NT-proBNP to Assess Trastuzumab-induced Cardiotoxicity

NCT06340516 | Recruiting DMC

• 1 other identifier: HER2BNP
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiotoxicity; Breast Cancer; Treatment Side Effects

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of NT-proBNP to detect trastuzumab-induced cardiotoxicity

  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 \[time frame from inclusion to 24 months after base-line investigation\]

  From inclusion to 24 months after baseline investigation

Secondary Outcomes (2)

• Prevalence of trastuzumab-induced cardiotoxicity

  From inclusion to 24 months after baseline investigation

• Anthracycline-induced change in NT-proBNP

  From inclusion to 10 weeks after baseline investigation

Study Arms (1)

NT-proBNP instead of ECHO/MUGA at 6 months and 12 months

EXPERIMENTAL

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

Diagnostic Test: Plasma NT-proBNP

Interventions

Plasma NT-proBNP DIAGNOSTIC_TEST

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

NT-proBNP instead of ECHO/MUGA at 6 months and 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with previous heart disease recommended special follow-up during treatment with high risk of termination of treatment.
• 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.
• Pregnancy and breast feeding.
• Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ).

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Jubileumskliniken, Sahlgrenska University Hospital

Gothenburg, 432 45, Sweden

RECRUITING

MeSH Terms

Conditions

Cardiotoxicity; Breast Neoplasms

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Daniel Giglio, Assoc Prof

  Sahlgrenska University Hospital/University of Gothenburg

  PRINCIPAL INVESTIGATOR

• Barbro Linderholm, Assoc Prof

  Sahlgrenska University Hospital/University of Gothenburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Giglio, Assoc Prof

CONTACT

+46(0)31-342 16 06; daniel.giglio@pharm.gu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This is a national multicentre phase II trial investigating the sensitivity and specificity of NT-proBNP for the diagnose of cardiac toxicity during primary anti-HER2 blockade. NT-proBNP is compared with the todays´ standard (ECHO/MUGA).

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: March 14, 2024
• Primary Completion (Estimated): March 14, 2029
• Study Completion (Estimated): March 14, 2029
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)