NT-proBNP to Assess Trastuzumab-induced Cardiotoxicity
Recruiting · NCT06340516 · Interventional (participants receive a specific treatment) · Lead sponsor: Vastra Gotaland Region
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
- No distant metastasis (CT/MRI only if clinically indicated).
- Negative pregnancy test within 14 days prior to start of treatment.
- If of childbearing potential, willing to use an effective form of contraception.
- No other malignancy during the last 5 years except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix.
- Signed informed consent and willingness to follow the trial procedures.
Exclusion criteria
- 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).
Where it is running
1 location listed.
- Jubileumskliniken, Sahlgrenska University Hospital - Gothenburg, Sweden