CardiotoxicityHER-SAFENCT05880160
Safety of Withdrawal of Pharmacological Treatment for Recovered HER2 Targeted Therapy Related Cardiac Dysfunction
A study testing Phased withdrawal of heart failure medications in people with Cardiotoxicity and HER2-positive Breast Cancer, run by University College, London at 2 sites in United Kingdom.
Trial summary
Breast cancer is the most common cancer in the United Kingdom (UK), but improvements in treatment mean 3 in 4 people survive for more than 10 years. Many people receive treatments called human epidermal growth factor receptor 2 (HER2) targeted therapies for their breast cancer, however these can affect heart function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiotoxicity, HER2-positive Breast Cancer, Heart Failure
- What is being tested?
- Phased withdrawal of heart failure medications
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 14 Jul 2023to 24 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult participants (>18 years)
- A prior diagnosis of human epidermal growth factor receptor 2 (HER2)- targeted therapy related cardiac dysfunction, who currently receive standard heart failure/cardioprotective medications (any combination of angiotensin-converting enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs] and/or beta-blockers).
- Cardiac function has 'recovered'. 'Recovery' is defined as absence of heart failure symptoms with left ventricular ejection fraction (LVEF) improved to 50% or greater and N-terminal pro B-type natriuretic peptide (NTproBNP) <125ng/L, for greater than 6 months.
Who cannot join
- Advanced/ metastatic HER2 positive breast cancer requiring ongoing HER2 therapies or with life expectancy <12months.
- Patients classed as high/very high cardiovascular risk according to the International Cardio-Oncology Society (ICOS) risk stratification
- Patients with LVEF <50% prior to HER2-therapy initiation or on completion of anthracycline treatment
- Patients with ongoing indications for the cardioprotective medication - ACE inhibitors, ARBs and/or beta-blockers
- Patients with absolute contraindications to cardiovascular magnetic resonance scans (CMR).
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
St Bartholemew's Hospital
London, EC1A 7BE
University College London Hospital
London, NW1 2BU
About this study
Official title: Randomised Control Trial for the Safety of Withdrawal of Pharmacological Treatment for Recovered HER2 Targeted Therapy Related Cardiac Dysfunction
Breast cancer is the most common cancer in the United Kingdom (UK), but improvements in treatment mean 3 in 4 people survive for more than 10 years. Many people receive treatments called human epidermal growth factor receptor 2 (HER2) targeted therapies for their breast cancer, however these can affect heart function. This 'cardiotoxicity' is generally temporary and mild, but patients receive drugs to help their heart recover. Currently it is not known how long patients should receive these treatments. Patients with other types of heart failure are treated lifelong, but this may not be necessary here as the damaging cancer drugs have stopped. Taking drugs for many years can have an impact on people's quality of life, particularly for young patients. It is therefore important to understand the best treatment length. The investigators will study people whose heart function has recovered after HER2 therapy heart problems and are not at high risk for heart disease. The investigators will carefully stop their heart drugs whilst monitoring them closely with special heart scans and blood tests to detect problems early. The investigators will also study how patients are currently treated using national data. The results of this study will help doctors better guide breast cancer survivors about treatment of heart damage from HER2 cancer therapies.
Read the detailed description
Trial design: Two centre open label randomised control trial to evaluate the phased withdrawal versus continuation of heart failure treatment for 'recovered' human epidermal growth factor receptor 2 (HER2) therapy-related cardiac dysfunction in non-high risk patients following completion of HER2 therapy. The trial will include cardiovascular magnetic resonance scans (CMR) with automated in-line analytics to improve the sensitivity for detection of early relapse, and detailed patient questionnaires assessing medication disutility to better understand participant motivations and concerns related to treatment continuation and withdrawal.
Trial population: The trial will recruit 90 adult participants (>18 years) with a prior diagnosis of HER2-targeted therapy related cardiac dysfunction, who currently receive standard heart failure/ cardioprotective medications (any combination of Angiotensin-converting enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs] and/or beta-blockers), and whose cardiac function has 'recovered'. 'Recovery' is defined as absence of heart failure symptoms with left ventricular ejection fraction (LVEF) improved to 50% or greater and N-terminal pro B-type natriuretic peptide (NTproBNP) <200ng/L, for greater than 6 months. Patients will be recruited from Barts Health and University College London Hospitals (UCLH) cardio-oncology and breast cancer clinics. Exclusion criteria: Patients with advanced/ metastatic HER2 positive breast cancer requiring ongoing HER2 therapies or with life expectancy <12months will be excluded. Patients classed as high/very high cardiotoxicity risk according to the European Society of Cardiology/International Cardio-Oncology Society Position Statement (Lyon et al, 2020), LVEF <50% prior to HER2-therapies or on completion of anthracycline treatment, or indications for ongoing ACE inhibitors, ARBs and/or beta-blockers, nor those with absolute contraindications to CMR.
