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
Qualifiers
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
Treatments tested in this trial
- Plasma NT-proBNP
Treatment groups
700 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov