Title Clinical Study to Assess Entry of Chemotherapeutic Agents into Brain Metastases in Women with Breast Cancer
IRB CASE 4107
Hospital Main Campus
Disease Brain, Breast
- To determine the concentration of certain chemotherapeutic drugs in brain metastases from breast cancer
- Age ≥ 18
- Histologically or cytologically documented breast carcinoma with suspected or known parenchymal brain metastases for which surgical resection or biopsy is clinically indicated.
- Karnofsky performance status ≥ 50
- Life expectancy of ≥3 months
- Patients must have the following laboratory parameters:
- Absolute granulocyte count ≥ 1500/mm3
- Platelet count ≥ 100,000 /mm3
- Hemoglobin ≥ 10 gm/dl
- Creatinine ≤ 1.5 x normal
- Bilirubin (total) ≤ 1.5 x normal
- AST ≤ 3 x normal
- Off cytotoxic chemotherapy ≥ 3 weeks (6 weeks for nitrosoureas, mitomycin-C).
- Patients may continue hormone therapy and trastuzumab.
- The patient's treating oncologist must agree that the patient would derive clinical benefit from receiving at least one of the following agents: capecitabine, cyclophosphamide, doxorubicin, gemcitabine, lapatinib, paclitaxel, trastuzumab, or vinorelbine
- Off cranial radiation therapy ≥ 4 weeks
- Women of childbearing potential must have a negative urine or serum pregnancy test at screening.
- All patients of reproductive potential must agree to use an effective method of contraception during the study and three months following termination of treatment.
- Any toxicity > grade 2 felt to be from prior chemotherapy or radiation therapy at time of study entry.
- Patients who have received cytotoxic chemotherapy within 3 weeks (2 weeks for non-cytotoxic drugs [e.g., small molecule targeted drugs] and 6 weeks for nitrosoureas, mitomycin-C)
- Patients who have received bevacizumab in past 60 days
- Patients taking any experimental therapies
- Severe cardiac insufficiency (NYHA III or IV), with uncontrolled and/or unstable cardiac or coronary artery disease.
- Pregnant or lactating females
- A history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits.