DNA in Predicting Response After Systemic Therapy in Women With Metastatic Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Meets 1 of the following criteria:
• * Histologically and/or cytologically confirmed stage IV adenocarcinoma of the breast (patient)
• * No diagnosis of an abnormal breast biopsy (including atypical ductal or lobular hyperplasia), or new diagnosis of breast cancer or breast cancer recurrence within the past five years (healthy participant)
• Evidence of disease progression AND initiating a new systemic treatment regimen with trastuzumab (Herceptin®), chemotherapy, endocrine therapy, or investigational agent(s) (patient)
• * Treatment may be given as a single agent or in combination
• Measurable or evaluable disease (patient)
• * Measurable disease is defined as ≥ 1 measurable lesion identified by RECIST criteria
• * Patients with evaluable disease only must have ≥ 1 tumor marker (e.g., carcinoembryonic antigen, CA 27-29, or CA 15-3) above normal level
• Treated brain metastases (surgery or radiation therapy) allowed provided patient has evidence of disease stability or presence of other site(s) of measurable or evaluable disease (patient)
• * No leptomeningeal disease
• Hormone receptor status not specified
• PATIENT CHARACTERISTICS:
• Female
• Menopausal status not specified
• ECOG performance status 0-2
• No known cancer within the past 5 years other than basal cell or squamous cell carcinoma of the skin and/or adequately treated cervical cancer (healthy participant)
• Not pregnant or nursing
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• Prior therapy in the preoperative, adjuvant, and/or metastatic setting allowed
• * Any number of prior regimens in any setting allowed
• No prior radiation therapy to the only site of disease unless there is evidence of post-radiation disease progression
• No selective estrogen receptor modulator or aromatase inhibitor for breast cancer prevention or therapy within the past 12 months (healthy participant)
• Prior or concurrent use of raloxifene for osteopenia or osteoporosis therapy allowed (healthy participant)
• Concurrent participation in another clinical trial, including one involving an investigational agent(s), allowed