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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Douglas Brian Sawyer, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00875238
First received: April 2, 2009
Last updated: August 5, 2014
Last verified: August 2014
  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
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predicting Adverse Cardiac Events in Breast Cancer Therapy (PACE in Breast Cancer)

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Change in cardiac function by echocardiogram [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    change in cardiac function as measured by serial echocardiograms


Secondary Outcome Measures:
  • Overall feasibility [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum, Plasma, Mononuclear Cells


Estimated Enrollment: 200
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:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875238

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

Additional Information:
Publications:
Responsible Party: Douglas Brian Sawyer, Professor of Medicine, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00875238     History of Changes
Other Study ID Numbers: CDR0000613213, P30CA068485, VU-VICC-BRE-0767
Study First Received: April 2, 2009
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Doxorubicin
Liposomal doxorubicin
Trastuzumab
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014