UnknownNot Applicable

Investigating the Long-term Cardiac Sequelae of Trastuzumab Therapy

United Kingdom60 participantsStarted 2021-03-15

Plain-language 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. 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * patients with HER2 positive breast cancer who received anthracycline-containing chemotherapy followed by trastuzumab at least 5 years prior to enrolment; * age \>18 years. Exclusion Criteria: * 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. Inclusion Criteria: * least 18 years (they will be matched to the study participants) * no prior medical history (including cardiovascular health problems, medication or systemic illness) Exclusion Criteria: * standard contraindication to CMR; * suspected pregnancy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Left Ventricular Systolic Dysfunction

Timeframe: Through study completion, on average <2years.

Reduced Global Longitudinal Strain (global and segmental)

Timeframe: Through study completion, on average <2years.

Reduced Circumferential Strain (global and segmental)

Timeframe: Through study completion, on average <2years.

Trial details

NCT IDNCT05019365

SponsorUniversity of Glasgow

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-05-25

Contact for this trial

Kenneth Mangion, MD PhD

0141 232 7600 kenneth.mangion@ggc.scot.nhs.uk

View on ClinicalTrials.gov More Breast Cancer trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Left Ventricular Systolic Dysfunction

Timeframe: Through study completion, on average <2years.

Reduced Global Longitudinal Strain (global and segmental)

Timeframe: Through study completion, on average <2years.

Reduced Circumferential Strain (global and segmental)

Timeframe: Through study completion, on average <2years.