Predicting Response and Toxicity in Patients Receiving Paclitaxel and Avastin for Breast Cancer

Exclusion Criteria

• •Patients must not have had chemotherapy for locally recurrent or metastatic breast cancer.
• •Hormonal therapy for locally recurrent or metastatic disease must have been discontinued at least 2 weeks prior to study entry.
• •Patients must not have had adjuvant or neoadjuvant taxane therapy within 12 months prior to study entry.
• •Patients must not have had a major surgical procedure within 4 weeks prior to study entry. (Placement of vascular access device, and breast biopsy, will not be considered major surgery.)
• •Patients must not have had a minor surgical procedure, placement of an access device, or fine needle aspiration within 7 days of starting protocol therapy.
• •Patients must not have had radiation within 2 weeks prior to study entry.
• •Previously radiated area(s) must not be the only site of disease for study entry.
• •Patients must not have a history of bleeding diathesis or have used anticoagulant therapy within 10 days of study entry. (Low dose anticoagulant therapy to maintain patency of a vascular access device is allowed.)
• •Aspirin usage (\> 325 mg/day) or other nonsteroidal anti-inflammatory medications known to inhibit platelet function daily are not allowed within 10 days prior to study entry.
• •Patients must not have a history of TIA or CVA within 6 months prior to study entry.
• •Patients must not have a history or radiologic evidence of CNS metastases including previously treated, resected or asymptomatic brain lesions or leptomeningeal involvement (head CT or MRI must be obtained within 6 weeks prior to study entry).
• •Patients must not have a non-healing wound or fracture.
• •Patients must not have a hypersensitivity to paclitaxel or drugs using the vehicle Cremophor, Chinese hamster ovary cell products or other recombinant human antibodies.
• •Females must not be pregnant or breastfeeding. Females of childbearing potential must use an accepted and effective method of contraception (hormonal or barrier method of birth control; abstinence) while on treatment and for a 3 month period thereafter.
• •Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy. Subjects are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
• •History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study entry
• •Urine protein: creatinine (UPC) ratio \> 1.0 at baseline or urine protein dipstick \> 2+.