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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Kenneth Mangion, MD PhD contact

0141 232 7600

kenneth.mangion@ggc.scot.nhs.uk

United Kingdom1 site, 1 recruiting
  • Beatson West of Scotland Cancer Centre

    Glasgow

    Kenneth Mangion, MD PhD, kenneth.mangion@ggc.scot.nhs.uk

    Recruiting

Other trials in United Kingdom

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.

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 groups in NCT05019365
Study groupRoleWhat they receive
Participants with previous HER2 breast cancerNot described
Healthy VolunteersNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  2. 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.

  3. 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.

  1. First posted24 Aug 2021
  2. Study start15 Mar 2021
  3. Primary completion25 May 2022 (estimated)
  4. Study completion25 Nov 2022 (estimated)

Resources

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)
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.

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.

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