Capecitabine Compared With Vinorelbine 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. It is not yet known if capecitabine is more effective than vinorelbine in treating metastatic breast cancer. PURPOSE: Randomized phase II/III trial to compare the effectiveness of capecitabine with that of vinorelbine in treating women who have metastatic breast cancer that has been previously treated with chemotherapy.

Detailed Description
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OBJECTIVES: Phase II Study: Compare the response rate in women with previously treated metastatic breast cancer treated with capecitabine vs vinorelbine. Compare the duration of response in patients treated with these drugs. Phase III Study: Compare overall and progression-free survival in patients treated with these drugs. Compare time to treatment failure in patients treated with these drugs. Compare overall safety of these drugs in these patients. Compare quality of life and clinical benefit response in patients treated with these drugs. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and taxane resistance (refractory vs resistant vs sensitive). Phase II: Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive vinorelbine IV on days 1 and 8. Courses repeat every 21 days. Arm II: Patients receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days. In both arms, treatment continues in the absence of progression or unacceptable toxicity. If sufficient response rate is determined in phase II, the phase III study is initiated. Phase III: Patients are randomized and receive treatment as in phase II. Quality of life is assessed prior to randomization, at weeks 3, 6, 9, 18, 24, and 30, and then every 12 weeks until disease progression. Clinical benefit response is assessed daily while patient is on study. Patients are followed every 6 weeks until disease progression and then every 12 weeks thereafter. PROJECTED ACCRUAL: A total of 72 patients (36 per treatment arm) will be accrued for phase II of this study and a total of 406-452 patients (203-226 per treatment arm) will be accrued for phase III of this study within 18.5 months.

Official Title
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A Randomized Phase II-III Trial Evaluating the Efficacy of Capecitabine and Vinorelbine in Anthracycline and Taxane Pre-Treated Metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: capecitabine
* Drug: vinorelbine tartrate


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed breast cancer Metastatic disease Prior treatment with taxanes in the metastatic, adjuvant, or neoadjuvant setting Taxane-resistant disease allowed regardless of duration of prior therapy NOTE: Resistant disease defined as progression during or within 12 weeks after taxane therapy for metastatic disease or a disease-free interval of less than 12 months after neoadjuvant or adjuvant therapy with a taxane Taxane-sensitive disease allowed if at least 4 prior courses were received NOTE: Sensitive disease defined as progression occurring more than 12 weeks after taxane therapy for metastatic disease or more than 12 months after neoadjuvant or adjuvant therapy with a taxane Prior treatment with anthracyclines for metastatic disease or as adjuvant treatment OR medical contraindication to treatment with anthracyclines At least one unidimensionally measurable lesion (phase II study) 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 Not specified Hematopoietic Absolute 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) Transaminases no greater than 2.5 times ULN (5 times ULN if liver metastases present) Renal Creatinine clearance greater than 50 mL/min Cardiovascular No symptomatic ventricular arrhythmias No clinically significant congestive heart failure No clinical or ECG evidence of myocardial infarction within the past 12 months No significant coronary artery disease Other Not pregnant or nursing Fertile patients must use effective contraception No prior malignancy within the past 5 years except contralateral breast cancer, nonmelanoma skin cancer, and adequately treated carcinoma in situ of the cervix No known or prior sensitivity to fluoropyrimidines, including fluorouracil No pre-existing grade 2 or greater neurotoxicity No known malabsorption or upper gastrointestinal abnormalities that would affect absorption of study drug No psychological, familial, sociological, or geographical condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent biologic therapy Chemotherapy See Disease Characteristics No more than 2 prior chemotherapy lines for metastatic disease No prior capecitabine, vinca alkaloids, or continuous fluorouracil No other concurrent chemotherapy Endocrine therapy Prior hormonal therapy allowed No concurrent hormonal therapy Radiotherapy No concurrent radiotherapy Surgery Not specified Other Bisphosphonate therapy for treatment and prevention of bony metastases allowed if initiated prior to study No other concurrent investigational treatment No concurrent brivudine with capecitabine

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
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: capecitabine|nan|
|Drug: vinorelbine tartrate|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