Completed

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

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What is being tested

Data Collection

Who is being recruted

Adenocarcinoma+6

+ Breast Diseases

+ Breast Neoplasms

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 2003
See protocol details

Summary

Principal SponsorBristol-Myers Squibb
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2003

Actual date on which the first participant was enrolled.

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.

Official TitleA Phase II Study of MDX-010 in Patients With Stage IV Adenocarcinoma of the Breast 
NCT00083278
Principal SponsorBristol-Myers Squibb
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

33 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenocarcinomaBreast DiseasesBreast NeoplasmsCarcinomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialSkin Diseases

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 14 locations

Suspended

Sharp Clinical Oncology Research

San Diego, United StatesSee the location
Suspended

Wishard Health Services

Indianapolis, United States
Suspended

Section of Hematology/Oncology, Indiana Cancer Pavilion

Indianapolis, United States
Suspended

Indiana University, Clarian Health Partners

Indianapolis, United States
Completed14 Study Centers