Cardiotoxicity of Cancer Therapy (CCT)
This study is currently recruiting participants.
Verified February 2013 by Abramson Cancer Center of the University of Pennsylvania
Sponsor:
Abramson Cancer Center of the University of Pennsylvania
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01173341
First received: July 29, 2010
Last updated: February 25, 2013
Last verified: February 2013
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Purpose
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 | Intervention |
|---|---|
|
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 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Cardiotoxicity of Cancer Therapy: Mechanisms and Predictors |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Cancer
Drug Information available for:
Trastuzumab
U.S. FDA Resources
Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:
Primary Outcome Measures:
- Cardiac dysfunction or signs or symptoms of heart failure [ Designated as safety issue: Yes ]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:
- Change in LVE F [ Designated as safety issue: Yes ]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)
| Estimated Enrollment: | 250 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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 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 |
Detailed Description:
The overall study objectives are:
- 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.
- 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.
- 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.
- To explore the changes in NRG-1β levels and the relationships with novel echocardiographic measures of cardiac function.
- To create a biobank as a future resource for additional questions in novel biomarkers and genetics.
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
More Information
No publications provided
| Responsible Party: | Abramson Cancer Center of the University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT01173341 History of Changes |
| Other Study ID Numbers: | UPCC 09110 |
| Study First Received: | July 29, 2010 |
| Last Updated: | February 25, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Trastuzumab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013