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Sponsored by: |
Medarex |
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Information provided by: | Medarex |
ClinicalTrials.gov Identifier: | NCT00083278 |
This Phase II study is designed to treat patients who have been diagnosed with Stage IV Breast Cancer, which has progressed despite treatment with primary therapies, including hormonal therapy, chemotherapy, and antibody therapy. Thirty-three patients will be treated with the monoclonal antibody MDX-010. The initial antitumor activity profile of MDX-010 will be determined, as well as identification of the induction of any antitumor immunity following the MDX-010 treatment.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer Adenocarcinoma |
Drug: MDX-010 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Efficacy Study |
Official Title: | A Phase II Study of MDX-010 in Patients With Stage IV Adenocarcinoma of the Breast |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Sharp Clinical Oncology Research | |
San Diego, California, United States, 92123 | |
United States, Indiana | |
Medical Arts Building | |
Jeffersonville, Indiana, United States, 47130 | |
Section of Hematology/Oncology, Indiana Cancer Pavilion | |
Indianapolis, Indiana, United States, 46202-5289 | |
Indiana University, Clarian Health Partners | |
Indianapolis, Indiana, United States, 46202 | |
Wishard Health Services | |
Indianapolis, Indiana, United States, 46202-2859 | |
United States, Kansas | |
Kansas City Oncology and Hematology Group | |
Overland Park, Kansas, United States, 66210 | |
Kansas City Oncology and Hematology Group | |
Kansas City, Kansas, United States, 66112 | |
United States, Kentucky | |
Norton Healthcare Inc, Loiusville Oncology Clinical Research Program | |
Louisville, Kentucky, United States, 40202 | |
Suburban Medical Plaza II | |
Louisville, Kentucky, United States, 40207 | |
Audubon Oncology/Hematology | |
Louisville, Kentucky, United States, 40217 | |
LaGrange | |
LaGrange, Kentucky, United States, 40031 | |
United States, Missouri | |
Kansas City Oncology and Hematology Group | |
Kansas City, Missouri, United States, 64131 | |
Kansas City Oncology and Hematology Group | |
Lee's Summit, Missouri, United States, 64064 | |
United States, Texas | |
Arlington Cancer Center | |
Arlington, Texas, United States, 76012 |
Study ID Numbers: | MDX010-12 |
Study First Received: | May 17, 2004 |
Last Updated: | February 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00083278 |
Health Authority: | United States: Food and Drug Administration |
Breast Cancer Stage IV adenocarcinoma of the breast |
Skin Diseases Breast Neoplasms Adenocarcinoma |
Breast Diseases Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |