OGX-011 and Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed breast cancer
• * Metastatic or locally advanced disease
• * Not curable with standard therapy
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• * Lesion must be outside of the previously irradiated field
• * If the sole site of disease is in a previously irradiated field, there must be evidence of disease progression or new lesions in the irradiated field
• No known CNS metastases
• Hormone receptor status:
• * Not specified
• PATIENT CHARACTERISTICS:
• Sex
• Female
• Menopausal status
• Not specified
• Performance status
• ECOG 0-2
• Life expectancy
• At least 12 weeks
• Hematopoietic
• Platelet count ≥ 100,000/mm\^3
• Absolute granulocyte count ≥ 1,500/mm\^3
• PTT, PT, and INR normal
• No known bleeding disorder
• Hepatic
• Bilirubin normal
• AST and ALT ≤ 1.5 times upper limit of normal (ULN)
• Renal
• Creatinine ≤ 1.5 times ULN
• Cardiovascular
• No significant cardiac dysfunction
• Immunologic
• No active uncontrolled infection
• No history of serious allergic reaction to taxanes, including paclitaxel or docetaxel
• Other
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No preexisting neuropathy ≥ grade 2
• No other malignancies within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix
• No other serious medical condition or illness that would preclude study participation
• No significant neurological disorder that would preclude giving informed consent
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• Prior trastuzumab (Herceptin\^®) allowed
• Chemotherapy
• Recovered from prior chemotherapy
• At least 6 months since prior adjuvant chemotherapy (taxanes allowed)
• At least 4 weeks since prior chemotherapy for advanced disease
• * No prior taxanes for advanced disease
• No more than 1 prior chemotherapy regimen for advanced disease
• No other concurrent chemotherapy
• Endocrine therapy
• At least 1 week since prior hormonal therapy
• Radiotherapy
• See Disease Characteristics
• At least 4 weeks since prior radiotherapy
• * Low-dose, nonmyelosuppressive radiotherapy allowed within 4 weeks before study entry at the discretion of the investigator
• No prior radiotherapy ≥ 30% of functioning bone marrow
• No concurrent radiotherapy
• Surgery
• At least 3 weeks since prior major surgery and recovered (wound healing must have occurred)
• Other
• More than 4 weeks since prior investigational agents or new anticancer therapy
• No concurrent therapeutic anticoagulation therapy except low-dose oral anticoagulant therapy (i.e., 1 mg of oral warfarin once a day) or low molecular weight heparin
• No other concurrent investigational therapy
• No other concurrent cytotoxic therapy