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A Phase II Study of Weekly Versus Every 2-week Versus Every 3-week Administration of ABI-007 (Abraxane) in Combination With Bevacizumab in Women With Metastatic Breast Cancer.

Phase 2
18 Years
Not Enrolling
Breast Neoplasms, Neoplasm Metastasis

Thank you

Trial Information

A Phase II Study of Weekly Versus Every 2-week Versus Every 3-week Administration of ABI-007 (Abraxane) in Combination With Bevacizumab in Women With Metastatic Breast Cancer.

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

- Any prior history of hypertensive crisis or hypertensive encephalopathy.

- History of myocardial infarction or unstable angina within 6 months prior to study

- History of stroke or transient ischemic attack within 6 months prior to study

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The Percentage of Participants Confirmed Complete Response (CR) or Partial Response (PR) Based on Response Evaluation Criteria In Solid Tumors (RECIST v1.0)

Outcome Description:

Using the RECIST response criteria version 1.0, the percent of participants achieving either a complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the investigator assessment of best overall response during study treatment.

Outcome Time Frame:

Up to 43 months

Safety Issue:


Principal Investigator

Andrew Seidman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

February 2006

Completion Date:

March 2011

Related Keywords:

  • Breast Neoplasms
  • Neoplasm Metastasis
  • First Line Metastatic Breast Cancer
  • Breast Neoplasms
  • Neoplasms
  • Neoplasm Metastasis



Memorial Sloan Kettering Cancer Center New York, New York  10021
Swedish Cancer Institute Seattle, Washington  98104
Monmouth Medical Center Long Branch, New Jersey  07740-6395
Hematology Oncology Associates Atlantis, Florida  33462
Front Range Cancer Specialists Fort Collins, Colorado  80528
St. John's Mercy Medical Center Saint Louis, Missouri  63141
Greater Baltimore Medical Center Baltimore, Maryland  21204
Tennessee Cancer Specialists Knoxville, Tennessee  37920
Nebraska Methodist Hospital Omaha, Nebraska  68114
Family Cancer Center Collierville, Tennessee  38017
California Oncology of the Central Valley Fresno, California  93710
Maine Center for Cancer Medicine & Blood Disorders Scarborough, Maine  04074
Florida Cancer Institute New Port Richey, Florida  34652
Little Rock Hematology Oncology Associates Little Rock, Arkansas  72205
Saint Barnabas Medical Center Livingston, New Jersey  07039
Gulfcoast Oncology Associates St. Petersburg, Florida  33705
Oncology Associates of Bridgeport Trumball, Connecticut  06611
Palm Beach Institute of Hematology and Oncology Boynton Beach, Florida  33435
NYU Clinical Cancer Center New York, New York  10016
Harbor View Cancer Center Baltimore, Maryland  21225
Northwest Georgia Oncology Centers, PC Marietta, Georgia  30060
Division of Hematology/Oncology University of Alabama at Birmingham Birmingham, Alabama  
Glendale Memorial Hospital & Health Center Glendale, California  
Memorial Cancer Institute/Breast Cancer Center Hollywood, Florida  33021
Medical Specialist of the Palm Beaches, Inc Lake Worth, Florida  
Peachtree Hematology & Oncology Associates Atlanta, Georgia  
Center of Hope for Cancers and Blood Stockbridge, Georgia  30281
Boston Medical Center Moakley Building, Solomont Center for Hematology & Medical Oncology Boston, Massachusetts  
North Shore Medical Cancer Center Peabody, Massachusetts  01960
Drs. Forte, Schleidere, & Attas, PA Englewood, New Jersey  
Rosewell Park Cancer Institute Elm & Carlton Carlton Building Buffalo, New York  
Beth Israel Comprehensive Cancer Center New York, New York  
Marion L. Shepard Cancer Center Washington, North Carolina  
Medical Oncology Aultman Hospital Canton, Ohio  
Cancer Centers of Southwest Oklahoma Research Lawton, Oklahoma  
Abington Hematology Oncology Willow Grove, Pennsylvania  
TX Oncology, PA Austin, Texas  
South Texas Oncology & Hematology Clinical Research Dept. San Antonio, Texas  
Virginia Commonwealth University Medical Oncology Richmond, Virginia