RecruitingNot ApplicableNCT06340516

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


Sponsor

Vastra Gotaland Region

Enrollment

700 participants

Start Date

Mar 14, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether a blood marker called NT-proBNP (a sign of heart stress) can predict which breast cancer patients on trastuzumab (Herceptin) — a HER2-targeted drug — are at risk of heart damage, with the goal of personalizing heart monitoring during treatment. **You may be eligible if...** - You have HER2-positive breast cancer confirmed by biopsy - You are starting chemotherapy plus HER2-blocking therapy (such as trastuzumab) - Your cancer is being treated before or after surgery (not metastatic) - You are 18 or older with good overall health (ECOG 0–1) - You have adequate organ function - You are not pregnant (negative pregnancy test required) and use effective contraception if applicable **You may NOT be eligible if...** - You have a prior heart condition that would require special monitoring and may lead to stopping treatment early - You have another serious medical condition affecting the planned treatment - You are pregnant or breastfeeding - You have another active cancer requiring treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTPlasma 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


Locations(1)

Jubileumskliniken, Sahlgrenska University Hospital

Gothenburg, Sweden

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06340516


Related Trials