Capecitabine and Paclitaxel (Albumin-Stabilized Nanoparticle Formulation) in Treating Women Undergoing Surgery for Stage II or Stage III Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Combination Capecitabine (Xeloda) and ABI-007 (Abraxane, Nanoparticle Albumin-Bound Paclitaxel) Chemotherapy as Neoadjuvant Treatment of Locally Advanced, Operable Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: capecitabine
* Drug: paclitaxel albumin-stabilized nanoparticle formulation
* Procedure: neoadjuvant therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: capecitabine|nan|
|Drug: paclitaxel albumin-stabilized nanoparticle formulation|nan|
|Procedure: neoadjuvant therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological complete response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 
| Overall clinical response rate |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inflammatory breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer