This study aims to assess early cardiac damage by means of GLS in newly diagnosed BC patients treated with anthracycline-based chemotherapy, and to investigate whether myocardial damage as measured with T1 / T2 CMR mapping and plasma hs-Troponin T…
ID
Source
Brief title
Condition
- Myocardial disorders
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A relative reduction in GLS from baseline to 2 weeks (+/- 1 week) after
chemotherapy discontinuation.
Secondary outcome
Changes in circulating cardiac biomarkers (hs-Troponin T and NT-proBNP)
compared with baseline, measured every 3 weeks before and after each
chemotherapy cycle. The endpoint is a clinically significant increase in each
biomarker above the normal value ranges between time points. Quality of Life
(PROMs) will be evaluated after 1 and 3 years.
Background summary
The number of breast cancer (BC) survivors has increased rapidly due to
impressive achievements in breast cancer screening and treatment. The downside
of this increased survival is a growing population of cancer patients with
chemotherapy-related cardiovascular morbidity and mortality, in particular
heart failure. Chemotherapy induced cardiomyopathy was traditionally considered
to have a poor prognosis and often refractory to any heart failure treatment.
Recent studies however, have suggested that reduction in left ventricular
ejection fraction (LVEF) can be mitigated when cardiotoxicity is detected in an
early stage and timely intervened. Early detection of chemotherapy induced
cardiotoxicity is therefore mandatory to further boost prognosis of breast
cancer patients. CMR is the gold standard technique for anatomical and
functional evaluation of the heart. Evaluation of global longitudinal strain
(GLS) is the most reproducible technique used to measure early left ventricular
impairment. Moreover, with CMR multi-parametric techniques such as T1 and T2
mapping allow accurate characterization of myocardial tissue. Early detection
of cardiac damage prior to cardiac function loss would improve risk
stratification and has important therapeutic consequences.
Study objective
This study aims to assess early cardiac damage by means of GLS in newly
diagnosed BC patients treated with anthracycline-based chemotherapy, and to
investigate whether myocardial damage as measured with T1 / T2 CMR mapping and
plasma hs-Troponin T is related to changes in GLS.
Study design
A prospective observational study, with female breast cancer patients receiving
anthracycline-based chemotherapy with an intermediate, high or very high
cardiotoxicity risk will be performed.
Study burden and risks
Study participation has minimal risk for patients. CMR and echocardiography
have minimal risks and are merely an addition to clinical treatment. Discomfort
may be caused by the peripheral venous catheter for contrast infusion during
CMR and for blood samples collection. Possible side effects from blood sample
collection includes faintness, inflammation of the vein, pain, bruising, or
bleeding at the site of puncture. Blood sample collection timepoints are
scheduled to coincide with local standard care protocol. The benefit of study
participation is the monitoring of cardiac function after chemotherapy
treatment, which could lead to early treatment initiation if chemotherapy
related cardiac dysfunction is determined.
Geert Grooteplein 10
Nijmegen 6500HB
NL
Geert Grooteplein 10
Nijmegen 6500HB
NL
Listed location countries
Age
Inclusion criteria
Women diagnosed with primary breast cancer receiving (neo-) adjuvant
chemotherapy
Increased cardiotoxicity risk (intermediate, high, very high risk)
Age * 18 years
Exclusion criteria
Cancer recurrence
Cancer metastasis
History of myocardial infarction or heart failure
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL70268.091.19 |