Analysis of Surgery in Patients Presenting With Stage IV Breast Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborators:
University of Chicago
Dana-Farber Cancer Institute
Georgetown University
Johns Hopkins University
M.D. Anderson Cancer Center
University of Alabama at Birmingham
University of California, San Francisco
University of North Carolina
Duke University
Vanderbilt-Ingram Cancer Center
Indiana University Melvin and Bren Simon Cancer Center
Mayo Clinic
University of Pittsburgh
University of Michigan Health System
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00941759
First received: July 16, 2009
Last updated: December 12, 2012
Last verified: December 2012
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Purpose
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.
| Condition |
|---|
|
Breast Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Prospective Analysis of Surgery in Patients Presenting With Stage IV Breast Cancer |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- 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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Determine the incidence of uncontrolled local disease in patients who do/do not undergo surgery. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Correlate molecular characteristics of the primary tumor with conventional prognostic factors and survival in patients presenting with stage IV breast cancer. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Perform correlative molecular studies of circulating tumor cells, primary and metastatic tumor samples in stage IV breast cancer. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Blood and tissue collection
| Estimated Enrollment: | 100 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
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.
Criteria
Inclusion Criteria:
- Age 18 years or older
- 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:
- Primary breast cancer diagnosis made by FNA only and no pre-treatment core biopsy planned for diagnostic or research purposes.
- Failure of MSKCC or participating site to confirm Stage IV breast cancer diagnosis by biopsy within 30 days of study enrollment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00941759
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| University of California San Francisco | |
| San Francisco, California, United States, 94143 | |
| United States, District of Columbia | |
| Georgetown University | |
| Washington, District of Columbia, United States | |
| Washington Cancer Institute at Washington | |
| Washington, District of Columbia, United States | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States | |
| United States, Indiana | |
| The Indiana University Simon Cancer Center | |
| Indianapolis, Indiana, United States | |
| United States, Maryland | |
| John Hopkins Medical Center | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| University of Michigan Health System | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, New Jersey | |
| Memoral Sloan Kettering Cancer Center | |
| Basking Ridge, New Jersey, United States | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center @ Suffolk | |
| Commack, New York, United States, 11725 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| United States, North Carolina | |
| University of North Carolina School of Medicine | |
| Chapel Hill, North Carolina, United States, 27514 | |
| Duke University | |
| Durham, North Carolina, United States | |
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States | |
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| Md Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
University of Chicago
Dana-Farber Cancer Institute
Georgetown University
Johns Hopkins University
M.D. Anderson Cancer Center
University of Alabama at Birmingham
University of California, San Francisco
University of North Carolina
Duke University
Vanderbilt-Ingram Cancer Center
Indiana University Melvin and Bren Simon Cancer Center
Mayo Clinic
University of Pittsburgh
University of Michigan Health System
Investigators
| Principal Investigator: | Tari King, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00941759 History of Changes |
| Other Study ID Numbers: | 09-056 |
| Study First Received: | July 16, 2009 |
| Last Updated: | December 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
Breast Blood and tissue collection Epidemiologic |
Questionnaire TBCRC (Translational Breast Cancer Research Consortium) 09-056 |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 23, 2013