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Sponsored by: |
Celgene Corporation |
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Information provided by: | Celgene Corporation |
ClinicalTrials.gov Identifier: | NCT00380835 |
The purpose of the study is to evaluate the incidence of cardiac toxicity of amrubicin when administered to patients with metastatic breast cancer.
Condition | Intervention | Phase |
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Metastatic Breast Cancer |
Drug: Amrubicin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Parallel Assignment, Safety Study |
Official Title: | A Phase 2 Trial of Amrubicin With or Without Herceptin in the Treatment of Metastatic Breast Cancer |
Estimated Enrollment: | 66 |
Estimated Study Completion Date: | December 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate organ function including the following:
Exclusion Criteria:
United States, Connecticut | |
New Milford, Connecticut, United States, 06776 | |
Sharon, Connecticut, United States, 06069 | |
Torrington, Connecticut, United States, 06790 | |
United States, Minnesota | |
Minneapolis, Minnesota, United States, 55404 | |
Edina, Minnesota, United States, 55435-2150 | |
Maplewood, Minnesota, United States, 55109 | |
Burnsville, Minnesota, United States, 55337 | |
St. Paul, Minnesota, United States, 55102-2389 | |
Woodbury, Minnesota, United States, 55125 | |
United States, Missouri | |
Columbia, Missouri, United States, 65201 | |
United States, New York | |
Albany, New York, United States, 12208 | |
Latham, New York, United States, 12110-0610 | |
Hudson, New York, United States, 12534 | |
Amsterdam, New York, United States, 12010 | |
Rexford, New York, United States, 12148 | |
Schenectady, New York, United States, 12308 | |
Troy, New York, United States, 12180 | |
United States, North Carolina | |
Asheville, North Carolina, United States, 28803 | |
United States, Texas | |
Dallas, Texas, United States, 75246 | |
El Paso, Texas, United States, 79915 | |
El Paso, Texas, United States, 79902 | |
Midland, Texas, United States, 79701-5946 | |
Odessa, Texas, United States, 79761 | |
Dallas, Texas, United States, 75231-4400 | |
Tyler, Texas, United States, 75702 | |
Dallas, Texas, United States, 75230-2510 | |
Plano, Texas, United States, 75075-7787 | |
Houston, Texas, United States, 77024 |
Study Director: | Richard S Ungerleider, MD | Theradex |
Study ID Numbers: | CNF3140-MBC-001 |
Study First Received: | September 26, 2006 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00380835 |
Health Authority: | United States: Food and Drug Administration |
metastatic breast cancer amrubicin |
Skin Diseases Trastuzumab Breast Neoplasms Amrubicin Breast Diseases |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |