Study of MDX-010 in Stage IV Breast Cancer

Completed · Phase 2

Conditions studied: Breast Cancer, Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT00083278

Run by

Bristol-Myers Squibb

People needed

33

Starts

2003-05-01

Expected to finish

2006-02-01

Last updated by the study team

2012-04-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sharp Clinical Oncology Research — San Diego, California, United States
• Wishard Health Services — Indianapolis, Indiana, United States
• Section of Hematology/Oncology, Indiana Cancer Pavilion — Indianapolis, Indiana, United States
• Indiana University, Clarian Health Partners — Indianapolis, Indiana, United States
• Medical Arts Building — Jeffersonville, Indiana, United States
• Kansas City Oncology and Hematology Group — Kansas City, Kansas, United States
• Kansas City Oncology and Hematology Group — Overland Park, Kansas, United States
• LaGrange — La Grange, Kentucky, United States
• Norton Healthcare Inc, Loiusville Oncology Clinical Research Program — Louisville, Kentucky, United States
• Suburban Medical Plaza II — Louisville, Kentucky, United States
• Audubon Oncology/Hematology — Louisville, Kentucky, United States
• Kansas City Oncology and Hematology Group — Kansas City, Missouri, United States
• Kansas City Oncology and Hematology Group — Lee's Summit, Missouri, United States
• Arlington Cancer Center — Arlington, Texas, United States

Full record on ClinicalTrials.gov

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