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Cardiotoxicity of Cancer Therapy (CCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01173341
Recruitment Status : Active, not recruiting
First Posted : August 2, 2010
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Study Description
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Brief Summary:
The objective of this study is to define the clinical significance of mechanistic biomarkers (including Neuregulin-1Beta) and novel echocardiographic measures of cardiac function in predicting the incident risk of cancer therapy cardiotoxicity.

Condition or disease Intervention/treatment
Breast Cancer Diagnostic Test: Echocardiography Other: Blood Collection Other: Symptoms Questionnaire

Detailed Description:

The overall study objectives are:

  1. To determine the longitudinal relationships between circulating markers, such as Neuregulin (NRG)-1Beta levels and incident risk of adverse cardiovascular outcomes in patients exposed to anthracycline, trastuzumab, or a combination of the two agents. We hypothesize that a sustained increase in NRG-1Beta, indicative of enhanced cardiac stress with exposure to chemotherapeutic agents, is predictive of an increased risk of cardiac dysfunction and heart failure.
  2. To study the single nucleotide polymorphism (SNP)/haplotype variation in pathways of interest, such as the Neuregulin/Epidermal Growth Factor (ErbB) signaling pathway, on incident risk of adverse cardiovascular outcomes. We hypothesize that there will be SNP/haplotypes variations that are associated with incident cardiovascular outcomes.
  3. To determine the longitudinal relationships between novel echocardiographic measures, such as strain and strain rate and incident cardiac dysfunction in patients exposed to anthracycline, trastuzumab, or a combination of the two agents. We hypothesize that early declines in strain and strain rate are predictive of an increased risk of future cardiac dysfunction and heart failure.
  4. To explore the changes in biomarkers such as NRG-1Beta levels and the relationships with novel echocardiographic measures of cardiac function.
  5. To create a biobank as a future resource for additional questions in novel biomarkers and genetics.
  6. To determine the long-term effects of cancer therapy cardiotoxicity by following patients yearly for 5 years after their exposure to cancer therapy, with the option to extend up to an additional 5 years.
Study Design
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Study Type : Observational
Actual Enrollment : 625 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiotoxicity of Cancer Therapy: Mechanisms and Predictors
Actual Study Start Date : July 2010
Estimated Primary Completion Date : April 2029
Estimated Study Completion Date : April 2029

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Subgroup 2
Subgroup2 represents will undergo trastuzumab therapy only
 Diagnostic Test: Echocardiography
Prior to chemotherapy, prior to and after anthracyclines, every 6 weeks during trastuzumab, and yearly for up to 10 years.

Other: Blood Collection
Drawn at first chemo treatment and periodically during treatment (exact schedule varies with clinically ordered treatment plan), then annually for up to 10 years. Blood is banked for future biomarker testing.

Other: Symptoms Questionnaire
Survey collected at first chemotherapy, periodically during therapy (exact schedule determined by clinically ordered treatment regimen), and annually for up to 10 years.
Subgroup 1
Subgroup 1 are anthracycline only treated patients.
 Diagnostic Test: Echocardiography
Prior to chemotherapy, prior to and after anthracyclines, every 6 weeks during trastuzumab, and yearly for up to 10 years.

Other: Blood Collection
Drawn at first chemo treatment and periodically during treatment (exact schedule varies with clinically ordered treatment plan), then annually for up to 10 years. Blood is banked for future biomarker testing.

Other: Symptoms Questionnaire
Survey collected at first chemotherapy, periodically during therapy (exact schedule determined by clinically ordered treatment regimen), and annually for up to 10 years.
Subgroup 3
Subgroup 3 are patients that will undergo trastuzumab therapy with anthracyclines.
 Diagnostic Test: Echocardiography
Prior to chemotherapy, prior to and after anthracyclines, every 6 weeks during trastuzumab, and yearly for up to 10 years.

Other: Blood Collection
Drawn at first chemo treatment and periodically during treatment (exact schedule varies with clinically ordered treatment plan), then annually for up to 10 years. Blood is banked for future biomarker testing.

Other: Symptoms Questionnaire
Survey collected at first chemotherapy, periodically during therapy (exact schedule determined by clinically ordered treatment regimen), and annually for up to 10 years.


Outcome Measures
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Primary Outcome Measures :
  1. Cardiac dysfunction or signs or symptoms of heart failure [ Time Frame: 10 years ]
    Cardiac dysfunction. as defined according to the Cardiac Review and Evaluation Committee (CREC) criteria as a decline in LVEF of 10% to less than 55% without signs or symptoms


Secondary Outcome Measures :
  1. Change in quantitated Left Ventricular Ejection Fraction (LVEF) [ Time Frame: 10 years ]
    Change in LVEF over the course of chemotherapy; incident diastolic dysfunction by echocardiography; the combined endpoint of any incident adverse cardiovascular outcome (arrhythmia, heart failure, systolic dysfunction, or diastolic dysfunction by echo)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects with breast cancer will enter the cohort prior to chemotherapy initiation and be evaluated at baseline and at regular intervals during the first approximately 15 months after chemotherapy is initiated. Furthermore, given that our goals are to grow our understanding of the late effects of these regimens, we will follow patients once yearly after 1st year of exposure to cancer therapy for a total of 5-10 years from when they began treatment.
Criteria

Inclusion Criteria:

  • Age 18 years or older
  • HER-2 positive breast cancer designated to receive trastuzumab chemotherapy with or without prior exposure to anthracycline-based chemotherapy
  • Non-HER-2 positive breast cancer designated to receive treatment with an anthracycline-containing regimen

Exclusion Criteria:

  • Pre-existing cardiomyopathy with a left ventricular ejection fraction of less than 50%.
  • Other contraindications to trastuzumab or anthracycline chemotherapy.
Contacts and Locations
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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): NCT01173341


Locations
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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: Bonnie Ky, MD Abramson Cancer Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01173341    
Other Study ID Numbers: UPCC 09110
First Posted: August 2, 2010    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Chemotherapy-induced cardiotoxicity
Anthracycline
Trastuzumab
Additional relevant MeSH terms:
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Cardiotoxicity
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
 Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries