Breast Cancer Clinical Trial
Official title:
A Phase II, Multi-center, Open-label Study Evaluating GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases
The purpose of this study is to assess the efficacy, safety, and tolerability of GRN1005 in
patients with brain metastases from breast cancer. For patients with HER2 positive
metastatic breast cancer, GRN1005 will be assessed in combination with Trastuzumab
(Herceptin®) as per standard-of-care practice.
In addition, this study will evaluate the ability of 18F-FLT to determine if the amount of
change in the uptake in the brain metastases from breast cancer after GRN1005 treatment,
correlates with intra-cranial response (for patients enrolled at NCI).
Please see Brief Summary section. ;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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