Capecitabine and Paclitaxel (Albumin-Stabilized Nanoparticle Formulation) in Treating Women Undergoing Surgery for Stage II or Stage III Breast Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | July 2006 |
Combination Capecitabine (Xeloda) and ABI-007 (Abraxane, Nanoparticle Albumin-Bound Paclitaxel) Chemotherapy as Neoadjuvant Treatment of Locally Advanced, Operable Breast Cancer
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 cells or by stopping them from dividing. Giving more than
one drug (combination chemotherapy) before surgery may make the tumor smaller and reduce the
amount of normal tissue that needs to be removed.
PURPOSE: This phase II/III trial is studying how well giving capecitabine together with
paclitaxel (albumin-stabilized nanoparticle formulation) works in treating women undergoing
surgery for stage II or stage III breast cancer.
(albumin-stablized nanoparticle formulation, work in different ways to stop the growth of
tumor cells, either by killing the cells or by stopping them from dividing. Giving more than
one drug (combination chemotherapy) before surgery may make the tumor smaller and reduce the
amount of normal tissue that needs to be removed.
PURPOSE: This phase II/III trial is studying how well giving capecitabine together with
paclitaxel (albumin-stabilized nanoparticle formulation) works in treating women undergoing
surgery for stage II or stage III 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.
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.
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
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