A Phase 1-2, Multicenter, Open-Label Study of the X-Linked Inhibitor of Apoptosis (XIAP) Antisense AEG35156 Given in Combination 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.