Investigating the Long-term Cardiac Sequelae of Trastuzumab Therapy

NCT05019365 | Unknown

• 1 other identifier: GN19ON381
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; HER2-positive Breast Cancer; Cardiotoxicity

Keywords

Cardiotoxicity; HER2-positive Breast Cancer; Cardiac MRI

Outcome Measures

Primary Outcomes (3)

• Left Ventricular Systolic Dysfunction

  To define the prevalence of left ventricular dysfunction in patients who received trastuzumab chemotherapy at least 5 years previously

  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.

  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.

  Through study completion, on average <2years.

Other Outcomes (7)

• T1 relaxation times (global and segmental)

  Through study completion, on average <2years.

• T2 decay time (global and segmental)

  Through study completion, on average <2years.

• Extracellular volume fraction (ECV) (global and segmental)

  Through study completion, on average <2years.

Study Arms (2)

Participants with previous HER2 breast cancer

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who were treated with anthracycline and adjuvant trastuzumab chemotherapy at least 5 years previously. Age matched healthy volunteers.

You may qualify if:

• patients with HER2 positive breast cancer who received anthracycline-containing chemotherapy followed by trastuzumab at least 5 years prior to enrolment;
• age \>18 years.

You may not qualify if:

• 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.
• least 18 years (they will be matched to the study participants)
• no prior medical history (including cardiovascular health problems, medication or systemic illness)
• standard contraindication to CMR;
• suspected pregnancy

Sponsors & Collaborators

• University of Glasgow: lead
• NHS Greater Glasgow and Clyde: collaborator
• Tenovus Scotland: collaborator

Study Sites (1)

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Cardiotoxicity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Central Study Contacts

Kenneth Mangion, MD PhD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: August 24, 2021
• Study Start: March 15, 2021
• Primary Completion: May 25, 2022
• Study Completion: November 25, 2022
• Last Updated: August 24, 2021

Record last verified: 2021-08

Locations

GB (1)