Breast CancerPhase 2NCT00083278
Study of MDX-010 in Stage IV Breast Cancer
A Phase 2 study testing MDX-010 in people with Breast Cancer and Adenocarcinoma, run by Bristol-Myers Squibb at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Adenocarcinoma
- What is being tested?
- MDX-010
- How many people
- 33 participants
- Where
- 14 sitesUnited States
- Study dates
- May 2003to Feb 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- ECOG performance status of 0-2
- Negative pregnancy test
- Screening lab values must be met
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Arlington Cancer Center
Arlington, Texas, 76012
Wishard Health Services
Indianapolis, Indiana, 46202-2859
Section of Hematology/Oncology, Indiana Cancer Pavilion
Indianapolis, Indiana, 46202-5289
Indiana University, Clarian Health Partners
Indianapolis, Indiana, 46202
Medical Arts Building
Jeffersonville, Indiana, 47130
Kansas City Oncology and Hematology Group
Kansas City, Kansas, 66112
Kansas City Oncology and Hematology Group
Kansas City, Missouri, 64131
LaGrange
La Grange, Kentucky, 40031
Kansas City Oncology and Hematology Group
Lee's Summit, Missouri, 64064
Norton Healthcare Inc, Loiusville Oncology Clinical Research Program
Louisville, Kentucky, 40202
Suburban Medical Plaza II
Louisville, Kentucky, 40207
Audubon Oncology/Hematology
Louisville, Kentucky, 40217
Kansas City Oncology and Hematology Group
Overland Park, Kansas, 66210
Sharp Clinical Oncology Research
San Diego, California, 92123
About this study
Official title: A Phase II Study of MDX-010 in Patients With Stage IV Adenocarcinoma of the Breast
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.
- Conditions
- Breast Cancer, Adenocarcinoma
- Being tested
- MDX-010
- Keywords
- Breast Cancer, Stage IV adenocarcinoma of the breast
- Medical subject headings
- Breast Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDX-010Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2004 (estimated)
- Study startMay 2003
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00083278
- Sponsor's protocol ID
- MDX010-12
- Other IDs
- CA184-015
- Status last verified
- Apr 2012
- First submitted
- 17 May 2004
- Last updated
- 27 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of MDX-010 in Patients With Stage IV Adenocarcinoma of the Breast
- ClinicalTrials.gov ID
- NCT00083278
- Acronym / sponsor ID
- MDX010-12
- Conditions
- Breast Cancer, Adenocarcinoma
- Keywords
- Breast Cancer, Stage IV adenocarcinoma of the breast
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Study completion
- Feb 2006 (actual)
- First posted
- 20 May 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MDX-010 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MDX-010 in people with Breast Cancer and Adenocarcinoma, run by Bristol-Myers Squibb at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2012.