NCT00083278

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started May 2003

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 17, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2004

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

April 27, 2012

Status Verified

April 1, 2012

First QC Date

May 17, 2004

Last Update Submit

April 26, 2012

Conditions

Breast CancerAdenocarcinoma

Keywords

Breast CancerStage IV adenocarcinoma of the breast

Interventions

MDX-010DRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Sharp Clinical Oncology Research

San Diego, California, 92123, United States

Location

Wishard Health Services

Indianapolis, Indiana, 46202-2859, United States

Location

Section of Hematology/Oncology, Indiana Cancer Pavilion

Indianapolis, Indiana, 46202-5289, United States

Location

Indiana University, Clarian Health Partners

Indianapolis, Indiana, 46202, United States

Location

Medical Arts Building

Jeffersonville, Indiana, 47130, United States

Location

Kansas City Oncology and Hematology Group

Kansas City, Kansas, 66112, United States

Location

Kansas City Oncology and Hematology Group

Overland Park, Kansas, 66210, United States

Location

LaGrange

La Grange, Kentucky, 40031, United States

Location

Norton Healthcare Inc, Loiusville Oncology Clinical Research Program

Louisville, Kentucky, 40202, United States

Location

Suburban Medical Plaza II

Louisville, Kentucky, 40207, United States

Location

Audubon Oncology/Hematology

Louisville, Kentucky, 40217, United States

Location

Kansas City Oncology and Hematology Group

Kansas City, Missouri, 64131, United States

Location

Kansas City Oncology and Hematology Group

Lee's Summit, Missouri, 64064, United States

Location

Arlington Cancer Center

Arlington, Texas, 76012, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsAdenocarcinoma

Interventions

Ipilimumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 17, 2004

First Posted

May 20, 2004

Study Start

May 1, 2003

Study Completion

February 1, 2006

Last Updated

April 27, 2012

Record last verified: 2012-04

Locations

US(14)