Weekly vs. Every 2 Week vs. Every 3 Week Administration of ABI-007 (Abraxane)/Bevacizumab Combination in Metastatic Breast Cancer
Breast Neoplasms, Neoplasm Metastasis
About this trial
This is an interventional treatment trial for Breast Neoplasms focused on measuring First Line Metastatic Breast Cancer
Eligibility Criteria
Inclusion Criteria: Pathologically confirmed adenocarcinoma of the breast. Stage IV disease Measurable disease Patients must not be a candidate for Herceptin therapy At least 4 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiation portal or there must be pathologic proof of progressive disease within the radiation portal. At least 4 weeks since major surgery, with full recovery. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Female >18 years of age. Patient has the following blood counts at Baseline: Absolute neutrophil count ≥ 1.5 x 10^9cells/L; platelets ≥ 100 x 10^9 cells/L; hemoglobin ≥ 9 g/dL. Patient has the following blood chemistry levels at Baseline: Aspartate transaminase (AST or SGOT), alanine aminotransferase (ALT or SGPT) ≤ 2.5x upper limit of normal range (ULN); total bilirubin ≤ ULN; creatinine ≤ 1.5 mg/dL. If female of childbearing potential, pregnancy test is negative within 72 hours of first dose of study drug. If fertile, the patient agrees to use an effective method to avoid pregnancy for the duration of the study. Informed consent has been obtained. Exclusion Criteria: Prior neo-adjuvant or adjuvant chemotherapy is allowed, and patients must have recovered from the acute toxicity of such therapies. No prior therapy for metastatic disease is allowed. If a taxane was part of the adjuvant regimen, at least 12 months should have passed from completion of taxane regimen to relapse. If a non-taxane-based adjuvant therapy was administered, at least 6 months should have passed from completion to relapse. Concurrent immunotherapy or hormonal therapy. Parenchymal brain metastases, including leptomeningeal involvement. Inadequately controlled hypertension (defined as blood pressure of > 150/100 mmHg) or New York Heart Association (NYHA) Grade 2 or greater congestive heart failure. Any prior history of hypertensive crisis or hypertensive encephalopathy. History of myocardial infarction or unstable angina within 6 months prior to study enrollment. History of stroke or transient ischemic attack within 6 months prior to study enrollment. Significant vascular disease (e.g., aortic aneurysm, aortic dissection). Symptomatic peripheral vascular disease. Evidence of bleeding diathesis or coagulopathy. History of abdominal fistula, gastrointestinal perforation, or intra- abdominal abscess within 6 months prior to study enrollment. Proteinuria at screening as demonstrated by either: - Urine protein:creatinine (UPC) ratio > 1.0 at screening OR - Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible). Known hypersensitivity to any component of bevacizumab. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to first dose. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to first dose, anticipation of need for major surgical procedure during the course of the study. Serious, non-healing wound, ulcer, or bone fracture. Serious intercurrent medical or psychiatric illness, including serious active infection. History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer. Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study. Pregnant or nursing women. Sensory neuropathy of > Grade 1 at baseline.
Sites / Locations
- Division of Hematology/Oncology University of Alabama at Birmingham
- Little Rock Hematology Oncology Associates
- California Oncology of the Central Valley
- Glendale Memorial Hospital & Health Center
- Front Range Cancer Specialists
- Oncology Associates of Bridgeport
- Palm Beach Institute of Hematology and Oncology
- Memorial Cancer Institute/Breast Cancer Center
- Florida Cancer Institute
- Hematology Oncology Associates
- Medical Specialist of the Palm Beaches, Inc
- Gulfcoast Oncology Associates
- Peachtree Hematology & Oncology Associates
- Northwest Georgia Oncology Centers, PC
- Center of Hope for Cancers and Blood
- Maine Center for Cancer Medicine & Blood Disorders
- Greater Baltimore Medical Center
- Harbor View Cancer Center
- Boston Medical Center Moakley Building, Solomont Center for Hematology & Medical Oncology
- North Shore Medical Cancer Center
- St. John's Mercy Medical Center
- Nebraska Methodist Hospital
- Drs. Forte, Schleidere, & Attas, PA
- Saint Barnabas Medical Center
- Monmouth Medical Center
- Rosewell Park Cancer Institute Elm & Carlton Carlton Building
- Beth Israel Comprehensive Cancer Center
- Memorial Sloan Kettering Cancer Center
- NYU Clinical Cancer Center
- Marion L. Shepard Cancer Center
- Medical Oncology Aultman Hospital
- Cancer Centers of Southwest Oklahoma Research
- Abington Hematology Oncology
- Family Cancer Center
- Tennessee Cancer Specialists
- TX Oncology, PA
- South Texas Oncology & Hematology Clinical Research Dept.
- Virginia Commonwealth University Medical Oncology
- Swedish Cancer Institute
- Metropolitan Oncology Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
260 mg/m^2 ABI-007 every 3 weeks
260 mg/m^2 ABI-007 every 2 weeks
130 mg/m^2 ABI-007 weekly
260 mg/m^2 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks
260 mg/m^2 ABI-007 every 2 weeks and 10 mg/kg bevacizumab every 2 weeks
130 mg/m^2 ABI-007 weekly (without a week of 'rest') and 10 mg/kg bevacizumab every 2 weeks