Back to resultsABI-007 and Bevacizumab in Treating Women With Recurrent or Metastatic Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bevacizumab
paclitaxel albumin-stabilized nanoparticle formulation
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring recurrent breast cancer, stage IV breast cancer
Eligibility Criteria
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
Sites / Locations
- Premiere Oncology
Outcomes
Primary Outcome Measures
Progression-free survival as measured by RECIST criteria at 1 and 2 years
Secondary Outcome Measures
Response rate measured every 3 courses during treatment
Overall survival
Time to progression
Disease-free survival
Toxicity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00404404
Brief Title
ABI-007 and Bevacizumab in Treating Women With Recurrent or Metastatic Breast Cancer
Official Title
Phase II Trial of Abraxane Administered on a Weekly Schedule in Combination With Bevacizumab in Metastatic Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Premiere Oncology
4. Oversight
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
recurrent breast cancer, stage IV breast cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
bevacizumab
Intervention Type
Drug
Intervention Name(s)
paclitaxel albumin-stabilized nanoparticle formulation
Primary Outcome Measure Information:
Title
Progression-free survival as measured by RECIST criteria at 1 and 2 years
Secondary Outcome Measure Information:
Title
Response rate measured every 3 courses during treatment
Title
Overall survival
Title
Time to progression
Title
Disease-free survival
Title
Toxicity
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linnea Chap, MD
Organizational Affiliation
Premiere Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Premiere Oncology
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
12. IPD Sharing Statement
Learn more about this trial
ABI-007 and Bevacizumab in Treating Women With Recurrent or Metastatic Breast Cancer
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