Breast CancerNCT00806507
Early Detection and Prediction of Chemotherapy Induced Cardiac Toxicity in Breast Cancer Patients
An observational study of Breast Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
The goal of this clinical research study is to learn whether different ways of viewing echocardiogram pictures along with blood tests can help to see heart-related side effects of chemotherapy and trastuzumab earlier than the usual tests. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Echocardiograms and Blood Test
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2008to Aug 2011
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients treated with chemotherapy and Herceptin (trastuzumab)
Who may be able to join
- Age 18 years or older
- HER-2 positive breast cancer
- Scheduled to receive Herceptin infusion therapy after exposure to anthracycline-based chemotherapy in one of the following manners: Adjuvant or neoadjuvant treatment with anthracycline-based chemotherapy preceded or followed by Herceptin infusion therapy, Herceptin monotherapy in patients with metastatic disease previously treated with anthracycline-based chemotherapy, Herceptin in combination with non-anthracycline chemotherapy in patients with metastatic disease previously treated with anthracycline-based chemotherapy
- Normal baseline left ventricular ejection fraction.
Who cannot join
- Pre-existing cardiomyopathy (Left Ventricular Ejection Fraction (LVEF) < 50%)
- Other contraindication to Herceptin therapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Partners Healthcare Systems
Boston, Massachusetts, 02199
UT MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this clinical research study is to learn whether different ways of viewing echocardiogram pictures along with blood tests can help to see heart-related side effects of chemotherapy and trastuzumab earlier than the usual tests.
Read the detailed description
Echocardiogram:
Because of the heart-related side effects of chemotherapy and trastuzumab, your regular doctor will monitor your heart's function as part of your routine care. You will have echocardiograms performed before you begin treatment, and then every 3 months. An echocardiogram uses sound waves to check your heart's health.
If you decide to take part in this study, researchers will take several additional pictures of your heart during each of your regularly scheduled echocardiograms. The additional pictures will make the procedure take about 5-10 minutes longer than the regular echocardiogram. These pictures will be viewed in a different way than the standard echocardiogram pictures. Researchers hope viewing the pictures this way can help researchers to find heart problems earlier than the usual tests.
Blood Tests:
Blood (about 4 teaspoon each time) will be drawn during the routine blood draw that occurs closest to the regularly scheduled echocardiograms.
The heart produces hormones called BNP and NT-proBNP. These hormones can be measured in the blood. BNP and NT-proBNP levels can be higher when the heart is not working as well. Researchers will measure these hormones at the time of each echocardiogram. Researchers hope to learn whether measuring these hormones can help identify the heart-related side effects of chemotherapy and trastuzumab earlier than the usual tests.
Researchers will also measure metabolic proteins (such as sugars and acids) in the blood. Researchers hope to learn whether measuring these metabolic proteins can help identify the heart-related side effects of chemotherapy and trastuzumab earlier than the usual tests.
Because protein, sugar or acid levels may be temporarily changed after you eat, you will be asked not to eat overnight before having your blood drawn.
Study Visits:
You will have 6 study visits around the time that you have an echocardiogram. These visits will occur before you take Herceptin, when you begin Herceptin, and 3, 6, 9, and 12 months later. These study visits will be scheduled on days when you are already making a visit to your regular doctor. You will not have to make any special visits to the hospital for this research study.
During each study visit, you will be asked about any symptoms you may be experiencing, and any medications you may be taking. Your blood pressure and heart rate will be measured.
You will also take a quality of life questionnaire at each study visit. This questionnaire asks you how the cancer may have interfered with your daily life. It should take about 15 minutes to complete.
Length of Study:
You will be considered off-study once you complete the 6 study visits.
This is an investigational study. Up to 100 patients will take part in this multicenter study. Up to 20 patients will be enrolled at M. D. Anderson.
- Conditions
- Breast Cancer
- Being tested
- Echocardiograms, Blood Test
- Keywords
- Tissue Doppler Imaging, B-type natriuretic peptide, Advia Centaur immunoassay system, GE Vivid ultrasound machine, Roche 2010 system, Echocardiography, Herceptin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiogramsProcedure or surgery
Additional views performed in 5-10 minutes of regularly scheduled echocardiograms.
Blood TestProcedure or surgery
Measuring of hormones and metabolic proteins (such as sugars and acids).
| Study group | Role | What they receive |
|---|---|---|
| Echocardiogram + Blood Test | Additional Echocardiogram views performed in 5-10 minutes of regularly scheduled echocardiograms plus blood tests measuring of hormones and metabolic proteins (such as sugars and acids). Receives: Procedure: Echocardiograms; Procedure: Blood Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictors of cardio-toxicity in female patients with breast cancer exposed to trastuzumab +/- previous anthracycline agents
Identification of heart-related side effects of chemotherapy and trastuzumab using echocardiogram pictures plus blood tests.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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 only
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Jose Banchs, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806507
- Sponsor's protocol ID
- 2007-0339
- Status last verified
- Jul 2012
- First submitted
- 20 Nov 2008
- Last updated
- 23 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection and Prediction of Chemotherapy Induced Cardiac Toxicity in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00806507
- Acronym / sponsor ID
- 2007-0339
- Conditions
- Breast Cancer
- Keywords
- Tissue Doppler Imaging, B-type natriuretic peptide, Advia Centaur immunoassay system, GE Vivid ultrasound machine, Roche 2010 system, Echocardiography, Herceptin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- Nov 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 10 Dec 2008 (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.
