A Phase II Study of MDX-010 in Patients With Stage IV Adenocarcinoma of the Breast
Data Collection
Adenocarcinoma+6
+ Breast Diseases
+ Breast Neoplasms
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.33 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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
Wishard Health Services
Indianapolis, United StatesSection of Hematology/Oncology, Indiana Cancer Pavilion
Indianapolis, United StatesIndiana University, Clarian Health Partners
Indianapolis, United States