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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. Identifier: NCT00875238
Recruitment Status : Completed
First Posted : April 3, 2009
Last Update Posted : February 19, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Vanderbilt University Medical Center ( Vanderbilt University )

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

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Study Type : Observational
Actual Enrollment : 133 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
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
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.


  • 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


  • 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


  • See Disease Characteristics
  • No prior anthracycline chemotherapy

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 identifier (NCT number): NCT00875238

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United States, Kentucky
University of Louisville James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
United States, Tennessee
Vanderbilt Heart One Hundred Oaks
Nashville, Tennessee, United States, 37204
MBCCOP - Meharry Medical College - Nashville
Nashville, Tennessee, United States, 37208
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt University
National Cancer Institute (NCI)
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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

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Vanderbilt University Identifier: NCT00875238     History of Changes
Other Study ID Numbers: CDR0000613213
P30CA068485 ( U.S. NIH Grant/Contract )
First Posted: April 3, 2009    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018
Keywords provided by Vanderbilt University Medical Center ( 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:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological