GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases

Please see Brief Summary section.

Key Inclusion Criteria:

• Age ≥ 18 years
• Histologically or cytologically-documented breast cancer (HER2 status and ER/PgR status must be known)
• Brain metastasis from breast cancer with or without prior WBRT
• 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 SRS may not be target or non-target lesions)
• Patients must be neurologically stable: On stable doses of corticosteroids and anticonvulsants (not EIAEDs, including phenytoin, phenobarbitol, carbamazepine, fosphenytoin, primidone, oxcarbazepine) for ≥ 5 days prior to obtaining the baseline Gd-MRI of the brain and ≥ 5 days prior to first dose
• KPS ≥ 70%
• Completed WBRT for intra-cranial lesions ≥ 28 days prior to first dose

Key Exclusion Criteria:

• NCI CTCAE v4.0 Grade ≥ 2 neuropathy
• CNS disease requiring immediate neurosurgical intervention (e.g., resection, shunt placement, etc.)
• Known leptomeningeal disease