Interventions and Duration of treatment: Participants will undergo phased withdrawal of heart failure/ cardioprotective treatments according to a pre-specified algorithm based on the 'Withdrawal of pharmacological treatment for heart failure in patients with recovered dilated cardiomyopathy' (TRED-HF) study protocol (Halliday et al 2019). This had been designed following extensive consultation with independent experts and attempts to mimic 'real-world' medication withdrawal in clinical practice. Medications will be down titrated in a phased process every 2 weeks over a maximum of 16 weeks. Drug doses will be reduced by 50% in a stepwise manner every 2 weeks, until the patient is taking 25% or less of the maximum recommended dose at which point the medication will be stopped. Monitoring with fortnightly virtual consultations will confirm drug dose reduction and provide support. Participants will undergo clinical assessment at 6, 14 and 24 weeks and 6, 9 and 12 months with weight, blood pressure, and biomarker measurement. At baseline, 6- and 12-month visits detailed cardiovascular phenotyping using CMR and symptom and disutility questionnaires will be undertaken.
- Being tested
- Phased withdrawal of heart failure medications
- Keywords
- Cardiotoxicity, HER2-positive Breast Cancer, Heart Failure, Cancer, Therapy-Related
- Medical subject headings
- Cardiotoxicity, Heart Failure, Neoplasms, Second Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phased withdrawal of heart failure medicationsOther
As per arm/group description
| Study group | Role | What they receive |
|---|---|---|
| Treatment Withdrawal | Experimental | Participants will undergo phased withdrawal of heart failure/ cardioprotective treatments according to a pre-specified algorithm based on the 'Withdrawal of pharmacological treatment for heart failure in patients with recovered dilated cardiomyopathy' (TRED-HF) study protocol (Halliday et al 2019). Medications will be down titrated in a phased process every 2 weeks over 16 weeks maximum. Drug doses will be reduced by 50% every 2 weeks, until the patient is taking 25% or less of the maximum recommended dose at which point they will be stopped. Monitoring with fortnightly virtual consultations will confirm dose reduction and provide support. Participants will undergo clinical assessment at 6, 14 and 24 weeks and 6, 9 and 12 months with weight, blood pressure, and biomarker measurement. At baseline, 6- and 12-month visits detailed cardiovascular phenotyping using cardiovascular magnetic resonance scans and symptom and disutility questionnaires will be undertaken. Receives: Other: Phased withdrawal of heart failure medications |
| Treatment Continuation | No intervention | Participants will continue their current heart failure/ cardioprotective treatments. Participants will undergo clinical assessment at 6, 14 and 24 weeks and 6, 9 and 12 months with weight, blood pressure, and biomarker measurement. At baseline, 6- and 12-month visits detailed cardiovascular phenotyping using cardiovascular magnetic resonance scans and symptom and disutility questionnaires will be undertaken. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse in Cardiotoxicity
Number of participants with relapse in cardiotoxicity, defined based on International Cardio-Oncology Society 2021 Guidelines as (at least one of):
- Asymptomatic left ventricular ejection fraction (LVEF) reduction by ≥10 percentage points to a LVEF of <50%
- Asymptomatic LVEF reduction by ≥5 percentage points to an LVEF of <50% plus new relative decline in global longitudinal strain (GLS) by >15% from baseline AND/OR new rise in cardiac biomarkers (>2 fold increase in N-terminal pro B-type natriuretic peptide [NTproBNP] to >400ng/L, or high sensitivity Troponin >99th percentile)
- Clinical heart failure (based on symptoms and clinical examination) with at least one of the following: fall in LVEF ≥5%, increase in cardiac biomarkers (as above), relative fall in GLS > 15%, new arrhythmia (excluding ectopy)
Measured: 12 months
Secondary outcomes (11)
Cardiac Biomarkers (N-terminal pro B-type natriuretic peptide [NT-proBNP])
Change from baseline at 6 and 12 months in the cardiac biomarker NT-proBNP (measured in pg/L)
Measured: 12 months
Cardiac Biomarkers (Troponin T)
Change from baseline at 6 and 12 months in the cardiac biomarkers Troponin T (measured in ng/L).
