Status:
COMPLETED
Phase II NCT (Neoadjuvant Chemotherapy) w/ Weekly Abraxane in Combination With Carboplatin & Bevacizumab in Breast Cancer
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Collaborating Sponsors:
Celgene Corporation
Genentech, Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the c...
Detailed Description
OBJECTIVES: Primary * To determine the complete pathological response (pCR) in the breast/axillary lymph nodes in women with stage II or III breast cancer treated with neoadjuvant therapy comprising...
Eligibility Criteria
Inclusion
- Inclusion:
- Histologically confirmed breast cancer
- Clinically or radiographically measurable residual tumor after core biopsy
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Age ≥18 yrs
- Absolute neutrophil count ≥ 1,500/mm³
- Hemoglobin ≥ 9 g/dL
- Platelet count ≥ 100,000/ mm³
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Urine protein:creatinine ratio \< 1.0
- AST (aspartate aminotransferase) and ALT ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Bilirubin normal
- Women of childbearing potential must use effective contraception
- Left ventricular ejection fraction (LVEF) normal by echocardiogram or MUGA
- Exclusion:
- No residual tumor after initial biopsy
- Peripheral neuropathy of grade 2 or higher
- HER-2 neu overexpression either by IHC 3+ or FISH+
- No history of any prior treatment of breast cancer.
- No history of unstable angina or myocardial infarction within the past 12 months
- Pregnant or nursing women
- Anticoagulation therapy within the last 6 months
- History of gastrointestinal bleeding
- Recent hemoptysis
- No known hepatitis B or HIV seropositivity
- No inadequately controlled hypertension, defined as systolic blood pressure (BP) \> 150 mm Hg and/or diastolic BP \> 100 mm Hg despite antihypertensive medications
- History of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association class II-IV congestive heart failure
- History of stroke or transient ischemic attack at any time
- Significant vascular disease (e.g., aortic aneurysm or aortic dissection)
- No symptomatic peripheral vascular disease
- Evidence of bleeding diathesis or coagulopathy
- Significant traumatic injury within the past 28 days
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- Serious, non-healing wound, ulcer, or bone fracture
- Known hypersensitivity to any component of bevacizumab
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00675259
Start Date
July 1 2008
End Date
March 1 2014
Last Update
July 24 2018
Active Locations (1)
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1
Ohio State University Medical Center
Columbus, Ohio, United States, 43210