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Clinical Study to Assess Entry of Chemotherapeutic Agents into Brain Metastases in Women with Breast Cancer
- 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.
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Stay up to date on Cleveland Clinic’s more than 200 active clinical trials for cancer patients. Our free Cancer Clinical Trials app is available for Apple and Android devices.
With this app, you can:
- Search our real time database for trials by disease, phase, physician or hospital location
- Browse information on each trial’s objective, eligibility criteria, stage(s) and more
- Connect to our Cancer Answer Line for more information about a trial or to enroll patients
The app also includes contacts for patient resources, financial services information, support groups and treatment guides.
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Speak with a cancer nurse specialist for appointment assistance and for answers to your questions about cancer locally at 216.444.7923 or toll-free 1.866.223.8100.
Monday through Friday from 8 a.m. – 4:30 p.m. (ET).
Resources for medical professionals
- Outpatient appointment referrals: 216.444.7923 or 866.223.8100
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- Referring Physician Concierge: 216.444.6196 or 216.312.4910.
Search available cancer clinical trials by disease, hospital, phase or number.
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