Paclitaxel and Capecitabine in Treating Women With Metastatic Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of paclitaxel and capecitabine in treating women who have metastatic breast cancer.

Detailed Description
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OBJECTIVES: I. Determine the safety, response rate, and efficacy of combination therapy with paclitaxel and capecitabine as first or second line therapy in women with metastatic breast cancer. OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 3 hours on day 1 and capecitabine orally twice daily on days 1-14. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed for survival status every 3 months upon completion of treatment. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Official Title
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An Open-Label Combination Study of Capecitabine and Standard Paclitaxel Therapy as First or Second Line Therapy in Women With Metastatic Breast Carcinoma

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: capecitabine
* Drug: paclitaxel


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic breast cancer Bidimensionally measurable disease Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 to 75 Sex: Female Menopausal status: Not specified Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: ANC at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) Renal: Creatinine less than 1.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Eligible patients may have received prior chemotherapy in metastatic or adjuvant setting with the following exceptions: At least 12 months since prior fluoropyrimidine therapy At least 12 months since prior taxane therapy Only 1 previous chemotherapeutic regimen in the metastatic setting Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: Not specified

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: capecitabine|nan|
|Drug: paclitaxel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV breast cancer, recurrent breast cancer