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Cardiotoxicity of Cancer Therapy (CCT)

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ClinicalTrials.gov Identifier: NCT01173341
Recruitment Status : Recruiting
First Posted : August 2, 2010
Last Update Posted : September 26, 2016
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief Summary:
The objective of this study is to define the clinical significance of the Neuregulin/ErbB signaling pathway and novel echocardiographic measures of cardiac function in predicting incident risk of chemotherapy cardiotoxicity.

Condition or disease Intervention/treatment
Subjects With Breast Cancer Other: Blood, Echocardiography, and Questionnaire Timepoints for Anthracycline abd Trastuzumab Other: Blood, Echocardiography and Questionnaire for Trastuzumab Other: Blood, Echocardiography and Questionnaire for Anthracycline Regimen

Detailed Description:

The overall study objectives are:

  1. To determine the longitudinal relationships between circulating NRG-1β 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-1β, 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 SNP/haplotype variation in the Neuregulin/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 echocardiographic measures of 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 NRG-1β 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 a total of 5 years after their exposure to cancer therapy.

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiotoxicity of Cancer Therapy: Mechanisms and Predictors
Study Start Date : July 2010
Estimated Primary Completion Date : July 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Trastuzumab
U.S. FDA Resources

Group/Cohort Intervention/treatment
Subroup 2
Subgroup2 represents will undergo trastuzumab therapy only
Other: Blood, Echocardiography, and Questionnaire Timepoints for Anthracycline abd Trastuzumab

Blood Draw is 16 ml at Pre-treatment and 12ml every 6 weeks during therapy Questionnaire is every 6 weeks during therapy.

1 Echo during pre-treatment, 1 Echo after anthracycline/before Trastuzumab, 1 Echo 3 months, 6 months, 9 months and 12 months of Trastuzumab

Other: Blood, Echocardiography and Questionnaire for Trastuzumab
Echo at Pre-Treatment, 3 months, 6 months, 9 months and 12 months Blood Draw 16 ml at Pre-Treatment, 12 ml every 6 weeks during therapy Questionnaire at Pre-Treatment and every 6 weeks during therapy
Subgroup 1
Subgroup 1 are anthracycline only treated patients.
Other: Blood, Echocardiography and Questionnaire for Anthracycline Regimen
Echocardiogram at Pre-anthracycline, Completion of anthracycline and 1 year after anthracycline initiation Blood Draw 16 ml at Pre-anthracycline, 12 ml during anthracycline, completion of anthracycline and 1 year after anthracycline initiation Questionnaire during Pre-anthracycline, during anthracycline, completion of anthracycline and 1 year after anthracycline initiation
Subgroup 3
Subgroup 3 are patients that will undergo trastuzumab therapy with anthracyclines.
Other: Blood, Echocardiography, and Questionnaire Timepoints for Anthracycline abd Trastuzumab

Blood Draw is 16 ml at Pre-treatment and 12ml every 6 weeks during therapy Questionnaire is every 6 weeks during therapy.

1 Echo during pre-treatment, 1 Echo after anthracycline/before Trastuzumab, 1 Echo 3 months, 6 months, 9 months and 12 months of Trastuzumab




Primary Outcome Measures :
  1. Cardiac dysfunction or signs or symptoms of heart failure
    Cardiac dysfunction. as defined according to the CREC criteria as a decline in LVEF of 10% to less than 55% without signs or symptoms


Secondary Outcome Measures :
  1. Change in LVE F
    Change in LVE F 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 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.

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


Contacts
Contact: Bonnie Ky, MD 855-216-0098 PennCancerTrials@emergingmed.com

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Bonnie Ky, MD    855-216-0098    PennCancerTrials@emergingmed.com   
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01173341     History of Changes
Other Study ID Numbers: UPCC 09110
First Posted: August 2, 2010    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Cardiotoxicity
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries
Trastuzumab
Antineoplastic Agents