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Cardiotoxicity of Cancer Therapy: Mechanisms and Predictors


N/A
18 Years
N/A
Open (Enrolling)
Female
Subjects With Breast Cancer

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Trial Information

Cardiotoxicity of Cancer Therapy: Mechanisms and Predictors


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Cardiac dysfunction or signs or symptoms of heart failure

Outcome Description:

Cardiac dysfunction. as defined according to the CREC criteria as a decline in LVEF of 10% to less than 55% without signs or symptoms

Safety Issue:

Yes

Authority:

United States: Institutional Review Board

Study ID:

UPCC 09110

NCT ID:

NCT01173341

Start Date:

July 2010

Completion Date:

July 2013

Related Keywords:

  • Subjects With Breast Cancer
  • Breast Neoplasms

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283