Study of MDX-010 in Stage IV Breast Cancer

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.

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Key information

Conditions

Breast Cancer Adenocarcinoma Breast Diseases Breast Neoplasms Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Sharp Clinical Oncology Research, San Diego, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MDX-010

Drug

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start: 2003
Study completion: 2006
First posted: May 20, 2004
Registry last updated: Apr 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed