CardiotoxicityNCT03155802
Novel Biomarkers and Echocardiography for Subclinical Cardiac Toxicity in Breast Cancer Patients Receiving Anthracyclines
An observational study of Cardiotoxicity and Heart Failure, run by Stony Brook University at 1 site in United States.
Trial summary
This is a pilot prospective cohort study, in adult female subjects 18-85 years old with a diagnosis of invasive breast cancer who are planned for anthracycline-inclusive chemotherapy and followed up for a time period of 6 months post completion of anthracycline chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Cardiotoxicity, Heart Failure, Breast Cancer
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2017to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: females between the ages of 18-85 with diagnosis of invasive breast cancer, planned for anthracycline inclusive chemotherapy (+/- taxanes, +/- trastuzumab).
Who may be able to join
- Female subjects aged 18-85 years old
- Biopsy-proven diagnosis of invasive breast cancer carcinoma
- Plan for anthracycline inclusive chemotherapy (+/- taxanes, +/- trastuzumab)
Who cannot join
- History of major heart disease at the time of breast cancer diagnosis (myocardial infarction or known left ventricular dysfunction (LVD) at baseline (defined as ejection fraction <40%)
- History of known obstructive coronary artery disease (CAD), or coronary revascularization within the past 1 year
- History of clinical heart failure or previous heart failure hospitalization
- Patients with elevations in NT-pro BNP (above 3x ULN), or ST2 (above 2x ULN), galectin-3 (above 2x ULN), or hs troponin (above 2x ULN) during baseline screening
- Patients with metastatic disease or recurrent breast cancer at diagnosis
- History of other chemotherapy treated malignancy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Stony Brook Medicine
Stony Brook, New York, 11738
Michelle Bloom, MD, 631-444-2031, michelle.bloom@stonybrookmedicine.edu
About this study
Official title: Use of Novel Biomarkers and Echocardiography to Assess Subclinical Cardiac Toxicity in Breast Cancer Patients Receiving Anthracyclines
This is a pilot prospective cohort study, in adult female subjects 18-85 years old with a diagnosis of invasive breast cancer who are planned for anthracycline-inclusive chemotherapy and followed up for a time period of 6 months post completion of anthracycline chemotherapy. They will participate in blood and imaging tests with a goal of determining the best method for predicting the occurrence of cardiotoxicity in this subpopulation.
Read the detailed description
Anthracyclines and other chemotherapy agents are associated with cardiotoxicity. The risk of cardiac related toxicity is increased in patients with advanced age, with multiple comorbid conditions, and those needing prolonged or intensive treatment. These patients require a tailored approach to surveillance, early diagnosis and treatment of cardiac issues related to cancer therapy, with timely decision making with respect to alterations in therapy. A serum biomarker approach alone or in combination with imaging indices holds promise for early identification, risk stratification and monitoring of chemotherapy related cardiotoxicity.
Thirty-five consecutive adult females between the ages of 18-85 with diagnosis of invasive breast cancer, planned for anthracycline inclusive chemotherapy (+/- taxanes, +/- trastuzumab) will be enrolled.
A detailed medical history (interim where appropriate), physical exam, collection of blood samples for the measurement of Heart Failure (HF) biomarkers (and standard chemistry and hematology parameters), electrocardiogram and a 2D/3D echo cardiogram including the measurement of global longitudinal strain will be performed at baseline, mid chemotherapy, at the end of chemotherapy and 6 months post the completion of chemotherapy. (echocardiogram will not be done during chemotherapy).
The hypothesis being tested in this prospective trial is whether early changes in the levels of serum biomarkers of stress (N terminal pro B-type natriuretic peptide (NT-proBNP)), inflammation (ST2), necrosis (hs troponin), and fibrosis (galectin-3) will correlate with changes in sub-clinical left ventricular dysfunction as assessed by 3-dimensional (3D) echocardiogram with speckle tracking/strain in breast cancer patients receiving anthracycline based chemotherapy.
- Conditions
- Cardiotoxicity, Heart Failure, Breast Cancer, Anthracycline Induced Cardiomyopathy, Biomarkers, Echocardiography
- Medical subject headings
- Cardiotoxicity, Heart Failure, Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of Heart Failure Biomarkers with Global Longitudinal strain rate
N Terminal-proBNP, hs troponin, ST2, galectin-3 with global longitudinal strain rate
Measured: up to 35 weeks
Secondary outcomes (8)
Prediction of initiation/change in cardiovascular medications based on serum biomarkers
NT-proBNP
Measured: up to 35 weeks
Prediction of initiation/change in cardiovascular medications based on serum biomarkers
ST2
Measured: up to 35 weeks
Prediction of initiation/change in cardiovascular medications based on serum biomarkers
hs-troponin
Measured: up to 35 weeks
Prediction of initiation/change in cardiovascular medications based on serum biomarkers
galectin-3
Measured: up to 35 weeks
Prediction of cardiotoxicity based on serum biomarkers
galectin-3
Measured: up to 35 weeks
Prediction of cardiotoxicity based on serum biomarkers
NT-proBNP
Measured: up to 35 weeks
Prediction of cardiotoxicity based on serum biomarkers
hs-troponin
Measured: up to 35 weeks
Prediction of cardiotoxicity based on serum biomarkers
ST2
Measured: up to 35 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start18 Apr 2017
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155802
- Sponsor's protocol ID
- 922042
- Status last verified
- Oct 2019
- First submitted
- 17 Apr 2017
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Novel Biomarkers and Echocardiography to Assess Subclinical Cardiac Toxicity in Breast Cancer Patients Receiving Anthracyclines
- ClinicalTrials.gov ID
- NCT03155802
- Acronym / sponsor ID
- 922042
- Conditions
- Cardiotoxicity, Heart Failure, Breast Cancer, Anthracycline Induced Cardiomyopathy, Biomarkers, Echocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 16 May 2017 (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.
