CardiotoxicityNCT06340516
NT-proBNP to Assess Trastuzumab-induced Cardiotoxicity
A study testing Plasma NT-proBNP in people with Cardiotoxicity and Breast Cancer, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiotoxicity, Breast Cancer, Treatment Side Effects
- What is being tested?
- Plasma NT-proBNP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteSweden
- Study dates
- 14 Mar 2024to 14 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Jubileumskliniken, Sahlgrenska University Hospital
Gothenburg, 432 45
Daniel Giglio, Assoc Prof, +46(0)31-342 16 06, daniel.giglio@pharm.gu.se
About this study
Official title: 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
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.
Read the detailed description
Sponsor: Swedish Association of Breast Oncologists (SABO), Clinical Trial Unit, Department of Oncology, Sahlgrenska University Hospital, Gothenburg, Sweden.
Design:This is an national multicentre single arm phase II trial for patients with primary HER2 positive breast cancer planned for neoadjuvant/adjuvant treatment with HER2 blocking agents.
Purpose: The purpose of this study is to assess the sensitivity and specificity of NT-proBNP for detection of cardiac failure in patients with primary breast cancer that receive neoadjuvant/adjuvant treatment with HER2 blocking compounds.
Background: Patients with HER2 positive breast cancer > 20 mm and/or with lymph node metastasis receive, according to the national guidelines 4 courses of double antibody blockade with trastuzumab and pertuzumab plus a taxane for 12 weeks followed by EC (epirubicin/cyclophosphamide) every 3rd week times 3 in the neoadjuvant setting followed by continued HER2 blockade with trastuzumab or TDM-1 for a total of 17 courses. Patients with tumours < 20 mm and node-negative disease start with surgery followed by adjuvant treatment with EC x 4 followed by trastuzumab and a taxane for 12 weeks, thereafter trastuzumab x 13 is given as a single agent. For patients with tumours < 10 mm and node negative it is considered sufficient to give only a taxane plus trastuzumab for 12 weeks followed by trastuzumab times 13. The latter less toxic regimen has also been used in elderly fragile patients.
The risk of cardiac dysfunction as determined by a reduction in the Left Ventricular Ejection Fraction (LVEF) below 50% has been estimated to approximately 3-4% in the large registration trials.
Cardiac function is followed by repeated echocardiography (ECHO)/ Multigated Acquisition Scan (MUGA) that are performed before start of HER2 blocking treatment, after 6 and 12 months (when the treatment is completed.
Because cardiac toxicity is very low, a labour-intensive method needs to be carried out unnecessarily on a large number of patients. We have shown in a single centre pilot study of 136 patients that NT-proBNP has a high sensitivity and specificity compared with ECHO to correctly diagnose patients with cardiac toxicity during adjuvant/neoadjuvant HER2 treatment.
- Conditions
- Cardiotoxicity, Breast Cancer, Treatment Side Effects
- Being tested
- Plasma NT-proBNP
- Medical subject headings
- Cardiotoxicity, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma NT-proBNPDiagnostic test
Replacement of measurement of plasma NT-proBNP instead of ECHO/MUGA at 6 months and 12 months of trastuzumab treatment to assess cardiotoxicity
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Plasma NT-proBNP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: From inclusion to 24 months after baseline investigation
Secondary outcomes (2)
Prevalence of trastuzumab-induced cardiotoxicity
To determine the proportion of patients that develop cardiac toxicity during treatment with HER2 blocking agents for primary breast cancer
Measured: From inclusion to 24 months after baseline investigation
Anthracycline-induced change in NT-proBNP
To investigate the potential change of NT-proBNP during anthracycline-based chemotherapy in patients that receive EC followed by anti-HER2 blockade plus a taxane and whether it is correlated with the development of cardiac toxicity throughout anti-HER2 blockade.
[time frame from inclusion to 10 weeks after base-line investigation]
Measured: From inclusion to 10 weeks after baseline investigation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start14 Mar 2024
- Primary completion14 Mar 2029 (estimated)
- Study completion14 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiotoxicityStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Daniel Giglio, Assoc Prof, Principal investigator, Sahlgrenska University Hospital/University of GothenburgBarbro Linderholm, Assoc Prof, Principal investigator, Sahlgrenska University Hospital/University of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340516
- Sponsor's protocol ID
- HER2BNP
- Status last verified
- Mar 2024
- First submitted
- 25 Mar 2024
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06340516
- Acronym / sponsor ID
- HER2BNP
- Conditions
- Cardiotoxicity, Breast Cancer, Treatment Side Effects
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 14 Mar 2029 (estimated)
- Study completion
- 14 Mar 2029 (estimated)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Sponsor: Swedish Association of Breast Oncologists (SABO), Clinical Trial Unit, Department of Oncology, Sahlgrenska University Hospital, Gothenburg, Sweden.
Design:This is an national multicentre single arm phase II trial for patients with primary HER2 positive breast cancer planned for neoadjuvant/adjuvant treatment with HER2 blocking agents.
Purpose: The purpose of this study is to assess the sensitivity and specificity of NT-proBNP for detection of cardiac failure in patients with primary breast cancer that receive neoadjuvant/adjuvant treatment with HER2 blocking compounds.
Background: Patients with HER2 positive breast cancer > 20 mm and/or with lymph node metastasis receive, according to the national guidelines 4 courses of double antibody blockade with trastuzumab and pertuzumab plus a taxane for 12 weeks followed by EC (epirubicin/cyclophosphamide) every 3rd week times 3 in the neoadjuvant setting followed by continued HER2 blockade with trastuzumab or TDM-1 for a total of 17 courses. Patients with tumours < 20 mm and node-negative disease start with surgery followed by adjuvant treatment with EC x 4 followed by trastuzumab and a taxane for 12 weeks, thereafter trastuzumab x 13 is given as a single agent. For patients with tumours < 10 mm and node negative it is considered sufficient to give only a taxane plus trastuzumab for 12 weeks followed by trastuzumab times 13. The latter less toxic regimen has also been used in elderly fragile patients.
The risk of cardiac dysfunction as determined by a reduction in the Left Ventricular Ejection Fraction (LVEF) below 50% has been estimated to approximately 3-4% in the large registration trials.
Cardiac function is followed by repeated echocardiography (ECHO)/ Multigated Acquisition Scan (MUGA) that are performed before start of HER2 blocking treatment, after 6 and 12 months (when the treatment is completed.
Because cardiac toxicity is very low, a labour-intensive method needs to be carried out unnecessarily on a large number of patients. We have shown in a single centre pilot study of 136 patients that NT-proBNP has a high sensitivity and specificity compared with ECHO to correctly diagnose patients with cardiac toxicity during adjuvant/neoadjuvant HER2 treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| NT-proBNP instead of ECHO/MUGA at 6 months and 12 months | Experimental | Diagnostic Test: Plasma NT-proBNPReplacement with measurement of plasma levels of NT-proBNP at 6 months and 12 months instead of ECHO/MUGA for monitoring of trastuzumab-induced cardiotoxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (5 listed)
- 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).
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma NT-proBNPReplacement of measurement of plasma NT-proBNP instead of ECHO/MUGA at 6 months and 12 months of trastuzumab treatment to assess cardiotoxicity | Diagnostic test | NT-proBNP instead of ECHO/MUGA at 6 months and 12 months |
Primary outcome
Sensitivity and specificity of NT-proBNP to detect trastuzumab-induced cardiotoxicity
Time frame: From inclusion to 24 months after baseline investigation
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]
2 secondary outcomes
Prevalence of trastuzumab-induced cardiotoxicity
Time frame: From inclusion to 24 months after baseline investigation
Anthracycline-induced change in NT-proBNP
Time frame: From inclusion to 10 weeks after baseline investigation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Giglio, Assoc Prof principal investigator
Sahlgrenska University Hospital/University of Gothenburg
Barbro Linderholm, Assoc Prof principal investigator
Sahlgrenska University Hospital/University of Gothenburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasma NT-proBNP in people with Cardiotoxicity and Breast Cancer, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Giglio, Assoc Prof (+46(0)31-342 16 06, daniel.giglio@pharm.gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of NT-proBNP to detect trastuzumab-induced cardiotoxicity (time frame: From inclusion to 24 months after baseline investigation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024.