Table 3.

Ongoing trials of cardiotoxicity monitoring and management

Trial	Population	Cohorts	Outcomes/endpoints	Status
COBC (NCT02571894)	Women with newly diagnosed BC receiving (neo)adjuvant CT ± TRAS N ≈ 320	Standard oncological follow-up vs standard oncological follow-up plus surveillance and treatment for subclinical cardiotoxicity	• Primary: cumulative incidence of cardiotoxicity at 1-year post-CT • Secondary: number of cardiotoxic events at 5 and 10 years post-CT; overall survival, biomarker (hs-TnT and BNP) and imaging results, and quality of life result at 1, 5, and 10 years post-CT	Active, not recruiting; estimated primary completion February 2020
EMBRACE-MRI (NCT02306538)	Women with HER2+ early BC receiving TRAS + CT (no prior treatment with anthracycline) N ≈ 136	All patients undergo cardiac MRI pre-treatment, after anthracycline treatment, during TRAS treatment, and at the end of all therapy	• Primary: incidence of myocardial edema with or without conventionally defined cardiotoxicity • Secondary: incidence of myocardial edema with or without ≥ 5% LVEF decrease	Recruitment ongoing; estimated primary completion October 2019
CCT (NCT01173341)	Women with HER2+ BC receiving chemotherapy ± TRAS N ≈ 625	Patients will receive ECG and blood draw, by patient treatment group (TRAS only, CT only, TRAS + CT)	• Primary: incidence of cardiac dysfunction or signs or symptoms of heart failure • Secondary: Incidence of LVEF change	Recruitment ongoing, estimated primary completion April 2029
TITAN (NCT01621659)	Patients with BC or lymphoma scheduled to receive anthracyclines and/or TRAS N ≈ 282	Patients will receive usual care or regular assessment and treatment by a multidisciplinary team	• Primary: ECG change from baseline to 1 year • Secondary: serum biomarker change from baseline to 1 year	Active, not recruiting; estimated completion May 2019
EACVI/HFA COT Registry	BC patients undergoing treatment with an agent with a known potential of cardiac toxicity and cardiac monitoring	All patients are observed at baseline and for 12 months (5-year follow-up planned)	• Examine clinical, imaging, and treatment practices for anti-BC drug-related cardiotoxicity in Europe	Ongoing; established in 2015

BC breast cancer, BNP B-type natriuretic peptide, CT chemotherapy, ECG electrocardiogram, HER2+ human epidermal growth factor receptor-2-positive, LVEF left ventricular ejection fraction, MRI magnetic resonance imaging, TRAS trastuzumab, TnT troponin T