A Phase 1-2, XIAP Antisense AEG35156 With Weekly Paclitaxel in Patients With Advanced Breast Cancer

Inclusion Criteria: * Patients with histologically or cytologically confirmed breast adenocarcinoma who are candidates for paclitaxel single agent chemotherapy for metastatic breast cancer * ECOG performance \< 2 * One or more metastatic tumors measurable by RECIST criteria on CT scan or MRI (Phase 2 part only) * Life expectancy of at least 6 months * Age \> 18 years * Signed, written IRB-approved informed consent * A negative serum pregnancy test (if applicable) * Acceptable liver function: * Bilirubin within normal limit * AST (SGOT), ALT (SGPT) and Alkaline phosphatase \< 2.0 times the institution's upper limit of normal * Acceptable renal function: * Serum creatinine within normal limits, OR calculated creatinine clearance \> 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal * Acceptable hematologic status: * Granulocyte \> 1500 cells/uL * Platelet count \> 100,000 plt/uL * Hemoglobin \> 9.0 g/dL * Acceptable coagulation status: * PT within normal limits * PTT within normal limits * For women of child-bearing potential, the use of effective contraceptive methods during the study * Prior radiotherapy is allowed provided disease progression outside the radiation field has been documented, and treatment completed at least 2 weeks prior to registration Exclusion Criteria: * Prior taxane chemotherapy for metastatic disease. * More than one prior chemotherapy regimen for metastatic disease * Active progressive brain metastases including the presence of any related symptoms or need for corticosteroids. A CT or MRI scan of the head is necessary in patients with a history of brain metastases to document the stability of prior lesions * Grade \> 2 peripheral neuropathy * Known bleeding diathesis or concurrent treatment with anticoagulants except patients on non-therapeutic line maintenance coumadin * Pregnant or nursing women. NOTE: Women of child-bearing potential must agree to use adequate contraception (sterile or surgically sterile; hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy * Known infection with HIV, hepatitis B, or hepatitis C * Serious nonmalignant disease that could compromise protocol objectives in the opinion of the investigator and/or the sponsor * Patients who are currently receiving any other investigational agent. Subjects who have used a previous antisense oligonucleotide in the last 90 days will be excluded * Unwillingness or inability to comply with procedures required in this protocol * Any deviation from these inclusion/exclusion criteria must be discussed with the sponsor prior to enrolling patient.