Early Detection and Prediction of Chemotherapy Induced Cardiac Toxicity in Breast Cancer Patients - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00806507

Purpose

The primary objectives of this study are:

To determine whether tissue Doppler imaging and/or circulating levels of B-type natriuretic peptide, or its byproduct aminoterminal pro-B-type natriuretic peptide, and ultrasensitive troponin are early and sensitive markers of cardiac toxicity in breast cancer patients treated with trastuzumab (Herceptin). We hypothesize that early abnormalities of tissue Doppler imaging and/or natriuretic peptides or troponin will predict a later decrease in left ventricular function.
To test whether metabolic profiling can predict or detect in an early manner treatment-induced cardiac toxicity in breast cancer patients.
To determine whether common HER-2 single nucleotide polymorphisms identify a subgroup of breast cancer patients at high risk developing cardiac toxicity with Herceptin therapy.
To determine whether Herceptin infusion causes acute changes in cardiac function.

Condition	Intervention
Breast Cancer	Procedure: Echocardiograms Procedure: Blood Test

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Early Detection and Prediction of Chemotherapy Induced Cardiac Toxicity in Breast Cancer Patients

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To study whether different ways of viewing echocardiogram pictures along with blood tests can help to see heart-related side effects of chemotherapy and trastuzumab earlier than the usual tests. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	20
Study Start Date:	November 2008
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Echocardiogram + Blood Test	Procedure: Echocardiograms Additional views performed in 5-10 minutes of regularly scheduled echocardiograms. Procedure: Blood Test Measuring of hormones and metabolic proteins (such as sugars and acids).

Detailed Description:

Echocardiogram:

Because of the heart-related side effects of chemotherapy and trastuzumab, your regular doctor will monitor your heart's function as part of your routine care. You will have echocardiograms performed before you begin treatment, and then every 3 months. An echocardiogram uses sound waves to check your heart's health.

If you decide to take part in this study, researchers will take several additional pictures of your heart during each of your regularly scheduled echocardiograms. The additional pictures will make the procedure take about 5-10 minutes longer than the regular echocardiogram. These pictures will be viewed in a different way than the standard echocardiogram pictures. Researchers hope viewing the pictures this way can help researchers to find heart problems earlier than the usual tests.

Blood Tests:

Blood (about 4 teaspoon each time) will be drawn during the routine blood draw that occurs closest to the regularly scheduled echocardiograms.

The heart produces hormones called BNP and NT-proBNP. These hormones can be measured in the blood. BNP and NT-proBNP levels can be higher when the heart is not working as well. Researchers will measure these hormones at the time of each echocardiogram. Researchers hope to learn whether measuring these hormones can help identify the heart-related side effects of chemotherapy and trastuzumab earlier than the usual tests.

Researchers will also measure metabolic proteins (such as sugars and acids) in the blood. Researchers hope to learn whether measuring these metabolic proteins can help identify the heart-related side effects of chemotherapy and trastuzumab earlier than the usual tests.

Because protein, sugar or acid levels may be temporarily changed after you eat, you will be asked not to eat overnight before having your blood drawn.

Study Visits:

You will have 6 study visits around the time that you have an echocardiogram. These visits will occur before you take Herceptin, when you begin Herceptin, and 3, 6, 9, and 12 months later. These study visits will be scheduled on days when you are already making a visit to your regular doctor.

You will not have to make any special visits to the hospital for this research study.

During each study visit, you will be asked about any symptoms you may be experiencing, and any medications you may be taking. Your blood pressure and heart rate will be measured.

Length of Study:

You will be considered off-study once you complete the 6 study visits.

THIS IS AN INVESTIGATIONAL STUDY. Up to 100 patients will take part in this multicenter study. Up to 20 patients will be enrolled at M. D. Anderson.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Breast cancer patients treated with chemotherapy and Herceptin (trastuzumab)

Criteria

Inclusion Criteria:

Age 18 years or older
HER-2 positive breast cancer
Scheduled to receive Herceptin infusion therapy after exposure to anthracycline-based chemotherapy in one of the following manners: Adjunctive treatment for early stage disease with anthracycline-based chemotherapy followed by Herceptin infusion therapy. Herceptin monotherapy in patients with metastatic disease previously treated with anthracycline-based chemotherapy. Herceptin in combination with non-anthracycline chemotherapy in patients with metastatic disease previously treated with anthracycline-based chemotherapy
Normal baseline left ventricular ejection fraction

Exclusion Criteria:

Pre-existing cardiomyopathy (LVEF < 50%)
Other contraindication to Herceptin therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806507

Contacts

Contact: Juan C Plana, MD

713-794-4197

Locations

United States, Massachusetts
Partners Healthcare Systems	Recruiting
Boston, Massachusetts, United States, 02199

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Juan C Plana, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

The University of Texas M.D.Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Juan C. Plana, MD/Assistant Professor )
Study ID Numbers:	2007-0339
Study First Received:	November 20, 2008
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00806507 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Tissue Doppler Imaging
B-type natriuretic peptide
Advia Centaur immunoassay system
GE Vivid ultrasound machine

Roche 2010 system
Echocardiography
Herceptin

Study placed in the following topic categories:

Natriuretic Peptide, Brain
Skin Diseases
Trastuzumab

Breast Neoplasms
Hormones
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on May 06, 2009