Breast CancerNCT05019365
Investigating the Long-term Cardiac Sequelae of Trastuzumab Therapy
An observational study of Breast Cancer and HER2-positive Breast Cancer, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
The introduction of trastuzumab for the treatment of patients with human epidermal growth factor receptor 2 (HER2) positive breast cancer has had a major impact upon cancer outcomes. However, cardiac toxicity remains a substantial concern. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, HER2-positive Breast Cancer, Cardiotoxicity
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Mar 2021to 25 Nov 2022
- Phase
- Observational
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who were treated with anthracycline and adjuvant trastuzumab chemotherapy at least 5 years previously. Age matched healthy volunteers.
Who may be able to join
- patients with HER2 positive breast cancer who received anthracycline-containing chemotherapy followed by trastuzumab at least 5 years prior to enrolment;
- age >18 years.
- least 18 years (they will be matched to the study participants)
- no prior medical history (including cardiovascular health problems, medication or systemic illness)
Who cannot join
- standard contraindication to CMR (ex: pacemaker, metallic implant);
- pregnancy;
- eGFR <30 ml/min/1.73 m2) past medical history of heart failure or left ventricular systolic dysfunction.
- Healthy Volunteers:
- Twenty age and sex matched healthy volunteers will undergo a similar CMR protocol.
- standard contraindication to CMR;
- suspected pregnancy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Beatson West of Scotland Cancer Centre
Glasgow
Kenneth Mangion, MD PhD, kenneth.mangion@ggc.scot.nhs.uk
About this study
The introduction of trastuzumab for the treatment of patients with human epidermal growth factor receptor 2 (HER2) positive breast cancer has had a major impact upon cancer outcomes. However, cardiac toxicity remains a substantial concern. Conventionally, this toxicity has been considered as a transient and reversible phenomenon occurring in the immediate peri-treatment period in around 20% of patients. Current guidelines recommend monitoring heart function during treatment and at completion. Recent registry data suggest that trastuzumab-related cardiotoxicity may also manifest in the longer-term. The nature and longer-term prevalence of left ventricular dysfunction with HER2 positive breast cancer treated with trastuzumab is unclear. The aim of this project is to define the prevalence of left ventricular dysfunction late after completion of trastuzumab therapy.
Read the detailed description
In 2014, there were 45,535 cases of breast cancer diagnosed in England and Wales(1). Predicted 10-year survival in 2015, from data by the National Statistics office was estimated at 81%(2). Breast cancer is the most common malignancy in Scotland and the second most common cause of death(3). Around 1 in 4 of these cancers overexpress human epidermal growth factor receptor 2 (HER2). For these patients, trastuzumab is a recommended and highly effective component of a chemotherapy regime that usually includes an anthracycline(4).
Up to a quarter of patients treated with trastuzumab will develop cardiac dysfunction(5-7), conventionally defined as an asymptomatic >10% fall in left ventricular ejection fraction (LVEF) to an absolute LVEF <50%, or symptomatic heart failure(8). The risk is greater in patients who have received prior anthracyclines(9). Trastuzumab-related cardiotoxicity has, typically been considered to be a reversible phenomenon which recovers with interruption or cessation of treatment(10-14). The long-term benefit of cardioprotective treatment with angiotensin converting enzyme inhibitors or beta blockers when cardiotoxicity is detected is unclear(8) and these agents are often either not continued or not be prescribed at all.
The incidence of cardiac dysfunction or heart failure in the longer-term is not well-defined (12,14-20) . Clinical trials, which have excluded patients with baseline cardiovascular comorbidity, report no excess of cardiovascular events after the first two years(21-23) but observational studies report a much higher incidence of up to 23.8%(9,24). A landmark analysis of patients with a history of breast cancer (median follow-up 9 years) reported that patients treated with anthracycline chemotherapy and trastuzumab were three-fold more likely to develop heart failure than those treated with anthracycline alone. Importantly, these data were derived from a population censored at one year and reflect 'late' manifestations of cardiotoxicity rather than ongoing symptoms from an early diagnosis(25). This important study reported the incidence of symptomatic heart failure and not LV dysfunction which would be expected to be substantially more prevalent(26). Furthermore, the long-term implications of an apparently transient drop in LVEF during treatment are unclear.
