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| Sponsor: | Bristol-Myers Squibb |
|---|---|
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00083278 |
Purpose
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: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of MDX-010 in Patients With Stage IV Adenocarcinoma of the Breast |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Sharp Clinical Oncology Research | |
| San Diego, California, United States, 92123 | |
| United States, Indiana | |
| Indiana University, Clarian Health Partners | |
| Indianapolis, Indiana, United States, 46202 | |
| Section of Hematology/Oncology, Indiana Cancer Pavilion | |
| Indianapolis, Indiana, United States, 46202-5289 | |
| Wishard Health Services | |
| Indianapolis, Indiana, United States, 46202-2859 | |
| Medical Arts Building | |
| Jeffersonville, Indiana, United States, 47130 | |
| United States, Kansas | |
| Kansas City Oncology and Hematology Group | |
| Kansas City, Kansas, United States, 66112 | |
| Kansas City Oncology and Hematology Group | |
| Overland Park, Kansas, United States, 66210 | |
| United States, Kentucky | |
| LaGrange | |
| LaGrange, Kentucky, United States, 40031 | |
| Suburban Medical Plaza II | |
| Louisville, Kentucky, United States, 40207 | |
| Audubon Oncology/Hematology | |
| Louisville, Kentucky, United States, 40217 | |
| Norton Healthcare Inc, Loiusville Oncology Clinical Research Program | |
| Louisville, Kentucky, United States, 40202 | |
| 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 Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
| Responsible Party: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00083278 History of Changes |
| Other Study ID Numbers: | MDX010-12, CA184-015 |
| Study First Received: | May 17, 2004 |
| Last Updated: | April 23, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Breast Cancer Stage IV adenocarcinoma of the breast |
|
Adenocarcinoma Breast Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Neoplasms by Site Breast Diseases Skin Diseases |