Capecitabine Compared With Vinorelbine in Treating Women With Metastatic Breast Cancer
Breast Cancer

About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring stage IV breast cancer
Eligibility Criteria
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
Sites / Locations
- Ziekenhuis Network Antwerpen Middelheim
- Institut Jules Bordet
- Universitair Ziekenhuis Antwerpen
- Algemeen Ziekenhuis Sint-Augustinus
- Institut Bergonie
- Centre Henri Becquerel
- Klinikum Nuernberg - Klinikum Sued
- Institute of Oncology - Ljubljana
- Cancer Research Centre at Weston Park Hospital
- Western General Hospital
- Beatson Oncology Centre
- Western Infirmary