Status:
WITHDRAWN
Capecitabine and Paclitaxel (Albumin-Stabilized Nanoparticle Formulation) in Treating Women Undergoing Surgery for Stage II or Stage III Breast Cancer
Lead Sponsor:
Medstar Health Research Institute
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-120 years
Phase:
PHASE2
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine and paclitaxel (albumin-stablized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the ...
Detailed Description
OBJECTIVES: Primary * Determine the rate of pathological complete response (i.e., tumor completely gone) in women with previously untreated, unresected, stage II-IIIB breast cancer treated with neoa...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed infiltrating carcinoma of the breast or inflammatory breast cancer
- Stage II-IIIB disease (T1-4, N1-2, M0)
- Previously untreated disease
- Previously unresected disease
- High-risk disease that is not resectable by lumpectomy alone
- Any HER2/neu status (positive, negative, or unknown) allowed
- Hormone receptor status:
- Any estrogen/progesterone status (positive, negative, or unknown) allowed
- PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
- ECOG performance status 0-2
- Life expectancy \> 3 months
- Absolute neutrophil count \> 1,500/mm³
- Platelet count \> 100,000/mm³
- Hemoglobin \> 9.0 g/dL
- Creatinine \< 1.5 mg/dL
- Bilirubin \< 1.5 times upper limit of normal (ULN)
- ALT and AST \< 2.5 times ULN (5 times ULN if due to Gilbert's disease)
- Alkaline phosphatase \< 2.5 times ULN (5 times ULN if due to Gilbert's disease)
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00397761
Start Date
July 1 2006
Last Update
February 17 2021
Active Locations (1)
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1
Washington Cancer Institute at Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010