Monitoring heart health in breast cancer patients receiving trastuzumab
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
This study is testing if measuring a specific blood marker can help track heart health in breast cancer patients getting trastuzumab treatment, to see if it can replace traditional heart scans.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vastra Gotaland Region Government |
| Drugs / interventions | chemotherapy, Trastuzumab, pertuzumab, cyclophosphamide |
| Locations | 1 site (Gothenburg) |
| Trial ID | NCT06340516 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed HER2 positive primary breast cancer planned for neoadjuvant or adjuvant treatment.
Not a fit: Patients with a history of heart disease or other significant medical conditions that may complicate treatment are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a less invasive and more efficient method for monitoring heart health in breast cancer patients undergoing trastuzumab treatment.
How similar studies have performed: While this approach is novel in the context of trastuzumab treatment, previous studies have explored NT-proBNP as a cardiac biomarker in other settings, showing promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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). \-
Where this trial is running
Gothenburg
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.