Measured: 12 months
Quality of life (Kansas City Cardiomyopathy Questionnaire)
Change from baseline at 6 and 12 months in the quality of life questionnaire score - the Kansas City Cardiomyopathy Questionnaire (Minimum 0 - Maximum 100; 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent).
Measured: 12 months
Quality of life (Minnesota Living with Heart Failure Questionnaire)
Change from baseline at 6 and 12 months in quality of life questionnaire score - the Minnesota Living with Heart Failure Questionnaire (Minimum 0 - Maximum 105, Higher score indicates worse outcome).
Measured: 12 months
Heart rate
Change from baseline at 6 and 12 months in baseline resting heart rate (beats per minute)
Measured: 12 months
Blood Pressure
Change from baseline at 6 and 12 months in blood pressure (Systolic and diastolic, mmHg)
Measured: 12 months
Left Ventricular Volumes (By Cardiac MRI)
Change from baseline at 6 and 12 months in CMR-derived left ventricular volumes (measured in ml and ml/m2)
Measured: 12 months
Left Ventricular Ejection Fraction (By Cardiac MRI)
Change from baseline at 6 and 12 months in CMR-derived left ventricular ejection fraction (measured in %)
Measured: 12 months
Left Ventricular Strain (By Cardiac MRI)
Change from baseline at 6 and 12 months in CMR-derived left ventricular strain (measured in %)
Measured: 12 months
T1 mapping (By Cardiac MRI)
Change from baseline at 6 and 12 months in CMR-derived native T1 mapping (measured in ms)
Measured: 12 months
Medication Disutility
Medication disutility is the inconvenience to the patient of taking a given medication. This will be assessed with a structured questionnaire with qualitative responses regarding medication side effects, cost (financial and personal) and the benefits required to offset this.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start14 Jul 2023
- Primary completion24 Jun 2026
- Study completion24 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CardiotoxicityStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two centre open label randomised controlled trial to evaluate the phased withdrawal versus continuation of heart failure treatment for 'recovered' human epidermal growth factor receptor 2 (HER2) therapy-related cardiac dysfunction in non-high risk patients following completion of HER2 therapy.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation, University College London Hospitals, Royal Brompton & Harefield NHS Foundation Trust, Imperial College Healthcare NHS Trust, The Whittington Hospital NHS Trust, Barts & The London NHS Trust
- Responsible party
- Sponsor
- Investigators
- Charlotte Manisty, Principal investigator, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880160
- Sponsor's protocol ID
- 147133
- Other IDs
- FS/CRTF/22/24395, 312432
- Acronym
- HER-SAFE
- Status last verified
- Sep 2026
- First submitted
- 8 Feb 2023
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dowsing B, Dehbi HM, Chung R, Pedra J, Worn O, Artico J, Schmid P, Roylance R, Kellman P, Moon JC, Crake T, Westwood M, Ghosh A, Andres MS, Nazir MS, Lyon AR, Chen D, Walker M, Manisty CH. 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. BMJ Open. 2025 Feb 5;15(2):e091917. doi: 10.1136/bmjopen-2024-091917.
PubMed 39909533
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Control Trial for the Safety of Withdrawal of Pharmacological Treatment for Recovered HER2 Targeted Therapy Related Cardiac Dysfunction
- ClinicalTrials.gov ID
- NCT05880160
- Acronym / sponsor ID
- HER-SAFE / 147133
- Keywords
- Cardiotoxicity, HER2-positive Breast Cancer, Heart Failure, Cancer, Therapy-Related
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- British Heart Foundation, University College London Hospitals, Royal Brompton & Harefield NHS Foundation Trust, Imperial College Healthcare NHS Trust, The Whittington Hospital NHS Trust, Barts & The London NHS Trust
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- 24 Jun 2026 (actual)
- Study completion
- 24 Jun 2026 (actual)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast cancer is the most common cancer in the United Kingdom (UK), but improvements in treatment mean 3 in 4 people survive for more than 10 years. Many people receive treatments called human epidermal growth factor receptor 2 (HER2) targeted therapies for their breast cancer, however these can affect heart function. This 'cardiotoxicity' is generally temporary and mild, but patients receive drugs to help their heart recover. Currently it is not known how long patients should receive these treatments. Patients with other types of heart failure are treated lifelong, but this may not be necessary here as the damaging cancer drugs have stopped. Taking drugs for many years can have an impact on people's quality of life, particularly for young patients. It is therefore important to understand the best treatment length. The investigators will study people whose heart function has recovered after HER2 therapy heart problems and are not at high risk for heart disease. The investigators will carefully stop their heart drugs whilst monitoring them closely with special heart scans and blood tests to detect problems early. The investigators will also study how patients are currently treated using national data. The results of this study will help doctors better guide breast cancer survivors about treatment of heart damage from HER2 cancer therapies.
Detailed description
Trial design: Two centre open label randomised control trial to evaluate the phased withdrawal versus continuation of heart failure treatment for 'recovered' human epidermal growth factor receptor 2 (HER2) therapy-related cardiac dysfunction in non-high risk patients following completion of HER2 therapy. The trial will include cardiovascular magnetic resonance scans (CMR) with automated in-line analytics to improve the sensitivity for detection of early relapse, and detailed patient questionnaires assessing medication disutility to better understand participant motivations and concerns related to treatment continuation and withdrawal.
Trial population: The trial will recruit 90 adult participants (>18 years) with a prior diagnosis of HER2-targeted therapy related cardiac dysfunction, who currently receive standard heart failure/ cardioprotective medications (any combination of Angiotensin-converting enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs] and/or beta-blockers), and whose cardiac function has 'recovered'. 'Recovery' is defined as absence of heart failure symptoms with left ventricular ejection fraction (LVEF) improved to 50% or greater and N-terminal pro B-type natriuretic peptide (NTproBNP) <200ng/L, for greater than 6 months. Patients will be recruited from Barts Health and University College London Hospitals (UCLH) cardio-oncology and breast cancer clinics. Exclusion criteria: Patients with advanced/ metastatic HER2 positive breast cancer requiring ongoing HER2 therapies or with life expectancy <12months will be excluded. Patients classed as high/very high cardiotoxicity risk according to the European Society of Cardiology/International Cardio-Oncology Society Position Statement (Lyon et al, 2020), LVEF <50% prior to HER2-therapies or on completion of anthracycline treatment, or indications for ongoing ACE inhibitors, ARBs and/or beta-blockers, nor those with absolute contraindications to CMR.
Interventions and Duration of treatment: Participants will undergo phased withdrawal of heart failure/ cardioprotective treatments according to a pre-specified algorithm based on the 'Withdrawal of pharmacological treatment for heart failure in patients with recovered dilated cardiomyopathy' (TRED-HF) study protocol (Halliday et al 2019). This had been designed following extensive consultation with independent experts and attempts to mimic 'real-world' medication withdrawal in clinical practice. Medications will be down titrated in a phased process every 2 weeks over a maximum of 16 weeks. Drug doses will be reduced by 50% in a stepwise manner every 2 weeks, until the patient is taking 25% or less of the maximum recommended dose at which point the medication will be stopped. Monitoring with fortnightly virtual consultations will confirm drug dose reduction and provide support. Participants will undergo clinical assessment at 6, 14 and 24 weeks and 6, 9 and 12 months with weight, blood pressure, and biomarker measurement. At baseline, 6- and 12-month visits detailed cardiovascular phenotyping using CMR and symptom and disutility questionnaires will be undertaken.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two centre open label randomised controlled trial to evaluate the phased withdrawal versus continuation of heart failure treatment for 'recovered' human epidermal growth factor receptor 2 (HER2) therapy-related cardiac dysfunction in non-high risk patients following completion of HER2 therapy.
| Arm | Type | Receives |
|---|---|---|
| Treatment Withdrawal | Experimental | Other: Phased withdrawal of heart failure medicationsParticipants will undergo phased withdrawal of heart failure/ cardioprotective treatments according to a pre-specified algorithm based on the 'Withdrawal of pharmacological treatment for heart failure in patients with recovered dilated cardiomyopathy' (TRED-HF) study protocol (Halliday et al 2019). Medications will be down titrated in a phased process every 2 weeks over 16 weeks maximum. Drug doses will be reduced by 50% every 2 weeks, until the patient is taking 25% or less of the maximum recommended dose at which point they will be stopped. Monitoring with fortnightly virtual consultations will confirm dose reduction and provide support. Participants will undergo clinical assessment at 6, 14 and 24 weeks and 6, 9 and 12 months with weight, blood pressure, and biomarker measurement. At baseline, 6- and 12-month visits detailed cardiovascular phenotyping using cardiovascular magnetic resonance scans and symptom and disutility questionnaires will be undertaken. |
| Treatment Continuation | No intervention | –Participants will continue their current heart failure/ cardioprotective treatments. Participants will undergo clinical assessment at 6, 14 and 24 weeks and 6, 9 and 12 months with weight, blood pressure, and biomarker measurement. At baseline, 6- and 12-month visits detailed cardiovascular phenotyping using cardiovascular magnetic resonance scans and symptom and disutility questionnaires will be undertaken. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult participants (>18 years)
- A prior diagnosis of human epidermal growth factor receptor 2 (HER2)- targeted therapy related cardiac dysfunction, who currently receive standard heart failure/cardioprotective medications (any combination of angiotensin-converting enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs] and/or beta-blockers).
- Cardiac function has 'recovered'. 'Recovery' is defined as absence of heart failure symptoms with left ventricular ejection fraction (LVEF) improved to 50% or greater and N-terminal pro B-type natriuretic peptide (NTproBNP) <125ng/L, for greater than 6 months.
Key exclusion criteria (5 listed)
- Advanced/ metastatic HER2 positive breast cancer requiring ongoing HER2 therapies or with life expectancy <12months.
- Patients classed as high/very high cardiovascular risk according to the International Cardio-Oncology Society (ICOS) risk stratification
- Patients with LVEF <50% prior to HER2-therapy initiation or on completion of anthracycline treatment
- Patients with ongoing indications for the cardioprotective medication - ACE inhibitors, ARBs and/or beta-blockers
- Patients with absolute contraindications to cardiovascular magnetic resonance scans (CMR).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phased withdrawal of heart failure medicationsAs per arm/group description | Other | Treatment Withdrawal |
Primary outcome
Relapse in Cardiotoxicity
Time frame: 12 months
Number of participants with relapse in cardiotoxicity, defined based on International Cardio-Oncology Society 2021 Guidelines as (at least one of): 1. Asymptomatic left ventricular ejection fraction (LVEF) reduction by ≥10 percentage points to a LVEF of <50% 2. Asymptomatic LVEF reduction by ≥5 percentage points to an LVEF of <50% plus new relative decline in global longitudinal strain (GLS) by >15% from baseline AND/OR new rise in cardiac biomarkers (>2 fold increase in N-terminal pro B-type natriuretic peptide [NTproBNP] to >400ng/L, or high sensitivity Troponin >99th percentile) 3. Clinical heart failure (based on symptoms and clinical examination) with at least one of the following: fall in LVEF ≥5%, increase in cardiac biomarkers (as above), relative fall in GLS > 15%, new arrhythmia (excluding ectopy)
11 secondary outcomes
Cardiac Biomarkers (N-terminal pro B-type natriuretic peptide [NT-proBNP])
Time frame: 12 months
Cardiac Biomarkers (Troponin T)
Time frame: 12 months
Quality of life (Kansas City Cardiomyopathy Questionnaire)
Time frame: 12 months
Quality of life (Minnesota Living with Heart Failure Questionnaire)
Time frame: 12 months
Heart rate
Time frame: 12 months
Blood Pressure
Time frame: 12 months
Left Ventricular Volumes (By Cardiac MRI)
Time frame: 12 months
Left Ventricular Ejection Fraction (By Cardiac MRI)
Time frame: 12 months
Left Ventricular Strain (By Cardiac MRI)
Time frame: 12 months
T1 mapping (By Cardiac MRI)
Time frame: 12 months
Medication Disutility
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Derived from this study: PubMed 39909533Dowsing B, Dehbi HM, Chung R, Pedra J, Worn O, Artico J, Schmid P, Roylance R, Kellman P, Moon JC, Crake T, Westwood M, Ghosh A, Andres MS, Nazir MS, Lyon AR, Chen D, Walker M, Manisty CH. 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. BMJ Open. 2025 Feb 5;15(2):e091917. doi: 10.1136/bmjopen-2024-091917.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte Manisty principal investigator
UCL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phased withdrawal of heart failure medications in people with Cardiotoxicity and HER2-positive Breast Cancer, run by University College, London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse in Cardiotoxicity (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05880160, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.