Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Celgene
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Confirmed adenocarcinoma of the breast
Tumor shows 3+ overexpression of the human epidermal growth factor receptor 2 (HER-2)/proto-oncogene by immunohistochemistry assay, or is fluorescence in situ hybridization (FISH)+
Stage IV disease
Measurable disease
At least 3 weeks since prior cytotoxic chemotherapy
At least 4 weeks since radiotherapy with full recovery
At least 4 weeks since major surgery with full recovery
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
At least 18 years old
Absolute neutrophil count (ANC) at least 1.5 x 10\^9 cells/L
Platelets at least 100 x 10\^9 cells/L
Hemoglobin at least 9 g/dL
Aspartame aminotransferase (AST), alanine aminotransferase (ALT) less than 2.5X upper limit normal
Alkaline Phosphatase less than 1.5X upper limit normal
Creatinine less than 1.5 gm/dL
Normal left ventricular ejection fraction
Negative pregnancy test
Agree to use method to avoid pregnancy
Informed Consent is obtained
You may not be if
Up to one regimen of prior neo-adjuvant or adjuvant chemotherapy is allowed. One year since Taxane and Herceptin treatment.
Cumulative life-time dose of doxorubicin is greater than 360 mg/m\^2
Concurrent immunotherapy or hormonal therapy
Parenchymal brain metastases, if present, must be documented to be clinically and radiographically stable for at least 6 months after treatment
Serious intercurrent medical or psychiatric illness, including serious active infection
History of congestive heart failure
History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer
Patients who have received an investigational drug within the previous 3 weeks
Patient is currently enrolled in another clinical study receiving investigational therapies
Pregnant or nursing women
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