Study of MDX-010 in Stage IV Breast Cancer

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