NCT06340516 NT-proBNP to Assess Trastuzumab-induced Cardiotoxicity
| NCT ID | NCT06340516 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vastra Gotaland Region |
| Condition | Cardiotoxicity |
| Study Type | INTERVENTIONAL |
| Enrollment | 700 participants |
| Start Date | 2024-03-14 |
| Primary Completion | 2029-03-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 700 participants in total. It began in 2024-03-14 with a primary completion date of 2029-03-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. Histological confirmed HER2 positive primary BC planned for adjuvant/neoadjuvant treatment with chemotherapy plus HER2 blocking agents. 2. Patients ≥18 years 3. ECOG/WHO 0-1 4. Adequate organ function for the planned treatment according to local guidelines. 5. No distant metastasis (CT/MRI only if clinically indicated). 6. Negative pregnancy test within 14 days prior to start of treatment. 7. If of childbearing potential, willing to use an effective form of contraception. 8. 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. 9. Signed informed consent and willingness to follow the trial procedures. Exclusion Criteria: 1. Patients with previous heart disease recommended special follow-up during treatment with high risk of termination of treatment. 2. 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. 3. Pregnancy and breast feeding. 4. Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ). \-
Contact & Investigator
Daniel Giglio, Assoc Prof
PRINCIPAL INVESTIGATOR
Sahlgrenska University Hospital/University of Gothenburg
Frequently Asked Questions
Who can join the NCT06340516 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiotoxicity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06340516 currently recruiting?
Yes, NCT06340516 is actively recruiting participants. Contact the research team at daniel.giglio@pharm.gu.se for enrollment information.
Where is the NCT06340516 trial being conducted?
This trial is being conducted at Gothenburg, Sweden.
Who is sponsoring the NCT06340516 clinical trial?
NCT06340516 is sponsored by Vastra Gotaland Region. The principal investigator is Daniel Giglio, Assoc Prof at Sahlgrenska University Hospital/University of Gothenburg. The trial plans to enroll 700 participants.