Breast CancerNCT02062983
Early Predictor of Herceptin Cardio Toxicity in Breast Cancer Patients
An observational study of Breast Cancer, run by National Guard Health Affairs at 1 site in Saudi Arabia.
Trial summary
Early identification of patients at risk for cardiotoxicity represent a primary goal for cardiologist and oncologist From all adjuvant trials echocardiography is ideal for evaluating Left Ventricular function though its operator dependent. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Herceptin
- How many people
- 50 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jun 2012to Aug 2016
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pilot study trying to identify early predictor for developing cardiotoxicity in such patients.
Who may be able to join
- Breast cancer cases with histopathology prove of invasive carcinoma with HER 2 over expression detected by immunochemical stain and/ or FISH.
- Age 18 to 80 years old. Patient with above criteria and eligible for Neu adjuvant/ adjuvant /metastatic( Trastuzumab) Herceptin therapy.
- Normal blood count, liver function test and kidney function.
Who cannot join
- Abnormal cardio vascular disease (ex. Heart Failure, Ischemic Heart Disease, post CABG) with EF≤50.
- Valvular abnormality with reduced ejection fraction (EF). Recent Myocardiac Infraction / Ischemia Pregnancy or Breast feeding
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
National Guard Health Affairs
Riyadh, Riyadh Region, 11426
About this study
Early identification of patients at risk for cardiotoxicity represent a primary goal for cardiologist and oncologist
From all adjuvant trials echocardiography is ideal for evaluating Left Ventricular function though its operator dependent. The use of other technique such as endomyocardial biopsy, is troublesome in clinical practice
Cardiac magnetic resonance imaging (MRI) have greater reproducibility in evaluating left ventricular ejection fraction (LVEF). This technique provides morphological, functional, perfusion, and viability information in one assessment. It is expensive and time consuming but id the diagnostic method of choice for patients with technically limited images from ECG and in patients with discordant information that is clinically significant from prior tests
Read the detailed description
Current standard of care for patients while on adjuvant trastuzumab is baseline ECHO are as follows:
Patients on one of the above medications should undergo regular monitoring of the heart function during treatment as the following:
- Baseline evaluation of LVEF prior inhibitor of therapy
- Serial assessment of LVEF using the same modality.
There is no clear international guidelines on the frequency and method of LVEF assessment.
Cardiac function is usually measured by using (ECHO) echo cardiography and multiple-gated acquisition (MUGA) The patient should be assessed with the same techniques during treatment to avoid stressing the myocardium by the use of exercise or ionotropic agent, before measuring LVEF to prevent earlier evidence of cardiotoxicity. Changes in the early atrial (E/A) filling ratio reflect ventricular compliance and may predict diastolic dysfunction and so decline in LVEF.
Diastolic dysfunction seems to be predictive of cardiac morbidity and mortality.
Trials with adjuvant trastuzumab use the rules for stopping cardiotoxic agents. They identified subset of high risk patients by one or two of the following three criteria:
- A decline with 10% or more in absolute LVEF from a normal base line to 50% or less
- a high cumulative dose of Doxorubicin ( > 450 mg/m2 ) and / or;
- abnormal baseline LVEF < 50% Patients who stopped taking doxorubicin after an LVEF decline were less likely to develop congestive heart failure (CHF) than those who did not.
Echocardiography is used regularly to monitor LVEF and is more widely available. The MUGA, in addition it does not expose patients to ionizing radiation but it is operator-dependent but training and use of automation may overcome the variation .
- Conditions
- Breast Cancer
- Being tested
- 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.
HerceptinDrug
Herceptin will be administered in different way per each setting as follow::total herceptin cycles are 18.
Neu Adjuvant : chemo+herceptin, Surgery (hold herceptin) , Resume herceptin for 1 year period Adjuvant : Surgery, chemo+herceptin for 1 year period Metastatic : chemo+herceptin until progression.
| Study group | Role | What they receive |
|---|---|---|
| Herceptin | The study will be carried in prospective manner enrolling all patients diagnosed with breast cancer and over expressed human epidermal growth factor receptor 2 (HER2) and they are requiring Trastuzumab Neu adjuvant/ adjuvant /metastatic therapy as per standard care. Receives: Drug: Herceptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the incidence /of Herceptin induced heart failure in our population
To evaluate the reversibility of damage in patients on long term follow- up for a period of up to three years.
To identify the applicability of troponin / cardiac natriuretic peptides (CNPS) as bio marker that can predict the occurrence of clinically significant left ventricular dysfunction.
To evaluate the role of MRI in identifying patient at risk to develop cardio toxicity.
Determine the frequency of elevated Troponin and B-type natriuretic peptide (BNP) in patient receiving adjuvant herceptin.
Measured: 3 years
Secondary outcomes (1)
Determine the incremental diagnostic value of Trop and BNP in predicting incidence of Hem CMP.
Determine the incremental diagnostic value of Trop and BNP in predicting incidence of Hem cardiac marker (CMP).
Determine the relation between prior myocardial scaling and incidence of herceptin induced cardiac marker (CMP).
Determine the correlation between myocardial edema, BNP and heart failure incidence of CMP
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startJun 2012
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Why it stopped: Difficulty in enrolling patients
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.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Guard Health Affairs
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062983
- Sponsor's protocol ID
- Herceptin
- Status last verified
- May 2016
- First submitted
- 23 Jan 2014
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Predictor of Herceptin Cardio Toxicity in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT02062983
- Acronym / sponsor ID
- Herceptin
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Difficulty in enrolling patients
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Guard Health AffairsOther government
- Study start
- Jun 2012
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 14 Feb 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.
Early identification of patients at risk for cardiotoxicity represent a primary goal for cardiologist and oncologist
From all adjuvant trials echocardiography is ideal for evaluating Left Ventricular function though its operator dependent. The use of other technique such as endomyocardial biopsy, is troublesome in clinical practice
Cardiac magnetic resonance imaging (MRI) have greater reproducibility in evaluating left ventricular ejection fraction (LVEF). This technique provides morphological, functional, perfusion, and viability information in one assessment. It is expensive and time consuming but id the diagnostic method of choice for patients with technically limited images from ECG and in patients with discordant information that is clinically significant from prior tests
Detailed description
Current standard of care for patients while on adjuvant trastuzumab is baseline ECHO are as follows:
Patients on one of the above medications should undergo regular monitoring of the heart function during treatment as the following:
- Baseline evaluation of LVEF prior inhibitor of therapy
- Serial assessment of LVEF using the same modality.
There is no clear international guidelines on the frequency and method of LVEF assessment.
Cardiac function is usually measured by using (ECHO) echo cardiography and multiple-gated acquisition (MUGA) The patient should be assessed with the same techniques during treatment to avoid stressing the myocardium by the use of exercise or ionotropic agent, before measuring LVEF to prevent earlier evidence of cardiotoxicity. Changes in the early atrial (E/A) filling ratio reflect ventricular compliance and may predict diastolic dysfunction and so decline in LVEF.
Diastolic dysfunction seems to be predictive of cardiac morbidity and mortality.
Trials with adjuvant trastuzumab use the rules for stopping cardiotoxic agents. They identified subset of high risk patients by one or two of the following three criteria:
- A decline with 10% or more in absolute LVEF from a normal base line to 50% or less
- a high cumulative dose of Doxorubicin ( > 450 mg/m2 ) and / or;
- abnormal baseline LVEF < 50% Patients who stopped taking doxorubicin after an LVEF decline were less likely to develop congestive heart failure (CHF) than those who did not.
Echocardiography is used regularly to monitor LVEF and is more widely available. The MUGA, in addition it does not expose patients to ionizing radiation but it is operator-dependent but training and use of automation may overcome the variation .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Herceptin | – | Drug: HerceptinThe study will be carried in prospective manner enrolling all patients diagnosed with breast cancer and over expressed human epidermal growth factor receptor 2 (HER2) and they are requiring Trastuzumab Neu adjuvant/ adjuvant /metastatic therapy as per standard care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pilot study trying to identify early predictor for developing cardiotoxicity in such patients.
Key inclusion criteria (3 listed)
- Breast cancer cases with histopathology prove of invasive carcinoma with HER 2 over expression detected by immunochemical stain and/ or FISH.
- Age 18 to 80 years old. Patient with above criteria and eligible for Neu adjuvant/ adjuvant /metastatic( Trastuzumab) Herceptin therapy.
- Normal blood count, liver function test and kidney function.
Key exclusion criteria (2 listed)
- Abnormal cardio vascular disease (ex. Heart Failure, Ischemic Heart Disease, post CABG) with EF≤50.
- Valvular abnormality with reduced ejection fraction (EF). Recent Myocardiac Infraction / Ischemia Pregnancy or Breast feeding
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 |
|---|---|---|
| HerceptinHerceptin will be administered in different way per each setting as follow::total herceptin cycles are 18. Neu Adjuvant : chemo+herceptin, Surgery (hold herceptin) , Resume herceptin for 1 year period Adjuvant : Surgery, chemo+herceptin for 1 year period Metastatic : chemo+herceptin until progression. | Drug | Herceptin |
Primary outcome
Estimate the incidence /of Herceptin induced heart failure in our population
Time frame: 3 years
To evaluate the reversibility of damage in patients on long term follow- up for a period of up to three years. To identify the applicability of troponin / cardiac natriuretic peptides (CNPS) as bio marker that can predict the occurrence of clinically significant left ventricular dysfunction. To evaluate the role of MRI in identifying patient at risk to develop cardio toxicity. Determine the frequency of elevated Troponin and B-type natriuretic peptide (BNP) in patient receiving adjuvant herceptin.
1 secondary outcome
Determine the incremental diagnostic value of Trop and BNP in predicting incidence of Hem CMP.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Breast Cancer, run by National Guard Health Affairs at 1 site in Saudi Arabia.
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 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: paused, as of the sponsor's last update on 13 May 2016. 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 Saudi Arabia. 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?
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?
Estimate the incidence /of Herceptin induced heart failure in our population (time frame: 3 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 13 May 2016.