Her 2 Positive Breast CancerNCT02080390
Strain Imaging in Breast Cancer Patients Receiving Trastuzumab
An observational study of Her 2 Positive Breast Cancer, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate the effects of the chemotherapeutic drug, Trastuzumab (Herceptin) on the heart. Trastuzumab (Herceptin) is used to treat specific types of breast cancer and is known to cause weakening of the heart. Unfortunately, little is know as to why this this happens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Her 2 Positive Breast Cancer
- What is being tested?
- Transthoracic echocardiogram (ultrasound)
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 14 Feb 2019
- 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: Women or men recieveing Trastuzumab (Herceptin) for HER2 positive breast cancer.
Who may be able to join
- Age greater than 18 years
- Her 2 positive breast cancer.
- Patients who are currently receiving Trastuzumab (Herceptin).
- Patients who received Trastuzumab (Herceptin) after the formation of the UFHealth Medical Plaza pharmacy database was initiated.
Who cannot join
- Age less than 18 years
- Patients who have not received Trastuzumab (Herceptin).
- Patients who received Trastuzumab prior to the formation of the UFHealth Medical Plaza pharmacy database.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research study is to evaluate the effects of the chemotherapeutic drug, Trastuzumab (Herceptin) on the heart. Trastuzumab (Herceptin) is used to treat specific types of breast cancer and is known to cause weakening of the heart. Unfortunately, little is know as to why this this happens. The investigators want to identify any factors that may lead to the early detection, treatment and prevention of the cardiotoxicity (heart problem) associated with this drug.
Read the detailed description
As a subject participating in this study the following information will be collected: complete past medical history including age, height, and weight will be done with each echocardiogram; blood pressure at clinic visits during treatment with trastuzumab, type of cancer will be noted, type of chemotherapy, doses of chemotherapy, type and dose of chemotherapy in the past, type and dose of radiation therapy received, names and doses of cardiac medications, results of cardiac tests, results of lab tests, family history of heart disease, and social history which will include risk factors for developing heart disease including tobacco and alcohol use. This information will be entered into a database for the investigators to try and detect any factors that may lead to the cardiotoxicity (heart problem) that may be caused by Trastuzumab (Herceptin).
Any transthoracic echocardiogram (heart ultrasound) ordered will be further evaluated for special parameters that may help to detect weakening of the heart earlier than a normal ultrasound. An echocardiogram (heart ultrasound) is when a probe is placed on the chest and pictures are taken using sound waves and a special camera.
- Conditions
- Her 2 Positive Breast Cancer
- Being tested
- Transthoracic echocardiogram (ultrasound)
- Keywords
- Her 2 Positive Breast Cancer, Trastuzumab, Herceptin, Heart Failure, Echocardiography
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic echocardiogram (ultrasound)Procedure or surgery
Also called Transthoracic echocardiogram
Any transthoracic echocardiogram (ultrasound) of the heart, performed as part of standard clinical care, will be further evaluated for special parameters that may help to detect weakening.
| Study group | Role | What they receive |
|---|---|---|
| Transthoracic echocardiogram (ultrasound) | Any transthoracic echocardiogram (ultrasound) of the heart, performed as part of standard clinical care, will be further evaluated for special parameters that may help to detect weakening. Receives: Procedure: Transthoracic echocardiogram (ultrasound) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal Strain
Each transthoracic echocardiogram obtained during the patient's treatment will be assessed for longitudinal strain.
Measured: Change in baseline longitudinal strain from beginning of study to end of study. Patients will be followed for a minimum of 1 year.
Left Ventricular Ejection Fraction
Left ventricular ejection fraction from all clinically indicated transthoracic echocardiograms will be compared from baseline through the end of the study.
Measured: Change in ejection fraction from baseline to end of study. Patients will be followed for a minimum of 1 year.
Secondary outcomes (2)
Clinically evident congestive heart failure
Clinically evident congestive heart failure(symptoms of fluid overload such as shortness of breath, dyspnea on exertion, orthopnea or paroxysmal nocturnal dyspnea or physical findings of congestive heart failure such as jugular venous distension, rales on pulmonary exam, lower extremity edema).
Measured: From baseline to end of study. Patients will be followed for a minimum of 1 year.
Cardiac medication use
The type and dose of all cardiac medications will be followed from baseline to end of study.
Measured: Baseline to end of study. Patients will be follwed for a minimum of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startSep 2014
- Primary completion28 Oct 2016
- Study completion14 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Her 2 Positive Breast CancerStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Cohort
- Time perspective
- Other
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Hamburger, DO, MPH, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080390
- Sponsor's protocol ID
- IRB201300763
- Status last verified
- Feb 2019
- First submitted
- 27 Feb 2014
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strain Imaging in Breast Cancer Patients Receiving Trastuzumab
- ClinicalTrials.gov ID
- NCT02080390
- Acronym / sponsor ID
- IRB201300763
- Conditions
- Her 2 Positive Breast Cancer
- Keywords
- Her 2 Positive Breast Cancer, Trastuzumab, Herceptin, Heart Failure, Echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- 28 Oct 2016 (actual)
- Study completion
- 14 Feb 2019 (actual)
- First posted
- 6 Mar 2014 (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 purpose of this research study is to evaluate the effects of the chemotherapeutic drug, Trastuzumab (Herceptin) on the heart. Trastuzumab (Herceptin) is used to treat specific types of breast cancer and is known to cause weakening of the heart. Unfortunately, little is know as to why this this happens. The investigators want to identify any factors that may lead to the early detection, treatment and prevention of the cardiotoxicity (heart problem) associated with this drug.
Detailed description
As a subject participating in this study the following information will be collected: complete past medical history including age, height, and weight will be done with each echocardiogram; blood pressure at clinic visits during treatment with trastuzumab, type of cancer will be noted, type of chemotherapy, doses of chemotherapy, type and dose of chemotherapy in the past, type and dose of radiation therapy received, names and doses of cardiac medications, results of cardiac tests, results of lab tests, family history of heart disease, and social history which will include risk factors for developing heart disease including tobacco and alcohol use. This information will be entered into a database for the investigators to try and detect any factors that may lead to the cardiotoxicity (heart problem) that may be caused by Trastuzumab (Herceptin).
Any transthoracic echocardiogram (heart ultrasound) ordered will be further evaluated for special parameters that may help to detect weakening of the heart earlier than a normal ultrasound. An echocardiogram (heart ultrasound) is when a probe is placed on the chest and pictures are taken using sound waves and a special camera.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transthoracic echocardiogram (ultrasound) | – | Procedure: Transthoracic echocardiogram (ultrasound)Any transthoracic echocardiogram (ultrasound) of the heart, performed as part of standard clinical care, will be further evaluated for special parameters that may help to detect weakening. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women or men recieveing Trastuzumab (Herceptin) for HER2 positive breast cancer.
Key inclusion criteria (4 listed)
- Age greater than 18 years
- Her 2 positive breast cancer.
- Patients who are currently receiving Trastuzumab (Herceptin).
- Patients who received Trastuzumab (Herceptin) after the formation of the UFHealth Medical Plaza pharmacy database was initiated.
Key exclusion criteria (3 listed)
- Age less than 18 years
- Patients who have not received Trastuzumab (Herceptin).
- Patients who received Trastuzumab prior to the formation of the UFHealth Medical Plaza pharmacy database.
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 |
|---|---|---|
| Transthoracic echocardiogram (ultrasound)Also: Transthoracic echocardiogramAny transthoracic echocardiogram (ultrasound) of the heart, performed as part of standard clinical care, will be further evaluated for special parameters that may help to detect weakening. | Procedure or surgery | Transthoracic echocardiogram (ultrasound) |
Primary outcome
Longitudinal Strain
Time frame: Change in baseline longitudinal strain from beginning of study to end of study. Patients will be followed for a minimum of 1 year.
Each transthoracic echocardiogram obtained during the patient's treatment will be assessed for longitudinal strain.
Left Ventricular Ejection Fraction
Time frame: Change in ejection fraction from baseline to end of study. Patients will be followed for a minimum of 1 year.
Left ventricular ejection fraction from all clinically indicated transthoracic echocardiograms will be compared from baseline through the end of the study.
2 secondary outcomes
Clinically evident congestive heart failure
Time frame: From baseline to end of study. Patients will be followed for a minimum of 1 year.
Cardiac medication use
Time frame: Baseline to end of study. Patients will be follwed for a minimum of 1 year.
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 1 Mar 2019.
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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.
Robert Hamburger, DO, MPH principal investigator
University of Florida
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 Her 2 Positive Breast Cancer, run by University of Florida 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 4 inclusion and 3 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 1 Mar 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?
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?
Longitudinal Strain (time frame: Change in baseline longitudinal strain from beginning of study to end of study. Patients will be followed for a minimum of 1 year.). The study lists 2 primary outcomes in all. 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 Mar 2019.