Clinical Study to Assess Entry of Chemotherapeutic Agents Into Brain Metastases in Women With Breast Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed breast carcinoma with ≥ 1 suspected or
known parenchymal brain metastases for which surgical resection or biopsy is
clinically indicated

- Treating oncologist must agree that the patient would derive clinical benefit from
receiving ≥ 1 of the following study agents:

- Capecitabine, cyclophosphamide, doxorubicin hydrochloride, gemcitabine
hydrochloride, lapatinib ditosylate, paclitaxel, trastuzumab (Herceptin®), or
vinorelbine ditartrate

- Hormone receptor status not specified

PATIENT CHARACTERISTICS:

- Menopausal status not specified

- Karnofsky performance status 50-100%

- Life expectancy ≥ 3 months

- Absolute granulocyte count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 10 g/dL

- Creatinine ≤ 1.5 times upper limit of normal (ULN)

- Bilirubin (total) ≤ 1.5 times ULN

- AST ≤ 3 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for three months after
completion of study treatment

- No severe NYHA class III-IV cardiac insufficiency with uncontrolled and/or unstable
cardiac or coronary artery disease

- No history of noncompliance to medical regimens or inability or unwillingness to
return for all scheduled visits

PRIOR CONCURRENT THERAPY:

- No toxicity > grade 2 from prior chemotherapy or radiotherapy remains at the time of
study entry

- At least 60 days since prior bevacizumab

- At least 4 weeks since prior cranial radiotherapy

- At least 3 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas or
mitomycin C)

- At least 2 weeks since prior non-cytotoxic drugs (e.g., small molecule-targeted
drugs)

- No concurrent experimental therapies

- Concurrent hormone therapy and/or trastuzumab (Herceptin®) allowed