Inclusion Criteria

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

- Wwarfarin allowed if patient is on a stable dose and has an INR < 3.0