Status:
COMPLETED
Study of MDX-010 in Stage IV Breast Cancer
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Breast Cancer
Adenocarcinoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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, chemot...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00083278
Start Date
May 1 2003
End Date
February 1 2006
Last Update
April 27 2012
Active Locations (14)
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1
Sharp Clinical Oncology Research
San Diego, California, United States, 92123
2
Wishard Health Services
Indianapolis, Indiana, United States, 46202-2859
3
Section of Hematology/Oncology, Indiana Cancer Pavilion
Indianapolis, Indiana, United States, 46202-5289
4
Indiana University, Clarian Health Partners
Indianapolis, Indiana, United States, 46202