Cardiovascular magnetic resonance (CMR) is the gold standard for the assessment of LV function(27). Previous work has demonstrated that CMR may be better able to identify small changes in LVEF related to chemotherapeutic agents(18,28,29). CMR has superior accuracy and precision when compared with echocardiography and allows myocardial tissue characterisation(30,31). My proposed CMR protocol will generate important insights into the long-term cardiac effects of trastuzumab and further novelty will be provided by the incorporation of tissue mapping methods(32) and LV strain assessment(33,34). Via collaboration with mathematicians I will also derive computational models.
- Conditions
- Breast Cancer, HER2-positive Breast Cancer, Cardiotoxicity
- Keywords
- Cardiotoxicity, HER2-positive Breast Cancer, Cardiac MRI
- Medical subject headings
- Breast Neoplasms, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with previous HER2 breast cancer | Not described | |
| Healthy Volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Systolic Dysfunction
To define the prevalence of left ventricular dysfunction in patients who received trastuzumab chemotherapy at least 5 years previously
Measured: Through study completion, on average <2years.
Reduced Global Longitudinal Strain (global and segmental)
GLS less than 2 standard deviations from normal reference range, using Displacement Encoding with Stimulated Echoes (DENSE) MRI.
Measured: Through study completion, on average <2years.
Reduced Circumferential Strain (global and segmental)
GCS less than 2 standard deviations from normal reference range, using Displacement Encoding with Stimulated Echoes (DENSE) MRI.
Measured: Through study completion, on average <2years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start15 Mar 2021
- Primary completion25 May 2022 (estimated)
- Study completion25 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde, Tenovus Scotland
- Responsible party
- Principal investigator, Kenneth Mangion, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019365
- Sponsor's protocol ID
- GN19ON381
- Status last verified
- Aug 2021
- First submitted
- 24 Nov 2020
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing will be on reasonable request to CI.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Long-term Cardiac Sequelae of Trastuzumab Therapy
- ClinicalTrials.gov ID
- NCT05019365
- Acronym / sponsor ID
- GN19ON381
- Conditions
- Breast Cancer, HER2-positive Breast Cancer, Cardiotoxicity
- Keywords
- Cardiotoxicity, HER2-positive Breast Cancer, Cardiac MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde, Tenovus Scotland
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 25 May 2022 (estimated)
- Study completion
- 25 Nov 2022 (estimated)
- First posted
- 24 Aug 2021 (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.
The introduction of trastuzumab for the treatment of patients with human epidermal growth factor receptor 2 (HER2) positive breast cancer has had a major impact upon cancer outcomes. However, cardiac toxicity remains a substantial concern. Conventionally, this toxicity has been considered as a transient and reversible phenomenon occurring in the immediate peri-treatment period in around 20% of patients. Current guidelines recommend monitoring heart function during treatment and at completion. Recent registry data suggest that trastuzumab-related cardiotoxicity may also manifest in the longer-term. The nature and longer-term prevalence of left ventricular dysfunction with HER2 positive breast cancer treated with trastuzumab is unclear. The aim of this project is to define the prevalence of left ventricular dysfunction late after completion of trastuzumab therapy.
Detailed description
In 2014, there were 45,535 cases of breast cancer diagnosed in England and Wales(1). Predicted 10-year survival in 2015, from data by the National Statistics office was estimated at 81%(2). Breast cancer is the most common malignancy in Scotland and the second most common cause of death(3). Around 1 in 4 of these cancers overexpress human epidermal growth factor receptor 2 (HER2). For these patients, trastuzumab is a recommended and highly effective component of a chemotherapy regime that usually includes an anthracycline(4).
Up to a quarter of patients treated with trastuzumab will develop cardiac dysfunction(5-7), conventionally defined as an asymptomatic >10% fall in left ventricular ejection fraction (LVEF) to an absolute LVEF <50%, or symptomatic heart failure(8). The risk is greater in patients who have received prior anthracyclines(9). Trastuzumab-related cardiotoxicity has, typically been considered to be a reversible phenomenon which recovers with interruption or cessation of treatment(10-14). The long-term benefit of cardioprotective treatment with angiotensin converting enzyme inhibitors or beta blockers when cardiotoxicity is detected is unclear(8) and these agents are often either not continued or not be prescribed at all.
The incidence of cardiac dysfunction or heart failure in the longer-term is not well-defined (12,14-20) . Clinical trials, which have excluded patients with baseline cardiovascular comorbidity, report no excess of cardiovascular events after the first two years(21-23) but observational studies report a much higher incidence of up to 23.8%(9,24). A landmark analysis of patients with a history of breast cancer (median follow-up 9 years) reported that patients treated with anthracycline chemotherapy and trastuzumab were three-fold more likely to develop heart failure than those treated with anthracycline alone. Importantly, these data were derived from a population censored at one year and reflect 'late' manifestations of cardiotoxicity rather than ongoing symptoms from an early diagnosis(25). This important study reported the incidence of symptomatic heart failure and not LV dysfunction which would be expected to be substantially more prevalent(26). Furthermore, the long-term implications of an apparently transient drop in LVEF during treatment are unclear.
Cardiovascular magnetic resonance (CMR) is the gold standard for the assessment of LV function(27). Previous work has demonstrated that CMR may be better able to identify small changes in LVEF related to chemotherapeutic agents(18,28,29). CMR has superior accuracy and precision when compared with echocardiography and allows myocardial tissue characterisation(30,31). My proposed CMR protocol will generate important insights into the long-term cardiac effects of trastuzumab and further novelty will be provided by the incorporation of tissue mapping methods(32) and LV strain assessment(33,34). Via collaboration with mathematicians I will also derive computational models.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with previous HER2 breast cancer | – | – |
| Healthy Volunteers | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were treated with anthracycline and adjuvant trastuzumab chemotherapy at least 5 years previously. Age matched healthy volunteers.
Key inclusion criteria (4 listed)
- patients with HER2 positive breast cancer who received anthracycline-containing chemotherapy followed by trastuzumab at least 5 years prior to enrolment;
- age >18 years.
- least 18 years (they will be matched to the study participants)
- no prior medical history (including cardiovascular health problems, medication or systemic illness)
Key exclusion criteria (7 listed)
- standard contraindication to CMR (ex: pacemaker, metallic implant);
- pregnancy;
- eGFR <30 ml/min/1.73 m2) past medical history of heart failure or left ventricular systolic dysfunction.
- Twenty age and sex matched healthy volunteers will undergo a similar CMR protocol.
- standard contraindication to CMR;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Left Ventricular Systolic Dysfunction
Time frame: Through study completion, on average <2years.
To define the prevalence of left ventricular dysfunction in patients who received trastuzumab chemotherapy at least 5 years previously
Reduced Global Longitudinal Strain (global and segmental)
Time frame: Through study completion, on average <2years.
GLS less than 2 standard deviations from normal reference range, using Displacement Encoding with Stimulated Echoes (DENSE) MRI.
Reduced Circumferential Strain (global and segmental)
Time frame: Through study completion, on average <2years.
GCS less than 2 standard deviations from normal reference range, using Displacement Encoding with Stimulated Echoes (DENSE) MRI.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Individual participant dataSharing planned: Undecided. Data sharing will be on reasonable request to CI.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and HER2-positive Breast Cancer, run by University of Glasgow at 1 site 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kenneth Mangion, MD PhD (0141 232 7600, kenneth.mangion@ggc.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular Systolic Dysfunction (time frame: Through study completion, on average <2years.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2021.