Combination Capecitabine (Xeloda) and ABI-007 (Abraxane, Nanoparticle Albumin-Bound Paclitaxel) Chemotherapy as Neoadjuvant Treatment of Locally Advanced, Operable Breast Cancer
18 Years
N/A
Female
Breast Cancer
Trial Information
Combination Capecitabine (Xeloda) and ABI-007 (Abraxane, Nanoparticle Albumin-Bound Paclitaxel) Chemotherapy as Neoadjuvant Treatment of Locally Advanced, Operable Breast Cancer
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
neoadjuvant therapy comprising capecitabine and paclitaxel (albumin-stabilized
nanoparticle formulation) (Abraxane^®).
Secondary
- Evaluate the safety of this regimen in these patients.
- Determine overall clinical response rate in patients treated with this regimen.
OUTLINE: Patients receive up to 4 courses of capecitabine and paclitaxel (nanoparticle
albumin-stabilized formulation) (Abraxane^®) in the absence of disease progression. Patients
then undergo definitive surgical resection of the tumor off study.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pathological complete response rate
Safety Issue:
No
Principal Investigator
Anita Aggarwal, DO, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Washington Hospital Center
Authority:
Unspecified
Study ID:
CDR0000513169
NCT ID:
NCT00397761
Start Date:
July 2006
Completion Date:
Related Keywords:
- Breast Cancer
- inflammatory breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Washington Cancer Institute at Washington Hospital Center | Washington, District of Columbia 20010 |
