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Study of MDX-010 in Stage IV Breast Cancer

Primary Purpose

Breast Cancer, Adenocarcinoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MDX-010
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Stage IV adenocarcinoma of the breast

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sharp Clinical Oncology Research
  • Wishard Health Services
  • Section of Hematology/Oncology, Indiana Cancer Pavilion
  • Indiana University, Clarian Health Partners
  • Medical Arts Building
  • Kansas City Oncology and Hematology Group
  • Kansas City Oncology and Hematology Group
  • LaGrange
  • Norton Healthcare Inc, Loiusville Oncology Clinical Research Program
  • Suburban Medical Plaza II
  • Audubon Oncology/Hematology
  • Kansas City Oncology and Hematology Group
  • Kansas City Oncology and Hematology Group
  • Arlington Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 17, 2004
Last Updated
April 26, 2012
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00083278
Brief Title
Study of MDX-010 in Stage IV Breast Cancer
Official Title
A Phase II Study of MDX-010 in Patients With Stage IV Adenocarcinoma of the Breast
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Adenocarcinoma
Keywords
Breast Cancer, Stage IV adenocarcinoma of the breast

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
MDX-010

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Sharp Clinical Oncology Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Wishard Health Services
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-2859
Country
United States
Facility Name
Section of Hematology/Oncology, Indiana Cancer Pavilion
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Facility Name
Indiana University, Clarian Health Partners
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Medical Arts Building
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
Kansas City Oncology and Hematology Group
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66112
Country
United States
Facility Name
Kansas City Oncology and Hematology Group
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
LaGrange
City
LaGrange
State/Province
Kentucky
ZIP/Postal Code
40031
Country
United States
Facility Name
Norton Healthcare Inc, Loiusville Oncology Clinical Research Program
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Suburban Medical Plaza II
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Audubon Oncology/Hematology
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Kansas City Oncology and Hematology Group
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Kansas City Oncology and Hematology Group
City
Lee's Summit
State/Province
Missouri
ZIP/Postal Code
64064
Country
United States
Facility Name
Arlington Cancer Center
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of MDX-010 in Stage IV Breast Cancer

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