Side Effects Involving the Heart in Women With Breast Cancer Receiving Doxorubicin and Trastuzumab
This study is currently recruiting participants.
Verified June 2013 by Vanderbilt University
Sponsor:
Vanderbilt University
Collaborator:
Information provided by (Responsible Party):
Douglas Brian Sawyer, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00875238
First received: April 2, 2009
Last updated: June 11, 2013
Last verified: June 2013
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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 Cardiac Effects of Breast Cancer Therapy |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00875238
Contacts
| Contact: Daniel Lenihan, MD | 615-936-0335 |
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 | Recruiting |
| Nashville, Tennessee, United States, 37232-6838 | |
| Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480 | |
| Contact: Daniel Lenihan, MD,PhD 615-322-2318 daniel.lenihan@vanderbilt.edu | |
| Vanderbilt Heart One Hundred Oaks | Recruiting |
| Nashville, Tennessee, United States, 37204 | |
| Contact: Daniel Lenihan, MD 615-322-2318 daniel.lenihan@vanderbilt.edu | |
| Contact: Douglas Sawyer, MD, PhD 615-322-2318 douglas.b.sawyer@vanderbilt.edu | |
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: | June 11, 2013 |
| 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 |
Trastuzumab Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013