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Early Predictor of Herceptin Cardio Toxicity in Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT02062983
Recruitment Status : Suspended (Difficulty in enrolling patients)
First Posted : February 14, 2014
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
National Guard Health Affairs

Brief 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. 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


Condition or disease Intervention/treatment
Breast Cancer Drug: Herceptin

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:

  1. Baseline evaluation of LVEF prior inhibitor of therapy
  2. 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:

  1. A decline with 10% or more in absolute LVEF from a normal base line to 50% or less
  2. a high cumulative dose of Doxorubicin ( > 450 mg/m2 ) and / or;
  3. 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 .


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Predictor of Herceptin Cardio Toxicity in Breast Cancer Patients
Study Start Date : June 2012
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
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.
Drug: Herceptin

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.





Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Determine the incremental diagnostic value of Trop and BNP in predicting incidence of Hem CMP. [ Time Frame: 3 years ]

    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




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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pilot study trying to identify early predictor for developing cardiotoxicity in such patients.
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02062983


Locations
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Saudi Arabia
National Guard Health Affairs
Riyadh, Saudi Arabia, 11426
Sponsors and Collaborators
National Guard Health Affairs

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Responsible Party: National Guard Health Affairs
ClinicalTrials.gov Identifier: NCT02062983     History of Changes
Other Study ID Numbers: Herceptin
First Posted: February 14, 2014    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
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Breast Neoplasms
Cardiotoxicity
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries
Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents