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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histological confirmed HER2 positive primary BC planned for adjuvant/neoadjuvant treatment with chemotherapy plus HER2 blocking agents.

• Patients ≥18 years

• ECOG/WHO 0-1

• Adequate organ function for the planned treatment according to local guidelines.

• No distant metastasis (CT/MRI only if clinically indicated).

• Negative pregnancy test within 14 days prior to start of treatment.

• If of childbearing potential, willing to use an effective form of contraception.

• 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.

• Signed informed consent and willingness to follow the trial procedures.

Locations
Other Locations
Sweden
Jubileumskliniken, Sahlgrenska University Hospital
RECRUITING
Gothenburg
Contact Information
Primary
Daniel Giglio, Assoc Prof
daniel.giglio@pharm.gu.se
+46(0)31-342 16 06
Time Frame
Start Date: 2024-03-14
Estimated Completion Date: 2029-03-14
Participants
Target number of participants: 700
Treatments
Experimental: NT-proBNP instead of ECHO/MUGA at 6 months and 12 months
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
Related Therapeutic Areas
Sponsors
Leads: Vastra Gotaland Region

This content was sourced from clinicaltrials.gov