Monitoring heart health in breast cancer patients receiving trastuzumab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to monitor trastuzumab-induced cardiotoxicity in patients with HER2 positive breast cancer undergoing treatment. It involves measuring plasma NT-proBNP levels at baseline, 6 months, and 12 months during trastuzumab treatment, alongside echocardiography assessments. The goal is to evaluate the effectiveness of NT-proBNP as a biomarker for detecting cardiac failure and to determine if it can replace traditional echocardiography methods. This national multicenter trial will provide insights into cardiac health in breast cancer patients receiving HER2 blocking agents.

Why it matters

Who can join: the full rules

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).

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Where it's running

• Jubileumskliniken, Sahlgrenska University Hospital
  Gothenburg, Sweden Recruiting

Study contacts

• Principal investigator: Daniel Giglio, Assoc Prof — Sahlgrenska University Hospital/University of Gothenburg
• Study coordinator: Daniel Giglio, Assoc Prof
• Email: daniel.giglio@pharm.gu.se
• Phone: +46(0)31-342 16 06

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.