Cardiotoxicity of Cancer Therapy (CCT)

Abramson Cancer Center at Penn Medicine

Status: Invitation-only

Conditions: Breast Cancer

Treatments: Other: Blood Collection; Diagnostic Test: Echocardiography; Other: Symptoms Questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT01173341

UPCC 09110

Details and patient eligibility

About

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.

Full 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.

Enrollment: 700 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

• Other contraindications to trastuzumab or anthracycline chemotherapy.
• Vulnerable populations

Trial design

700 participants in 3 patient groups

Subgroup 2

Description:

Subgroup2 represents will undergo trastuzumab therapy only

Treatment:

Other: Symptoms Questionnaire

Diagnostic Test: Echocardiography

Other: Blood Collection

Subgroup 1

Description:

Subgroup 1 are anthracycline only treated patients.

Treatment:

Other: Symptoms Questionnaire

Diagnostic Test: Echocardiography

Other: Blood Collection

Subgroup 3

Description:

Subgroup 3 are patients that will undergo trastuzumab therapy with anthracyclines.

Treatment:

Other: Symptoms Questionnaire

Diagnostic Test: Echocardiography

Other: Blood Collection