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| Name | Class |
|---|---|
| University of Chicago | OTHER |
| Dana-Farber Cancer Institute | OTHER |
| Georgetown University | OTHER |
| Johns Hopkins University |
The purpose of this study is to study patients presenting with stage IV breast cancer. Stage IV means that the breast cancer has spread to another part of the body outside the breast. This study is important because in different parts of the country some patients are being offered surgical treatment for the breast tumor and some are not. The doctors do not know if surgery for the breast tumor is helpful in patients with stage IV breast cancer. The doctors will collect information about the patient and their treatment to learn more about how patients and doctors make treatment decisions. The doctor will also collect blood samples and tissue samples for laboratory studies to learn more about tumors that have spread to other parts of the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. | ||
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Measure response to first-line therapy, frequency of surgical referral and the proportion of patients who undergo surgery of the primary tumor in stage IV disease. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the incidence of uncontrolled local disease in patients who do/do not undergo surgery. | 2 years | |
| Correlate molecular characteristics of the primary tumor with conventional prognostic factors and survival in patients presenting with stage IV breast cancer. |
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Inclusion Criteria:
Exclusion Criteria:
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Potential research subjects will be identified by a member of the patient's treatment team, either at the time of consultation with the breast surgeon or breast medical oncologist. Patients will be accrued from each of the 15 participating sites.
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| Name | Affiliation | Role |
|---|---|---|
| Monica Morrow, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University of California San Francisco |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| 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 | OTHER |
| Mayo Clinic | OTHER |
| University of Pittsburgh Medical Center | OTHER |
| University of Michigan | OTHER |
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Blood and tissue collection
| 2 years |
| Perform correlative molecular studies of circulating tumor cells, primary and metastatic tumor samples in stage IV breast cancer. | 2 years |
| San Francisco |
| California |
| 94143 |
| 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 | 21287 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Memorial Sloan Kettering Cancer Center | Basking Ridge | New Jersey | United States |
| Memorial Sloan Kettering Commack | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Rockville Centre | Rockville Centre | New York | 11570 | United States |
| Memorial Sloan Kettering Nassau | Uniondale | New York | 11553 | United States |
| University of North Carolina School of Medicine | Chapel Hill | North Carolina | 27514 | United States |
| Duke University | Durham | North Carolina | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| Md Anderson Cancer Center | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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