Capecitabine in Treating Women With Advanced or 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. PURPOSE: Randomized phase II trial to compare the effectiveness of two different doses of capecitabine in treating women who have advanced or metastatic breast cancer.

Detailed Description
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OBJECTIVES: Compare the objective response rate in women with advanced or metastatic breast cancer treated with two dose levels of capecitabine. Compare the duration of response, time to progression, time to treatment failure, survival, incidence of adverse events, and time to onset of the adverse experience in patients treated with this drug. Compare the quality of life of patients treated with this drug. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Karnofsky performance status (70-80% vs 90-100%) and presence of hepatic metastases (yes vs no). Patients are randomized to one of two treatment arms. Arm I: Patients receive lower-dose oral capecitabine twice daily on days 1-14. Arm II: Patients receive higher-dose oral capecitabine twice daily on days 1-14. In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at the end of the third and sixth courses, and at completion of therapy. PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this study within 9 months.

Official Title
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A Pilot Trial Of Two Different Doses Of Capecitabine (XELODA) In Patients With Advanced And/Or Metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: capecitabine


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically and/or cytologically confirmed breast cancer Advanced and/or metastatic disease At least 1 measurable lesion At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan No CNS metastases Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: Karnofsky 70-100% Life expectancy: At least 12 weeks Hematopoietic: Neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) AST/ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present) Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if liver metastases present OR 10 times ULN if bone metastases present) No hepatitis Renal: Creatinine no greater than 1.5 times ULN Creatinine clearance at least 50 mL/min Cardiovascular: No clinically significant cardiac disease No congestive heart failure No symptomatic coronary artery disease No cardiac arrhythmias poorly controlled with medication No myocardial infarction within the past 12 months even if adequately controlled with medication Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No severe pain inadequately controlled by analgesics No prior severe and unexpected reaction to fluoropyrimidine therapy No known hypersensitivity to fluorouracil No impaired physical integrity of the upper gastrointestinal tract No malabsorption syndrome No inability to swallow tablets No history of uncontrolled seizures, central nervous system disorder, or psychiatric disability that would preclude study participation No serious uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 2 but no more than 3 prior chemotherapy regimens At least 1 prior chemotherapy regimen containing paclitaxel and an anthracycline as adjuvant therapy or for advanced and/or metastatic disease Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to target lesions unless there is evidence of new disease within the irradiated field No concurrent radiotherapy Surgery: No prior organ allografts Other: At least 4 weeks since prior investigational drug No concurrent enrollment on other investigational study No other concurrent anticancer agents

Ages Eligible for Study
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Minimum Age: 18 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|

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, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer