a trial of 2 schedules of ixabepilone plus bevacizumab and paclitaxel plus bevacizumab for breast cancer

Conditions: Metastatic Breast Cancer

Summary: the purpose of this clinical research study is to learn if ixabepilone plus bevacizumab is effective in shrinking or stopping the growth of cancer when given as first-line chemotherapy in participants with metastatic breast cancer. the study will also assess the safety of this combination treatment.


Eligibility criteria:
inclusion criteria: * locally recurrent or metastatic breast cancer, previously untreated with chemotherapy for advanced disease. * at least 1 target lesion per recist criteria. locally recurrent disease must not be amenable to resection with curative intent. * no previous cytotoxic chemotherapy for locally recurrent/metastatic disease. * relapse 12 months or more after completing prior adjuvant or neoadjuvant taxane therapy. * no previous breast cancer known to overexpress or amplify the human epidermal growth factor receptor 2 gene. * prior hormonal therapy in adjuvant, recurrent, or metastatic setting allowed but must have been discontinued at least 2 weeks before randomization. * karnofsky performance status of 80 to 100 or eastern cooperative oncology group performance status of 0 to 1. * estimated life expectancy of at least 12 weeks. * recovery from recent therapy (except for alopecia), including chemotherapy, immunotherapy, biologic therapy, or investigational product. any such therapy must have been completed at least 3 weeks before randomization and at least 6 weeks from use of nitrosourea, or mitomycin. * recovery from recent surgery and radiation therapy. at least 1 week since minor surgery and/or focal/palliative radiation therapy; at least 3 weeks from radiation; at least 4 weeks from major surgery; and at least 8 weeks from liver resection, thoracotomy, or neurosurgery. * absolute neutrophil count ≥1500/mm\^3. * hemoglobin ≥9 g/dl. * platelets ≥100,000/mm\^3. * total bilirubin ≤1.5 times the upper limit of normal (uln). * aspartate aminotransferase or alanine aminotransferase ≤2.5\*uln. * normal partial thromboplastin time and either international normalized ratio or prothrombin time \<1.5\*uln. * serum creatinine ≤1.5\*uln or 24-hour creatinine clearance \>60 ml/min. * urine dipstick for proteinuria \<2+ (negative, trace, or +1). participants with ≥2+ proteinuria at baseline were to undergo 24-hour urine collection and demonstrate ≤1g of protein in 24 hours to be eligible. exclusion criteria: * women of child-bearing potential (wocbp) unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and up to 6 months after treatment with bevacizumab. * women who were pregnant or breastfeeding. * women with a positive pregnancy test on enrollment or prior to study drug administration. * sexually active fertile men, whose partners were wocbp, not using an adequate method of birth control. * evidence of baseline sensory or motor neuropathy. * serious infection or nonmalignant medical illnesses uncontrolled or the control of which could be jeopardized by this therapy. * history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, serious gastric ulcer, or bone fracture within 6 months of study entry. * history of hypertensive crisis or hypertensive encephalopathy. * significant vascular disease. * clinically significant cardiovascular disease. * baseline left ventricular ejection fraction by multiple-gated acquisition scan or echocardiogram for subjects with prior exposure to anthracyclines not within institutional normal limits. * symptomatic peripheral vascular disease. * history of high dose chemotherapy with bone marrow transplant or peripheral blood stem cell transplant within the previous 2 years. * evidence of bleeding diathesis or coagulopathy. * prior treatment with an epothilone or any antiangiogenic agent. * concurrent nonhealing wound, ulcer, or fracture. * any current or history of brain and/or leptomeningeal metastases. psychiatric disorders or other conditions rendering the participant incapable of complying with the requirements of the protocol. * any concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix. * known allergy to any of the study drugs or their excipients.