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

NCT00875238 | Completed DMC

• 3 other identifiers: CDR0000613213P30CA068485VU-VICC-BRE-0767
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 4

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.

Conditions

Breast Cancer; Cardiac Toxicity; Cardiovascular Complications

Keywords

cardiac toxicity; cardiovascular complications; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

Outcome Measures

Primary Outcomes (1)

• Change in cardiac function by echocardiogram

  change in cardiac function as measured by serial echocardiograms

  5 years

Secondary Outcomes (1)

• Overall feasibility

  3 years

Interventions

trastuzumab BIOLOGICAL

doxorubicin hydrochloride DRUG

polymorphism analysis GENETIC

laboratory biomarker analysis OTHER

questionnaire administration OTHER

assessment of therapy complications PROCEDURE

magnetic resonance imaging PROCEDURE

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Persons with newly diagnosed breast cancer with planned anthracycline-based chemotherapy.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vanderbilt University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

University of Louisville James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Vanderbilt Heart One Hundred Oaks

Nashville, Tennessee, 37204, United States

Location

MBCCOP - Meharry Medical College - Nashville

Nashville, Tennessee, 37208, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Related Publications (2)

• Geisberg CA, Abdallah WM, da Silva M, Silverstein C, Smith HM, Abramson V, Mayer I, Means-Powell J, Freehardt D, White B, Lenihan D, Sawyer DB. Circulating neuregulin during the transition from stage A to stage B/C heart failure in a breast cancer cohort. J Card Fail. 2013 Jan;19(1):10-5. doi: 10.1016/j.cardfail.2012.11.006.

  PMID: 23273589 RESULT

• Lenneman CG, Abdallah WM, Smith HM, Abramson V, Mayer IA, Silverstein C, Silverstein C, Means-Powell J, Paranjape SY, Lenihan D, Sawyer DB, Raj SR. Sympathetic nervous system alterations with HER2+ antagonism: an early marker of cardiac dysfunction with breast cancer treatment? Ecancermedicalscience. 2014 Jul 17;8:446. doi: 10.3332/ecancer.2014.446. eCollection 2014.

  PMID: 25114718 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum, Plasma, Mononuclear Cells

MeSH Terms

Conditions

Breast Neoplasms; Cardiotoxicity

Interventions

Trastuzumab; Doxorubicin; Amplified Fragment Length Polymorphism Analysis; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; DNA Fingerprinting; Genetic Techniques; Investigative Techniques; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2009
• First Posted: April 3, 2009
• Study Start: June 1, 2008
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: February 19, 2018

Record last verified: 2018-02

Locations

US (4)