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Sponsored by: |
Baylor Breast Care Center |
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Information provided by: | Baylor Breast Care Center |
ClinicalTrials.gov Identifier: | NCT00570908 |
The purpose of this study is to assess the efficacy and safety of concurrent whole brain radiotherapy (WBRT) and capecitabine followed by combination capecitabine and sunitinib in treating patients with CNS metastases from breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: sunitinib Drug: capecitabine Radiation: WBRT |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2 Trial of Capecitabine Concomitantly With Whole Brain Radiotherapy(WBRT) Followed by Capecitabine and Sunitinib for Central Nervous Suste, (CNS) Metastases in Breast Cancer |
Estimated Enrollment: | 25 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
capecitabine concurrently with WBRT followed by combination capecitabine with sunitinib
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Drug: sunitinib
Sutent
Drug: capecitabine
concurrently
Radiation: WBRT
Whole Brain Radiotherapy 30 Gy in 10 fractions
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Hematological adequacy as indicated by:
Hepatic adequacy as indicated by:
Renal adequacy as indicated by:
Exclusion Criteria:
Vascular disease within 12 months prior to enrollment, defined as one or more of the following:
Contact: Claudette Foreman | 713-798-1999 | caforema@breastcenter.tmc.edu |
United States, Texas | |
Lester and Sue Smith Breast Center at Baylor College of Medicine | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Jenny Chang, MD | Baylor College of Medicine, Breast Center |
Responsible Party: | Baylor College of Medicine, Breast Center ( Yee-Lu Tham, MD ) |
Study ID Numbers: | H-20924, Brain Mets Radiation Study |
Study First Received: | December 7, 2007 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00570908 |
Health Authority: | United States: Food and Drug Administration |
brain metastasis breast cancer metastatic breast cancer |
Capecitabine Skin Diseases Sunitinib |
Neoplasm Metastasis Breast Neoplasms Breast Diseases |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |