Early Cardiac Changes During Chemotherapy in Breast Cancer

Early Cardiac Changes During Anthracycline and/or Trastuzumab Therapy in Breast Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12611000153910

Enrollment

Registered

2011-02-09

Start date

2010-08-05

Completion date

2012-10-12

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We wish to study and determine early predictors of cardiac toxicity during combined trastuzumab and/or anthracycline chemotherapy in patients with breast cancer by way of precise assessment of sub-clinical right (RV) and LV systolic and diastolic function. Volume measurements and determination of oedema and myocardial fibrosis will be performed by CMR and advanced echocardiography in order to identify sub-clinical changes of probably significance for development of later manifest ventricular dysfunction. Secondary aim is to correlate observed cardiovascular changes with cumulative dose chemotherapy, age and pre-existing cardiovascular risk factors and biochemical markers or cardiac dysfunction and fibrosis. We hypothesise that: - CMR images will show evidence of myocardial oedema, before patients develop chemotherapy induced cardiomyopathy - tagging imaging techniques will demonstrate lowered active diastolic function - degree of cardiac dysfunction will be proportional to number of chemotherapy cycles conducted - CMR and advanced echo will allow for identification of patients at high risk of heart disease - Abnormalities seen on advanced echo and features of fibrosis on CMR will correspond with abnormal biochemical markers

Interventions

Cardiac MRI, Echocardiography, serum biomarkers at baseline, 1 month (during chemotherapy), 3 and 12 months (post chemotherapy). This will take approximately 90 minutes. We will perform these interventions to identify sub-clinical changes of probable significance for development of later manifest ventricular dysfunction.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

All patients with new diagnosis of HER2 positive early breast cancer planned for standard chemotherapy with anthracyclines and/or trastuzumab, or, patients with recurrent breast cancer planned for chemotherapy with anthracyclines and/or trastuzumab that have not had chemotherapy in the last 5 years.

Exclusion criteria

Patients with recurrent breast cancer that have received chemotherapy in the last 5 years, patients that don't meet safety requirements for cardiac MRI.

Outcome results