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Clinical Trials in Sweden / NCT06340516
Recruiting Not applicable

NT-proBNP to Assess Trastuzumab-induced Cardiotoxicity

NCT06340516 · tracked via the Priya Life Science Sweden tracker
Sponsor
Vastra Gotaland Region
Phase
Not applicable
Started
2024-03-14
Last updated
2024-04-01

Condition(s) studied

CardiotoxicityBreast CancerTreatment Side Effects

Investigational drug(s) / intervention(s)

Plasma NT-proBNP

Plasma NT-proBNP: Replacement of measurement of plasma NT-proBNP instead of ECHO/MUGA at 6 months and 12 months of trastuzumab treatment to assess cardiotoxicity

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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). \-

Primary outcome measure(s)

  • Sensitivity and specificity of NT-proBNP to detect trastuzumab-induced cardiotoxicity — From inclusion to 24 months after baseline investigation
    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 \[time frame from inclusion to 24 months after base-line investigation\]

Trial sites (1)

FacilityCityRegionStatus
Jubileumskliniken, Sahlgrenska University Hospital Gothenburg Sweden Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06340516 on ClinicalTrials.gov ↗ ← All trials in Sweden