ABI-007 and Bevacizumab in Treating Women With Recurrent or Metastatic Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as ABI-007, work in different ways stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving ABI-007 together with bevacizumab may kill more tumor cells. PURPOSE: This phase II is studying how well giving ABI-007 together with bevacizumab works in treating women with recurrent or metastatic breast cancer.

Detailed Description
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OBJECTIVES: Primary Determine the activity of paclitaxel albumin-stabilized nanoparticle formulation (ABI-007; Abraxane^®) and bevacizumab, in terms of progression-free survival and response rate, in women with recurrent or metastatic breast cancer. Secondary Determine the toxicity profile of this regimen in these patients. Determine the feasibility of this regimen in these patients. OUTLINE: This is an open-label, pilot study. Patients receive paclitaxel albumin-stabilized nanoparticle formulation (ABI-007; Abraxane^®) IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Official Title
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Phase II Trial of Abraxane Administered on a Weekly Schedule in Combination With Bevacizumab in Metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Biological: bevacizumab
* Drug: paclitaxel albumin-stabilized nanoparticle formulation


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed invasive breast cancer Recurrent or metastatic disease OR locally recurrent disease not amenable to resection with curative intent Measurable or nonmeasurable disease No CNS metastases by CT scan or MRI No HER2-neu-positive tumors Hormone receptor status not specified PATIENT CHARACTERISTICS: Female Menopausal status not specified Performance status 0-1 Absolute neutrophil count ≥ 1,500/mm³ Platelet count > 100,000/mm³ Creatinine < 2.0 mg/dL Bilirubin normal AST ≤ 2 times upper limit of normal (ULN) (5 times ULN if there is known liver involvement) Urine protein:creatinine ratio < 1.0 OR proteinuria < 2+ by urine dipstick OR ≤ 1 g protein on 24-hour urine collection No peripheral neuropathy > grade 1 Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancies within the past 5 years except carcinoma in situ of the cervix, melanoma in situ, or basal cell carcinoma of the skin No inadequately controlled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg and/or diastolic BP > 100 mm Hg on antihypertensive medications No prior hypertensive crisis or hypertensive encephalopathy No New York Heart Association class II-IV congestive heart failure No myocardial infarction or unstable angina within the past 6 months No stroke or transient ischemic attack within the past 6 months No significant vascular disease (e.g., aortic aneurysm or aortic dissection) No symptomatic peripheral vascular disease No evidence of bleeding diathesis or coagulopathy No significant traumatic injury within the past 28 days No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months No serious, nonhealing wound, ulcer, or bone fracture No known hypersensitivity to any component of bevacizumab PRIOR CONCURRENT THERAPY: No prior paclitaxel albumin-stabilized nanoparticle formulation (ABI-007; Abraxane^®) or bevacizumab No prior chemotherapy for metastatic disease Prior hormonal therapy for metastatic disease allowed At least 4 weeks since any prior therapy for cancer More than 12 months since prior adjuvant chemotherapy, including use of a taxane More than 28 days since prior major surgery or open biopsy More than 7 days since prior core biopsy or minor surgery (excluding placement of a vascular access device) No concurrent major surgery No other concurrent therapy for breast cancer Concurrent bisphosphonates allowed if there is bone involvement No concurrent prophylactic granulocyte colony-stimulating factors

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: bevacizumab|nan|
|Drug: paclitaxel albumin-stabilized nanoparticle formulation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival as measured by RECIST criteria at 1 and 2 years |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate measured every 3 courses during treatment |  |  | 
| Overall survival |  |  | 
| Time to progression |  |  | 
| Disease-free survival |  |  | 
| Toxicity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent breast cancer, stage IV breast cancer