The goal of this clinical research study is to learn whether different ways of viewing echocardiogram pictures along with blood tests can help to see heart-related side effects of chemotherapy and trastuzumab earlier than the usual tests.
Detailed description
Echocardiogram:
Because of the heart-related side effects of chemotherapy and trastuzumab, your regular doctor will monitor your heart's function as part of your routine care. You will have echocardiograms performed before you begin treatment, and then every 3 months. An echocardiogram uses sound waves to check your heart's health.
If you decide to take part in this study, researchers will take several additional pictures of your heart during each of your regularly scheduled echocardiograms. The additional pictures will make the procedure take about 5-10 minutes longer than the regular echocardiogram. These pictures will be viewed in a different way than the standard echocardiogram pictures. Researchers hope viewing the pictures this way can help researchers to find heart problems earlier than the usual tests.
Blood Tests:
Blood (about 4 teaspoon each time) will be drawn during the routine blood draw that occurs closest to the regularly scheduled echocardiograms.
The heart produces hormones called BNP and NT-proBNP. These hormones can be measured in the blood. BNP and NT-proBNP levels can be higher when the heart is not working as well. Researchers will measure these hormones at the time of each echocardiogram. Researchers hope to learn whether measuring these hormones can help identify the heart-related side effects of chemotherapy and trastuzumab earlier than the usual tests.
Researchers will also measure metabolic proteins (such as sugars and acids) in the blood. Researchers hope to learn whether measuring these metabolic proteins can help identify the heart-related side effects of chemotherapy and trastuzumab earlier than the usual tests.
Because protein, sugar or acid levels may be temporarily changed after you eat, you will be asked not to eat overnight before having your blood drawn.
Study Visits:
You will have 6 study visits around the time that you have an echocardiogram. These visits will occur before you take Herceptin, when you begin Herceptin, and 3, 6, 9, and 12 months later. These study visits will be scheduled on days when you are already making a visit to your regular doctor. You will not have to make any special visits to the hospital for this research study.
During each study visit, you will be asked about any symptoms you may be experiencing, and any medications you may be taking. Your blood pressure and heart rate will be measured.
You will also take a quality of life questionnaire at each study visit. This questionnaire asks you how the cancer may have interfered with your daily life. It should take about 15 minutes to complete.
Length of Study:
You will be considered off-study once you complete the 6 study visits.
This is an investigational study. Up to 100 patients will take part in this multicenter study. Up to 20 patients will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Echocardiogram + Blood Test | – | Procedure: Echocardiograms, Procedure: Blood TestAdditional Echocardiogram views performed in 5-10 minutes of regularly scheduled echocardiograms plus blood tests measuring of hormones and metabolic proteins (such as sugars and acids). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients treated with chemotherapy and Herceptin (trastuzumab)
Key inclusion criteria (4 listed)
- Age 18 years or older
- HER-2 positive breast cancer
- Scheduled to receive Herceptin infusion therapy after exposure to anthracycline-based chemotherapy in one of the following manners: Adjuvant or neoadjuvant treatment with anthracycline-based chemotherapy preceded or followed by Herceptin infusion therapy, Herceptin monotherapy in patients with metastatic disease previously treated with anthracycline-based chemotherapy, Herceptin in combination with non-anthracycline chemotherapy in patients with metastatic disease previously treated with anthracycline-based chemotherapy
- Normal baseline left ventricular ejection fraction.
Key exclusion criteria (2 listed)
- Pre-existing cardiomyopathy (Left Ventricular Ejection Fraction (LVEF) < 50%)
- Other contraindication to Herceptin therapy
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 |
|---|---|---|
| EchocardiogramsAdditional views performed in 5-10 minutes of regularly scheduled echocardiograms. | Procedure or surgery | Echocardiogram + Blood Test |
| Blood TestMeasuring of hormones and metabolic proteins (such as sugars and acids). | Procedure or surgery | Echocardiogram + Blood Test |
Primary outcome
Predictors of cardio-toxicity in female patients with breast cancer exposed to trastuzumab +/- previous anthracycline agents
Time frame: Baseline to 12 months
Identification of heart-related side effects of chemotherapy and trastuzumab using echocardiogram pictures plus blood tests.
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 23 Jul 2012.
- The University of Texas M.D.Anderson 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.
Jose Banchs, MD principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by M.D. Anderson Cancer Center at 2 sites 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 4 inclusion and 2 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 23 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Predictors of cardio-toxicity in female patients with breast cancer exposed to trastuzumab +/- previous anthracycline agents (time frame: Baseline to 12 months). 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 23 Jul 2012.