Study of MDX-010 in Stage IV Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00083278
• Other study ID #: MDX010-12
• Secondary ID: CA184-015
• Status: Completed
• Phase: Phase 2
• First received: May 17, 2004
• Last updated: April 26, 2012
• Start date: May 2003
• Est. completion date: February 2006

Study information

• Verified date: April 2012
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• MDX-010

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

External Links

•   ctr.bms.com/ctd/start.do
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm