Correlate BRCA1 Protein Expression With Response to DNA Damaging Chemotherapy

Inclusion Criteria:

- Metastatic breast cancer and have formalin-fixed, paraffin embedded primary tumor
available for testing BRCA1 protein expression

- Adults over 18 years of age

- Have resolution of all acute toxic effects of any prior chemotherapy or radiotherapy
to 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 ECOG performance status of 0 - 2

- Measurable disease by CT by RECIST 1.1 to evaluate response

- Adequate bone marrow function defined as platelets 100 X 109 cells/L, neutrophils 1.5
x 109 cells/L, white blood cells (WBC) 3.0 x 109 cells/L and a hemoglobin 90 gm/L

- Creatinine < 1.5 mg/dl or creatinine clearance > 40 ml/min

- Liver function tests (AST and or 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

- Her2 positive tumors as defined by 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 FISH, expressed as
a ratio of more than 2 when comparing HER-2 gene and chromosome 17 fluorescent
signals)