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Study of MDX-010 in Stage IV Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00083278
Recruitment Status : Completed
First Posted : May 20, 2004
Last Update Posted : April 27, 2012
Information provided by:
Bristol-Myers Squibb

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Adenocarcinoma Drug: MDX-010 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of MDX-010 in Patients With Stage IV Adenocarcinoma of the Breast
Study Start Date : May 2003
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Ipilimumab

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Provide written informed consent
  • diagnosed with Stage IV adenocarcinoma that has progressed despite previous therapy
  • at least 18 years of age
  • measurable disease defined by RECIST
  • must discontinue any alternative therapy used to treat breast cancer at least 4 weeks prior to enrollment and agree to not use such therapies during the duration of the study (patients may continue to receive tamoxifen, bisphosphate therapy and trastuzumab)
  • prior radiation must be completed at least 4 weeks prior to enrollment
  • ECOG performance status of 0-2
  • Negative pregnancy test
  • Screening lab values must be met

Exclusion Criteria:

  • must be disease free from other cancers for at least 5 years
  • symptomatic or untreated brain metastases
  • active or history of autoimmune disease
  • active HIV, HTLV, HBV or HCV infection
  • concurrent medical condition requiring the use of systemic corticosteroids, must be discontinued at least 4 weeks prior to enrollment
  • prior therapy with anti-CTLA-4 antibody
  • significant organ compromise, uncontrolled heart, liver, lung, or renal disease or other serious illness
  • pregnancy or nursing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00083278

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United States, California
Sharp Clinical Oncology Research
San Diego, California, United States, 92123
United States, Indiana
Wishard Health Services
Indianapolis, Indiana, United States, 46202-2859
Section of Hematology/Oncology, Indiana Cancer Pavilion
Indianapolis, Indiana, United States, 46202-5289
Indiana University, Clarian Health Partners
Indianapolis, Indiana, United States, 46202
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, Kentucky, United States, 40031
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
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
Sponsors and Collaborators
Bristol-Myers Squibb
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
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Responsible Party: Study Director, Bristol-Myers Squibb Identifier: NCT00083278    
Other Study ID Numbers: MDX010-12
CA184-015 ( Other Identifier: BMS )
First Posted: May 20, 2004    Key Record Dates
Last Update Posted: April 27, 2012
Last Verified: April 2012
Keywords provided by Bristol-Myers Squibb:
Breast Cancer
Stage IV adenocarcinoma of the breast
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents, Immunological
Antineoplastic Agents