Trastuzumab CardiotoxicityNCT02615054
Assessment for Long-Term Cardiovascular Impairment Associated With Trastuzumab Cardiotoxicity in HER2-Positive Breast Cancer Survivors
An observational study of Trastuzumab Cardiotoxicity and HER2-Positive Breast Cancer Survivors, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
This is for participants with a history of HER2-positive breast cancer and were treated with chemotherapy that increases the risk of abnormal heart function. Strain (a marker of heart function) is a new method of monitoring heart function in cancer patients and is measured with an ultrasound. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Trastuzumab Cardiotoxicity, HER2-Positive Breast Cancer Survivors
- What is being tested?
- 2D Echocardiogram and Cardiopulmonary exercise testing and post-CPET cardiac function
- Type of treatment
- Medical device
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2015to 5 Mar 2024
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Potentially eligible subjects who meet the eligibility criteria and who were treated at MSK between 2005 and 2010 will be identified through query of MSK institutional databases. Healthy control subjects will be largely recruited from (though not restricted to) MSK employees.
Who may be able to join
- All patients:
- Aged ≥ 18 years
- Female
- MSK histologically confirmed primary invasive breast carcinoma
- Pathologically confirmed HER2-positive breast cancer
- Treated with adjuvant trastuzumab (either alone or in combination with other anti-HER2 agents)
Show all 24Show fewer
- ≥ 2 years since completion of targeted chemotherapy without evidence of disease
- Willing and able to comply with the requirements of the protocol
- Patients in the cardiotoxicity (TOX) group must meet the following criteria:
- Development of treatment associated cardiotoxicity during trastuzumab therapy, defined as an absolute decrease from baseline in LVEF by ≥ 10%, to an LVEF of below 55%.
- No clinical signs or symptoms of heart failure (NYHA class III or IV) at the time of cardiotoxicity.
- Note: NYHA Class III symptoms include marked limitation of physical activity. Less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain. NYHA Class IV symptoms include inability to carry on any physical activity without discomfort. Symptoms of heart failure or anginal syndrome may be present at rest, and if any physical activity is undertaken, discomfort is increased.
- Patients in the no cardiotoxicity (NO-TOX) group must meet the following criteria:
- Maximum absolute decrease in LVEF ≤ 5% from baseline during trastuzumab therapy.
- Echocardiogram with LVEF assessment performed at baseline (prior to initiation of trastuzumab therapy) and at least two timepoints during trastuzumab therapy.
- LVEF ≥ 55% on each echocardiogram assessment during trastuzumab therapy.
- No clinical signs or symptoms of heart failure (NYHA class III or IV) during trastuzumab treatment.
- Note: NYHA Class III symptoms include marked limitation of physical activity. Less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain. NYHA Class IV symptoms include inability to carry on any physical activity without discomfort. Symptoms of heart failure or anginal syndrome may be present at rest, and if any physical activity is undertaken, discomfort is increased.
- Participants in the healthy control group must meet the following criteria:
- Aged ≥ 40 years
- Female
- No history of cancer with the exception of localized basal and/or squamous cell carcinoma of the skin
- No prior history of known cardiac disease (e.g. ischemic heart disease, heart failure, cardiomyopathy, or valvular heart disease [moderate to severe], or significant arrhythmias).
- Willing and able to comply with the requirements of the protocol
Who cannot join
- Inability to provide informed consent
- Presence of metastatic disease
- Treatment with additional cardiotoxic therapy for a secondary malignant neoplasm, or treatment with additional cardiotoxic therapy for breast cancer recurrence since primary breast cancer diagnosis [Note: Patients who are diagnosed with a second primary malignancy are not excluded from participation in the study, unless they meet this exclusion criterion.]
- Subjects must not have any of the following absolute contraindications to cardiopulmonary exercise testing : (a) acute myocardial infarction (within 3-5 days of any planned study procedures), (b) unstable angina, (c) uncontrolled arrhythmias causing symptoms or hemodynamic compromise, (d) symptomatic severe aortic stenosis, (e) recurrent syncope, (f) active endocarditis, (g) acute myocarditis or pericarditis, (h) uncontrolled heart failure, (i) acute pulmonary embolus or pulmonary infarction, (within 3 months of any planned study procedures), (j) thrombosis of lower extremities, (k) suspected dissecting aneurysm, (l) uncontrolled asthma, (m) pulmonary edema (within 3 months of planned study procedures), (n) room air desaturation at rest ≤85%, (o) respiratory failure, (p) acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis), or (q) mental impairment leading to inability to cooperate.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
This is for participants with a history of HER2-positive breast cancer and were treated with chemotherapy that increases the risk of abnormal heart function. Strain (a marker of heart function) is a new method of monitoring heart function in cancer patients and is measured with an ultrasound. Exercise testing is another method that can be used to monitor for abnormal heart function in cancer patients. The purpose of this study is to see if strain and exercise testing can be used to detect for late signs of heart damage from chemotherapy.
- Being tested
- 2D Echocardiogram, Cardiopulmonary exercise testing and post-CPET cardiac function
- Keywords
- Cardiovascular Impairment, 15-258
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2D EchocardiogramDevice
All patients will undergo a two-dimensional echocardiogram with speckle tracking strain analysis within the MSK echocardiography laboratory.
Cardiopulmonary exercise testing and post-CPET cardiac functionDevice
To determine VO2peak, an electronic motorized treadmill test with 12-lead ECG monitoring (Mac ® 5000, GE Healthcare) will be performed by certified exercise physiologists.
| Study group | Role | What they receive |
|---|---|---|
| treated with trastuzmab no cardiac effects | Not described Receives: Device: 2D Echocardiogram; Device: Cardiopulmonary exercise testing and post-CPET cardiac function | |
| treated with trastuzmab with cardiac effects | Not described Receives: Device: 2D Echocardiogram; Device: Cardiopulmonary exercise testing and post-CPET cardiac function | |
| healthy volunteers no cancer treatment | Not described Receives: Device: 2D Echocardiogram; Device: Cardiopulmonary exercise testing and post-CPET cardiac function |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac function
Exercise capacity will be assessed by CPET, and echocardiographic images will be obtained immediately after CPET to evaluate contractile reserve.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study start18 Nov 2015
- Primary completion5 Mar 2024
- Study completion5 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trastuzumab CardiotoxicityStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Yu, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615054
- Sponsor's protocol ID
- 15-258
- Status last verified
- Apr 2024
- First submitted
- 19 Nov 2015
- Last updated
- 11 Apr 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment for Long-Term Cardiovascular Impairment Associated With Trastuzumab Cardiotoxicity in HER2-Positive Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT02615054
- Acronym / sponsor ID
- 15-258
- Keywords
- Cardiovascular Impairment, 15-258
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 18 Nov 2015 (actual)
- Primary completion
- 5 Mar 2024 (actual)
- Study completion
- 5 Mar 2024 (actual)
- First posted
- 25 Nov 2015 (estimated)
- 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 for participants with a history of HER2-positive breast cancer and were treated with chemotherapy that increases the risk of abnormal heart function. Strain (a marker of heart function) is a new method of monitoring heart function in cancer patients and is measured with an ultrasound. Exercise testing is another method that can be used to monitor for abnormal heart function in cancer patients. The purpose of this study is to see if strain and exercise testing can be used to detect for late signs of heart damage from chemotherapy.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| treated with trastuzmab no cardiac effects | – | Device: 2D Echocardiogram, Device: Cardiopulmonary exercise testing and post-CPET cardiac function |
| treated with trastuzmab with cardiac effects | – | Device: 2D Echocardiogram, Device: Cardiopulmonary exercise testing and post-CPET cardiac function |
| healthy volunteers no cancer treatment | – | Device: 2D Echocardiogram, Device: Cardiopulmonary exercise testing and post-CPET cardiac function |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Potentially eligible subjects who meet the eligibility criteria and who were treated at MSK between 2005 and 2010 will be identified through query of MSK institutional databases. Healthy control subjects will be largely recruited from (though not restricted to) MSK employees.
Key inclusion criteria (24 listed)
- Aged ≥ 18 years
- Female
- MSK histologically confirmed primary invasive breast carcinoma
- Pathologically confirmed HER2-positive breast cancer
- Treated with adjuvant trastuzumab (either alone or in combination with other anti-HER2 agents)
Key exclusion criteria (4 listed)
- Inability to provide informed consent
- Presence of metastatic disease
- Treatment with additional cardiotoxic therapy for a secondary malignant neoplasm, or treatment with additional cardiotoxic therapy for breast cancer recurrence since primary breast cancer diagnosis [Note: Patients who are diagnosed with a second primary malignancy are not excluded from participation in the study, unless they meet this exclusion criterion.]
- Subjects must not have any of the following absolute contraindications to cardiopulmonary exercise testing : (a) acute myocardial infarction (within 3-5 days of any planned study procedures), (b) unstable angina, (c) uncontrolled arrhythmias causing symptoms or hemodynamic compromise, (d) symptomatic severe aortic stenosis, (e) recurrent syncope, (f) active endocarditis, (g) acute myocarditis or pericarditis, (h) uncontrolled heart failure, (i) acute pulmonary embolus or pulmonary infarction, (within 3 months of any planned study procedures), (j) thrombosis of lower extremities, (k) suspected dissecting aneurysm, (l) uncontrolled asthma, (m) pulmonary edema (within 3 months of planned study procedures), (n) room air desaturation at rest ≤85%, (o) respiratory failure, (p) acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis), or (q) mental impairment leading to inability to cooperate.
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 |
|---|---|---|
| 2D EchocardiogramAll patients will undergo a two-dimensional echocardiogram with speckle tracking strain analysis within the MSK echocardiography laboratory. | Device | healthy volunteers no cancer treatment, treated with trastuzmab no cardiac effects, treated with trastuzmab with cardiac effects |
| Cardiopulmonary exercise testing and post-CPET cardiac functionTo determine VO2peak, an electronic motorized treadmill test with 12-lead ECG monitoring (Mac ® 5000, GE Healthcare) will be performed by certified exercise physiologists. | Device | healthy volunteers no cancer treatment, treated with trastuzmab no cardiac effects, treated with trastuzmab with cardiac effects |
Primary outcome
cardiac function
Time frame: 2 years
Exercise capacity will be assessed by CPET, and echocardiographic images will be obtained immediately after CPET to evaluate contractile reserve.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Anthony Yu, MD principal investigator
Memorial Sloan Kettering Cancer Center
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 Trastuzumab Cardiotoxicity and HER2-Positive Breast Cancer Survivors, run by Memorial Sloan Kettering Cancer Center 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 24 inclusion and 4 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: finished, as of the sponsor's last update on 11 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiac function (time frame: 2 years). 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 11 Apr 2024.