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

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Doxorubicin; Liposomal doxorubicin; Trastuzumab

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