NT-proBNP to Assess Trastuzumab-induced Cardiotoxicity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVastra Gotaland Region
About this trial
Trastuzumab-induced cardiotoxicity (TIC) will be monitored in patients with HER2+ breast cancer undergoing trastuzumab treatment before and after breast cancer surgery. At baseline before start of trastuzumab treatment, echocardiography (ECHO)/multigated Acquisition Scan (MUGA) and measurement of plasma NT-proBNP will be performed. NT-proBNP will be measured again at 6 months and at 12 months of trastuzumab treatment. If elevations in NT-proBNP at 6 months and 12 months occur patients will be referred for ECHO/MUGA. The aim is to assess the sensitivity and specificity to detect TIC with NT-proBNP and whether ECHO/MUGA can be safely replaced by assessment of plasma NT-proBNP levels.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histological confirmed HER2 positive primary BC planned for adjuvant/neoadjuvant treatment with chemotherapy plus HER2 blocking agents.
Patients ≥18 years
ECOG/WHO 0-1
Adequate organ function for the planned treatment according to local guidelines.
Disqualifiers
Patients with previous heart disease recommended special follow-up during treatment with high risk of termination of treatment.
Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, neurological conditions, physical examination or laboratory findings) that may interfere with the planned treatment or affect patient compliance.
Pregnancy and breast feeding.
Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ).
Trial design
Design model
Single group
Treatments tested in this trial
Plasma NT-proBNP
Diagnostic testReplacement of measurement of plasma NT-proBNP instead of ECHO/MUGA at 6 months and 12 months of trastuzumab treatment to assess cardiotoxicity
Treatment groups
700 Participants
are divided into 1 treatment groupGroup A: NT-proBNP instead of ECHO/MUGA at 6 months and 12 monthsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Sensitivity and specificity of NT-proBNP to detect trastuzumab-induced cardiotoxicity
To determine the sensitivity and specificity of NT-proBNP for identification of patients that develop cardiac toxicity during treatment with HER2 blocking agents for primary breast cancer \[time frame from inclusion to 24 months after base-line investigation\]
Time frame
From inclusion to 24 months after baseline investigationSecondary outcomes
1
Prevalence of trastuzumab-induced cardiotoxicity
To determine the proportion of patients that develop cardiac toxicity during treatment with HER2 blocking agents for primary breast cancer
Time frame
From inclusion to 24 months after baseline investigation2
Anthracycline-induced change in NT-proBNP
To investigate the potential change of NT-proBNP during anthracycline-based chemotherapy in patients that receive EC followed by anti-HER2 blockade plus a taxane and whether it is correlated with the development of cardiac toxicity throughout anti-HER2 blockade. \[time frame from inclusion to 10 weeks after base-line investigation\]
Time frame
From inclusion to 10 weeks after baseline investigationSponsors and contacts
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Source ClinicalTrials.gov