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Side Effects Involving the Heart in Women With Breast Cancer Receiving Doxorubicin and Trastuzumab (PACE in BC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00875238
Recruitment Status : Unknown
Verified December 2014 by Douglas Brian Sawyer, Vanderbilt University.
Recruitment status was:  Recruiting
First Posted : April 3, 2009
Last Update Posted : December 2, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
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

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predicting Adverse Cardiac Events in Breast Cancer Therapy (PACE in Breast Cancer)
Study Start Date : June 2008
Estimated Primary Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Change in cardiac function by echocardiogram [ Time Frame: 5 years ]
    change in cardiac function as measured by serial echocardiograms


Secondary Outcome Measures :
  1. Overall feasibility [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
Serum, Plasma, Mononuclear Cells

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Persons with newly diagnosed breast cancer with planned anthracycline-based chemotherapy.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00875238


Contacts
Contact: Daniel Lenihan, MD 615-936-0335

Locations
United States, Kentucky
University of Louisville James Graham Brown Cancer Center Recruiting
Louisville, Kentucky, United States, 40202
Contact: Carrie G. Lenneman, MD, MSCI    502-852-7959    carrie.lenneman@louisville.edu   
Principal Investigator: Carrie G. Lenneman, MD, MSCI         
Sub-Investigator: Elizabeth C. Riley, MD         
Sub-Investigator: Dharamvir Jain, MD         
United States, Tennessee
Vanderbilt Heart One Hundred Oaks Active, not recruiting
Nashville, Tennessee, United States, 37204
MBCCOP - Meharry Medical College - Nashville Active, not recruiting
Nashville, Tennessee, United States, 37208
Vanderbilt-Ingram Cancer Center Active, not recruiting
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Carrie G Lenneman, MD, MSCI Vanderbilt-Ingram Cancer Center & Univ. of Louisville
Principal Investigator: Daniel Lenihan, MD Vanderbilt University
Principal Investigator: Douglas B Sawyer, MD, PhD Vanderbilt University
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Douglas Brian Sawyer, Professor of Medicine, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00875238     History of Changes
Other Study ID Numbers: CDR0000613213
P30CA068485 ( U.S. NIH Grant/Contract )
VU-VICC-BRE-0767
First Posted: April 3, 2009    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: December 2014

Keywords provided by Douglas Brian Sawyer, Vanderbilt University:
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
Cardiotoxicity
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries
Doxorubicin
Liposomal doxorubicin
Trastuzumab
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action