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Investigator(s):
Susan Bates, M.D. Principal Investigator Phone: 301-402-5958 sebates@helix.nih.gov	Laleh Amiri-Kordestani, M.D. Associate Investigator Phone: 301-402-5958 amirikordestal@mail.nih.gov
Referral Contact(s):
Christine Bryla, R.N., M.S.N Research Nurse Phone: 301-451-7868 brylacm@mail.nih.gov	Robin Frye, R.N., B.S.N. Research Nurse Phone: 301-402-5958 Fax: 301-496-9781 fryer@mail.nih.gov

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Key Eligibility Criteria:

• Brain metastasis from breast cancer with or without prior whole-brain radiotherapy (WBRT)
• Able to undergo an MRI and FLT-PET
• At least one radiologically-confirmed and measurable metastatic brain lesion (≥ 1.0 cm in the longest diameter) by Gd-MRI of the brain < 14 days prior to first dose (metastatic brain lesions previously treated with stereotactic radiosurgery (SRS) may not be target)
• Neurologically stable: On a stable doses of corticosteroids and anticonvulsants (not EIAEDs, including phenytoin, phenobarbital, carbamazepine, fosphenytoin, primidone, oxcarbazepine) for ≥ 5 days prior to obtaining the baseline Gd-MRI of the brain and ≥ 5 days prior to first dose
• Karnofsky performance status of ≥ 80 percent (ECOG ≤ 1)
• No CNS disease requiring immediate neurosurgical intervention (e.g., resection, shunt placement, etc.), known leptomeningeal disease, or neuropathy ≥ grade 2

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Study Outline:

• Screening physical examination and imaging studies to determine eligibility for the study
• Patients will be placed in one of two groups depending on their type of breast cancer:
• One group will receive GRN1005 IV (through a vein) every 3 weeks (1 cycle)
• The other group will receive GRN1005 IV and trastuzumab IV every 3 weeks (1 cycle)
• All participants will have FLT-PET prior to cycle 1 and 2 of the study
• Cycles will then continue for as long as there is no progressive disease or unacceptable toxicity
• Participants will be monitored with blood samples, physical examinations, and tumor imaging studies through the cycles of treatment

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 9/12/12
Updated: 5/3/12