Clinical trial · Interventional
NT-proBNP to Assess Trastuzumab-induced Cardiotoxicity
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cardiotoxicity | — | UNRESOLVED | — |
| Treatment Side Effects | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Plasma NT-proBNP | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NT-proBNP instead of ECHO/MUGA at 6 months and 12 months
- description
- Replacement with measurement of plasma levels of NT-proBNP at 6 months and 12 months instead of ECHO/MUGA for monitoring of trastuzumab-induced cardiotoxicity
- interventionNames
- Diagnostic Test: Plasma NT-proBNP
Primary outcomes (1)
- measure
- Sensitivity and specificity of NT-proBNP to detect trastuzumab-induced cardiotoxicity
- timeFrame
- From inclusion to 24 months after baseline investigation
- description
- To determine the sensitivity and specificity of NT-proBNP for identification of patients that develop cardiac toxicity during treatment with HER2 blocking agents for primary breast cancer \[time frame from inclusion to 24 months after base-line investigation\]
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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). \-
References
Publications (0)
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