Vinflunine and Capecitabine in Treating Patients With Previously Treated Metastatic Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed breast cancer meeting the following criteria:
• * Metastatic disease
• * Previously treated with 1-2 chemotherapy regimens for metastatic disease
• Measurable disease, defined as ≥ 1 measurable lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan
• * No nonmeasurable disease, including any of the following:
• * Bone lesions
• * Leptomeningeal disease
• * Ascites
• * Pleural or pericardial effusion
• * Inflammatory breast disease
• * Lymphangitis cutis/pulmonis
• * Abdominal masses not confirmed and followed by imaging techniques
• * Cystic lesions
• Must have received ≥ 1 prior trastuzumab (Herceptin®)-containing regimen (unless there is a contraindication) if tumor is HER2 positive (3+ by immunohistochemistry or amplified by fluorescent in situ hybridization \[FISH\])
• No CNS metastasis unless controlled by prior surgery and/or radiotherapy
• * "Controlled" is defined as ≥ 2 months of no symptoms or evidence of progression
• Currently enrolled on clinical trial QOL N0392
• Hormone receptor status not specified
• * Hormone-positive tumor must meet at least 1 of the following criteria:
• * Tumor refractory to hormonal therapy
• * Heavy visceral tumor burden that requires chemotherapy for better and faster control of metastatic disease
• * Relapsed disease during adjuvant hormonal therapy and failed first-line chemotherapy
• * Not treated with hormonal therapy because of side effects or adverse events
• PATIENT CHARACTERISTICS:
• Male or female
• Menopausal status not specified
• ECOG performance status 0-2
• Life expectancy ≥ 3 months
• Platelet count ≥ 100,000/mm\^3
• Hemoglobin \> 8.0 g/dL
• WBC ≥ 3,000/mm\^3
• Absolute neutrophil count ≥ 1,500/mm\^3
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase (AP), AST, and ALT must meet 1 of the following criteria:
• * AP normal AND AST and ALT ≤ 5 times ULN
• * AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN
• * AP ≤ 5 times ULN AND AST and ALT normal
• Creatinine clearance ≥ 30 mL/min
• Serum sodium normal
• Not pregnant or nursing
• * No nursing during and for 30 days after completion of study therapy
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 30 days after completion of study therapy
• No history of allergy or hypersensitivity to drug product excipients or to agents chemically similar to vinflunine and/or capecitabine
• No prior unanticipated severe reaction to fluoropyrimidine therapy
• No known hypersensitivity to fluorouracil
• No known dihydropyrimidine dehydrogenase deficiency
• No active, unresolved infection
• No New York Heart Association class III-IV cardiovascular disease, unstable angina, myocardial infarction within the past 6 months, or poorly controlled hypertension
• No preexisting neuropathy ≥ grade 2
• No concurrent serious medical condition that would preclude study treatment
• No other stage III or IV invasive cancer within the past 3 years
• No lack of physical integrity of the upper gastrointestinal tract, clinically significant malabsorption syndrome, or inability to take oral medication
• Ability to complete questionnaires alone or with assistance
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• Prior unlimited hormonal therapy allowed in the neoadjuvant, adjuvant, or metastatic setting
• No major surgery, chemotherapy, or immunologic therapy within the past 4 weeks
• No radiotherapy within the past 4 weeks, except if to a nontarget lesion only
• * Prior radiotherapy to a target lesion is allowed if there has been clear progression of the lesion since radiotherapy was completed
• * If patient received single-dose radiotherapy or palliation to a nontarget lesion only, the patient may immediately proceed to study registration without waiting 4 weeks
• No prior fluoropyrimidines, including capecitabine, or vinca alkaloids (e.g., vinorelbine, vinblastine, vincristine, or vindesine) for metastatic breast cancer
• No prior radiotherapy to \> 30% of bone marrow-containing areas
• No cimetidine, allopurinol, sorivudine, or brivudine within the past 2 weeks
• No ketoconazole, itraconazole, ritonavir, amprenavir, or indinavir within the past 2 weeks
• No concurrent treatment in another clinical trial in which investigational procedures are performed or investigational therapies are administered
• No concurrent trastuzumab (Herceptin®)
• No concurrent hormonal therapy
• No concurrent interleukin-11
• No other concurrent chemotherapeutic agents, biologic agents, or radiotherapy
• No concurrent administration of any of the following:
• * Cimetidine
• * Allopurinol
• * Sorivudine
• * Brivudine
• * Ketoconazole
• * Itraconazole
• * Ritonavir
• * Amprenavir
• * Indinavir
• Warfarin allowed if patient is on a stable dose and has an INR \< 3.0