeart FailureWithholding TreatmentCardiotoxicityFemaleHumansMulticenter Studies as TopicQuality of LifeRandomized Controlled Trials as TopicResearch DesignERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesBreast tumoursCardiovascular DiseaseCardiovascular imagingHeart failure

Identifiers

PMID39909533
PMCPMC11800297

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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.