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Side Effects Involving the Heart in Women With Breast Cancer Receiving Doxorubicin and Trastuzumab

This study is currently recruiting participants.
Verified March 2010 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00875238
First received: April 2, 2009
Last updated: March 13, 2010
Last verified: March 2010
History of Changes
  Purpose

RATIONALE: Studying samples of blood and tissue in the laboratory from women receiving doxorubicin and trastuzumab for breast cancer may help doctors learn more about changes that occur in DNA and identify biomarkers for increased risk of cardiac effects.

PURPOSE: This clinical trial is studying side effects involving the heart in women with breast cancer receiving doxorubicin and trastuzumab.


Condition Intervention
Breast Cancer
Cardiac Toxicity
Cardiovascular Complications
 Biological: trastuzumab
Drug: doxorubicin hydrochloride
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Other: questionnaire administration
Procedure: assessment of therapy complications
Procedure: magnetic resonance imaging

Study Type: Observational
Official Title: Predicting Cardiac Effects of Breast Cancer Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Cardiac toxicity according to NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Change in cardiac function by echocardiogram [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall feasibility [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2008
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosed with breast cancer

    • Receiving treatment at Vanderbilt Ingram Cancer Center and other participating oncology practices in middle Tennessee and southern Kentucky

  • Starting a standard doxorubicin hydrochloride regimen for 4 courses

    • Also scheduled to receive trastuzumab (for patients enrolled in sub-study B only)
  • No presence of metastatic disease
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • Karnofsky performance status 60-100%
  • Not pregnant
  • Negative pregnancy test

  • Additional criteria for sub-study A (MRI):

    • Glomerular filtration rate ≥ 60 mL/min
    • No implanted electronic devices, cochlear implants, metallic implants, shrapnel or neurosurgical clips
    • No prior adverse reaction to gadolinium-based contrast agents
    • Must not exceed the weight limit or be too large to fit in the MRI scanner

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior anthracycline chemotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00875238

Locations
United States, Tennessee
MBCCOP - Meharry Medical College - Nashville Recruiting
Nashville, Tennessee, United States, 37208
Contact: Contact Person     615-327-6000        
Vanderbilt-Ingram Cancer Center - Cool Springs Recruiting
Nashville, Tennessee, United States, 37064
Contact: Carrie Geisberg     936-4720        
Vanderbilt-Ingram Cancer Center at Franklin Recruiting
Nashville, Tennessee, United States, 37064
Contact: Douglas Sawyer     615-591-9890        
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center     800-811-8480        
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Douglas B. Sawyer, MD, PharmD Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Douglas B. Sawyer, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00875238     History of Changes
Other Study ID Numbers: CDR0000613213, VU-VICC-BRE-0767
Study First Received: April 2, 2009
Last Updated: March 13, 2010
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
cardiac toxicity
cardiovascular complications
stage I breast cancer
stage II breast cancer
 stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Doxorubicin
 Trastuzumab
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013