Study of MDX-010 in Stage IV Breast Cancer

NCT ID: NCT00083278

Last Updated: 2012-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2006-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Adenocarcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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MDX-010

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Sharp Clinical Oncology Research

San Diego, California, United States

Site Status

Wishard Health Services

Indianapolis, Indiana, United States

Site Status

Section of Hematology/Oncology, Indiana Cancer Pavilion

Indianapolis, Indiana, United States

Site Status

Indiana University, Clarian Health Partners

Indianapolis, Indiana, United States

Site Status

Medical Arts Building

Jeffersonville, Indiana, United States

Site Status

Kansas City Oncology and Hematology Group

Kansas City, Kansas, United States

Site Status

Kansas City Oncology and Hematology Group

Overland Park, Kansas, United States

Site Status

LaGrange

La Grange, Kentucky, United States

Site Status

Norton Healthcare Inc, Loiusville Oncology Clinical Research Program

Louisville, Kentucky, United States

Site Status

Suburban Medical Plaza II

Louisville, Kentucky, United States

Site Status

Audubon Oncology/Hematology

Louisville, Kentucky, United States

Site Status

Kansas City Oncology and Hematology Group

Kansas City, Missouri, United States

Site Status

Kansas City Oncology and Hematology Group

Lee's Summit, Missouri, United States

Site Status

Arlington Cancer Center

Arlington, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CA184-015

Identifier Type: OTHER

Identifier Source: secondary_id

MDX010-12

Identifier Type: -

Identifier Source: org_study_id

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