BRCA1 Protein Expression in Patients With Metastatic Breast Cancer Receiving Pegylated Liposomal Doxorubicin Hydrochloride

Inclusion Criteria

• Metastatic breast cancer and have formalin-fixed, paraffin–embedded primary tumor available for testing BRCA1 protein expression
• Have resolution of all acute toxic effects of any prior chemotherapy or radiotherapy to National Cancer Institute Common Terminology Criteria (NCI CTC) grade =< 1 prior to study registration
• Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study specific screening procedures
• Be willing and able to comply with the treatment plan, scheduled clinic visits, laboratory and oncological tests and other study procedures
• Have a Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Measurable disease by computed tomography (CT) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 to evaluate response
• Platelets >= 100 X 10^9 cells/L
• Neutrophils >= 1.5 x 10^9 cells/L
• White blood cells (WBC) >= 3.0 x 10^9 cells/L
• Hemoglobin >= 90 gm/L
• Creatinine < 1.5 mg/dl or creatinine clearance > 40 ml/min
• Aspartate aminotransferase (AST) and/ or alanine aminotransferase (ALT) should be =< 2 x upper limit of normal (ULN, defined as per laboratory where blood testing is done)
• Total bilirubin =< 1.5 x ULN (except for patients with liver metastases, ALT and/or ALT =< 5 times the upper limit of normal is accepted)

Exclusion Criteria

• Myocardial infarction within 6 months of registration
• Brain metastases unless documented to be controlled post completion of local therapy (surgery and/or radiation therapy) for at least four weeks prior to registration
• Pregnant or breast feeding women; women with child bearing potential must use effective measures to prevent pregnancy while receiving pegylated liposomal doxorubicin
• Have a concurrent active non-breast malignancy except for non-melanoma skin cancer
• Human growth factor receptor 2 (HER2) positive tumors as defined by Food and Drug Administration (FDA) guidelines (3+ immunohistochemical staining, defined as uniform, intense membrane staining of more than 10% of invasive tumor cells, and for cases with 2+ staining showing gene amplification by fluorescence in situ hybridization [FISH], expressed as a ratio of more than 2 when comparing HER-2 gene and chromosome 17 fluorescent signals)