Actively Recruiting
Monitoring Heart Function Through Blood Test Analysis of NT-proBNP During Treatment With HER2-Targeted Antibodies in HER2-Positive Breast Cancer - A Swedish Multicenter Study
Led by Vastra Gotaland Region · Updated on 2024-04-01
700
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating trastuzumab-induced cardiotoxicity (TIC) in patients with HER2-positive breast cancer who are receiving trastuzumab treatment before and after breast cancer surgery. The study aims to assess how well blood levels of NT-proBNP can detect TIC compared to the current standard heart function tests, echocardiography (ECHO) and Multigated Acquisition Scan (MUGA). This national multicenter phase II trial focuses on patients planned for neoadjuvant or adjuvant treatment with HER2-blocking agents, following national guidelines for chemotherapy and antibody therapies. Participants will have baseline heart function tests (ECHO/MUGA) and NT-proBNP blood tests before starting trastuzumab treatment. NT-proBNP levels will then be measured again at 6 months and 12 months during treatment. If NT-proBNP levels rise at these times, patients will be referred for additional ECHO/MUGA scans. This approach is being studied as a possible replacement for routine ECHO/MUGA scans to reduce the need for more labor-intensive procedures. During the trial, participants will undergo heart function monitoring through blood tests and imaging scans at specified intervals. Researchers will measure the sensitivity and specificity of NT-proBNP in detecting cardiac dysfunction caused by trastuzumab from the start of treatment up to 24 months later. The study also tracks the prevalence of cardiotoxicity and changes in NT-proBNP related to anthracycline chemotherapy. Participants will be monitored closely with tests and follow-up visits to evaluate heart health and treatment effects over time.
CONDITIONS
Brief 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 according to local guidelines
- No distant metastasis (CT/MRI only if clinically indicated)
- Negative pregnancy test within 14 days before starting treatment
- Willingness to use effective contraception if able to become pregnant
- No other malignancy 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 and high risk of treatment termination
- Any medical condition (psychiatric, infectious, neurological, or abnormal lab 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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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months of HER2 blocking treatment
Participants receive neoadjuvant or adjuvant chemotherapy plus HER2 blocking agents as per national guidelines, with cardiac function monitored through blood tests measuring plasma NT-proBNP.
Visits at baseline, 6 months, and 12 months for blood tests to monitor heart function
Duration - Up to 24 months after baseline investigation
Participants are observed for trastuzumab-induced cardiotoxicity and changes in NT-proBNP levels following treatment completion.
Follow-up visits at 24 months after baseline
Trial Site Locations
Total: 1 location
1
Jubileumskliniken, Sahlgrenska University Hospital
Gothenburg, Sweden, 432 45
Actively Recruiting
Research Team
D
Daniel Giglio, Assoc Prof
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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