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1B-11-6-A Phase II, Multi-center, Open-label Study Evaluating GRN1005 Alone or in Combination with Trastuzumab in Breast Cancer Patients with Brain Metastases

Description

Please see Brief Summary section.

Phase

Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.

Inclusion and Exclusion 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

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

Sites

  • Illinois

    • Ingalls Memorial Hospital, Harvey, Illinois, 60426
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