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A Phase II Study of MDX-010 in Patients With Stage IV Adenocarcinoma of the Breast


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Adenocarcinoma

Thank you

Trial Information

A Phase II Study of MDX-010 in Patients With Stage IV Adenocarcinoma of the Breast


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

MDX010-12

NCT ID:

NCT00083278

Start Date:

May 2003

Completion Date:

February 2006

Related Keywords:

  • Breast Cancer
  • Adenocarcinoma
  • Breast Cancer
  • Stage IV adenocarcinoma of the breast
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Breast Neoplasms

Name

Location

Arlington Cancer CenterArlington, Texas  76012
Kansas City Oncology and Hematology GroupKansas City, Missouri  64111
Sharp Clinical Oncology ResearchSan Diego, California  92123
Indiana University, Clarian Health PartnersIndianapolis, Indiana  46202
Section of Hematology/Oncology, Indiana Cancer PavilionIndianapolis, Indiana  46202-5289
Wishard Health ServicesIndianapolis, Indiana  46202-2859
Medical Arts BuildingJeffersonville, Indiana  47130
Kansas City Oncology and Hematology GroupKansas City, Kansas  66112
LaGrangeLaGrange, Kentucky  40031
Suburban Medical Plaza IILouisville, Kentucky  40207
Audubon Oncology/HematologyLouisville, Kentucky  40217
Norton Healthcare Inc, Loiusville Oncology Clinical Research ProgramLouisville, Kentucky  40202