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

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