Actively Recruiting
NT-proBNP to Assess Trastuzumab-induced Cardiotoxicity
Led by Vastra Gotaland Region · Updated on 2024-04-01
700
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
NT-proBNP to Assess Trastuzumab-induced Cardiotoxicity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed HER2 positive primary breast cancer planned for adjuvant or neoadjuvant chemotherapy plus HER2 blocking agents
- Patients aged 18 years or older
- ECOG/WHO performance status 0-1
- Adequate organ function as required for planned treatment
- No distant metastasis (CT/MRI only if clinically indicated)
- Negative pregnancy test within 14 days before starting treatment
- Willing to use effective contraception if of childbearing potential
- No other malignancies in the last 5 years except treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- Signed informed consent and willingness to follow trial procedures
You will not qualify if you...
- Previous heart disease requiring special follow-up during treatment with high risk of treatment termination
- Any other medical condition (psychiatric illness, infectious diseases, neurological conditions, abnormal physical or laboratory findings) that may interfere with treatment or compliance
- Pregnancy or breastfeeding
- Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Jubileumskliniken, Sahlgrenska University Hospital
Gothenburg, Sweden, 432 45
Actively Recruiting
Research Team
D
Daniel Giglio, Assoc Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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