Analysis of Surgery in Patients Presenting With Stage IV Breast Cancer
NCT ID: NCT00941759
Last Updated: 2025-07-16
Study Results
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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COMPLETED
100 participants
OBSERVATIONAL
2009-07-31
2023-07-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Known or suspected Stage IV disease & an intact primary
Pt will be asked to undergo a research core needle biopsy of the primary tumor. If pts are not agreeable to a research biopsy then the original diagnostic biopsy material will be requested. They will also undergo a diagnostic biopsy of a metastatic site, if not already performed, and a blood draw as appropriate for correlative science studies. Additionally, patients will complete a general medical questions form at the time of enrollment.
No interventions assigned to this group
Unsuspected metastatic disease W/I 3 months of primary b
A blood sample will be collected and patients will complete a general medical questions form at the time of enrollment. Paraffin tissue from the prior surgical procedure will be obtained as Tissue sample. Paraffin tissue from the diagnostic biopsy of a metastatic site will also be obtained. In the event that fresh frozen tissue is available for either site this will also be requested.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Known or suspected Stage IV breast cancer with intact primary tumor
* Known or suspected Stage IV breast cancer with intact primary tumor, having begun systemic therapy within the past 12 months
* Known or suspected Stage IV breast cancer within 3 months of local breast surgery
* Known or suspected Stage IV breast cancer within 3 months of local breast surgery, having begun systemic therapy within the past 12 months
Exclusion Criteria
* Failure of MSKCC or participating site to confirm Stage IV breast cancer diagnosis by biopsy within 30 days of study enrollment
18 Years
FEMALE
No
Sponsors
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University of Chicago
OTHER
Dana-Farber Cancer Institute
OTHER
Georgetown University
OTHER
Johns Hopkins University
OTHER
M.D. Anderson Cancer Center
OTHER
University of Alabama at Birmingham
OTHER
University of California, San Francisco
OTHER
University of North Carolina
OTHER
Duke University
OTHER
Vanderbilt-Ingram Cancer Center
OTHER
Indiana University Melvin and Bren Simon Cancer Center
OTHER
Mayo Clinic
OTHER
University of Pittsburgh Medical Center
OTHER
University of Michigan
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Monica Morrow, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California San Francisco
San Francisco, California, United States
Georgetown University
Washington D.C., District of Columbia, United States
Washington Cancer Institute at Washington
Washington D.C., District of Columbia, United States
University of Chicago
Chicago, Illinois, United States
The Indiana University Simon Cancer Center
Indianapolis, Indiana, United States
John Hopkins Medical Center
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Commack
Commack, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, United States
University of North Carolina School of Medicine
Chapel Hill, North Carolina, United States
Duke University
Durham, North Carolina, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Md Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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09-056
Identifier Type: -
Identifier Source: org_study_id
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