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Brief Title: GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases
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
Study ID: NCT01480583
Brief Summary: 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).
Detailed Description: Please see Brief Summary section.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Ingalls Memorial Hospital, Harvey, Illinois, United States
NCI, Rockville, Maryland, United States
Name: Betty Lawrence
Affiliation: Angiochem Inc
Role: STUDY_DIRECTOR
Name: Nancy Lin, MD
Affiliation: Dana-Farber Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Susan Bates, MD
Affiliation: National Cancer Institute (NCI)
Role: PRINCIPAL_INVESTIGATOR