This is a pilot prospective cohort study, in adult female subjects 18-85 years old with a diagnosis of invasive breast cancer who are planned for anthracycline-inclusive chemotherapy and followed up for a time period of 6 months post completion of anthracycline chemotherapy. They will participate in blood and imaging tests with a goal of determining the best method for predicting the occurrence of cardiotoxicity in this subpopulation.
Detailed description
Anthracyclines and other chemotherapy agents are associated with cardiotoxicity. The risk of cardiac related toxicity is increased in patients with advanced age, with multiple comorbid conditions, and those needing prolonged or intensive treatment. These patients require a tailored approach to surveillance, early diagnosis and treatment of cardiac issues related to cancer therapy, with timely decision making with respect to alterations in therapy. A serum biomarker approach alone or in combination with imaging indices holds promise for early identification, risk stratification and monitoring of chemotherapy related cardiotoxicity.
Thirty-five consecutive adult females between the ages of 18-85 with diagnosis of invasive breast cancer, planned for anthracycline inclusive chemotherapy (+/- taxanes, +/- trastuzumab) will be enrolled.
A detailed medical history (interim where appropriate), physical exam, collection of blood samples for the measurement of Heart Failure (HF) biomarkers (and standard chemistry and hematology parameters), electrocardiogram and a 2D/3D echo cardiogram including the measurement of global longitudinal strain will be performed at baseline, mid chemotherapy, at the end of chemotherapy and 6 months post the completion of chemotherapy. (echocardiogram will not be done during chemotherapy).
The hypothesis being tested in this prospective trial is whether early changes in the levels of serum biomarkers of stress (N terminal pro B-type natriuretic peptide (NT-proBNP)), inflammation (ST2), necrosis (hs troponin), and fibrosis (galectin-3) will correlate with changes in sub-clinical left ventricular dysfunction as assessed by 3-dimensional (3D) echocardiogram with speckle tracking/strain in breast cancer patients receiving anthracycline based chemotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- females between the ages of 18-85 with diagnosis of invasive breast cancer, planned for anthracycline inclusive chemotherapy (+/- taxanes, +/- trastuzumab).
Key inclusion criteria (3 listed)
- Female subjects aged 18-85 years old
- Biopsy-proven diagnosis of invasive breast cancer carcinoma
- Plan for anthracycline inclusive chemotherapy (+/- taxanes, +/- trastuzumab)
Key exclusion criteria (6 listed)
- History of major heart disease at the time of breast cancer diagnosis (myocardial infarction or known left ventricular dysfunction (LVD) at baseline (defined as ejection fraction <40%)
- History of known obstructive coronary artery disease (CAD), or coronary revascularization within the past 1 year
- History of clinical heart failure or previous heart failure hospitalization
- Patients with elevations in NT-pro BNP (above 3x ULN), or ST2 (above 2x ULN), galectin-3 (above 2x ULN), or hs troponin (above 2x ULN) during baseline screening
- Patients with metastatic disease or recurrent breast cancer at diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association of Heart Failure Biomarkers with Global Longitudinal strain rate
Time frame: up to 35 weeks
N Terminal-proBNP, hs troponin, ST2, galectin-3 with global longitudinal strain rate
8 secondary outcomes
Prediction of initiation/change in cardiovascular medications based on serum biomarkers
Time frame: up to 35 weeks
Prediction of initiation/change in cardiovascular medications based on serum biomarkers
Time frame: up to 35 weeks
Prediction of initiation/change in cardiovascular medications based on serum biomarkers
Time frame: up to 35 weeks
Prediction of initiation/change in cardiovascular medications based on serum biomarkers
Time frame: up to 35 weeks
Prediction of cardiotoxicity based on serum biomarkers
Time frame: up to 35 weeks
Prediction of cardiotoxicity based on serum biomarkers
Time frame: up to 35 weeks
Prediction of cardiotoxicity based on serum biomarkers
Time frame: up to 35 weeks
Prediction of cardiotoxicity based on serum biomarkers
Time frame: up to 35 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Individual participant dataSharing planned: No
Related trials for Cardiotoxicity
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
RecruitingObservational study
3D Versus 2D Strain Echocardiography for Early Detection of Cardiotoxicity During Cancer Therapy
Cancer Related Cardiovascular Toxicity, Anthracycline Related Cardiotoxicity in Breast Cancer
RecruitingPhase 3
Assessment of The Potential Therapeutic Effects of Trimetazidine on Aluminium Phosphide-Induced Cardiotoxicity as an Adjuvant Therapy: A Pilot Study
Aluminum Phosphide Poisoning
Not yet recruitingPhase 2
The Impact of Using Nicorandil for the Prevention of Doxorubicin-Induced Cardiotoxicity
Doxorubicin Induced Cardiotoxicity, Doxorubicin Induced Cardiomyopathy
Not yet recruitingObservational study
PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study
Heart Failure, Coronary Artery Disease
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiotoxicity and Heart Failure, run by Stony Brook University at 1 site in United States.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 1 Nov 2019. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michelle Bloom, MD (6314442031, michelle.bloom@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of Heart Failure Biomarkers with Global Longitudinal strain rate (time frame: up to 35 weeks). 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 Nov 2019.