Analysis of Surgery in Patients Presenting With Stage IV Breast Cancer
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| ClinicalTrials.gov Identifier: NCT00941759 |
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Recruitment Status :
Active, not recruiting
First Posted : July 20, 2009
Last Update Posted : August 2, 2022
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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 Medical Center
University of Michigan
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
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Brief Summary:
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 or disease |
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| Breast Cancer |
| Study Type : | Observational |
| Estimated Enrollment : | 100 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | A Prospective Analysis of Surgery in Patients Presenting With Stage IV Breast Cancer |
| Study Start Date : | July 2009 |
| Estimated Primary Completion Date : | July 2023 |
| Estimated Study Completion Date : | July 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Breast cancer
MedlinePlus related topics:
Breast Cancer
| Group/Cohort |
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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.
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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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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 ]
Secondary Outcome Measures :
- Determine the incidence of uncontrolled local disease in patients who do/do not undergo surgery. [ Time Frame: 2 years ]
- 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 ]
- Perform correlative molecular studies of circulating tumor cells, primary and metastatic tumor samples in stage IV breast cancer. [ Time Frame: 2 years ]
Biospecimen Retention: Samples With DNA
Blood and tissue collection
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00941759
Locations
Show 20 study locations
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 Medical Center
University of Michigan
Investigators
| Principal Investigator: | Monica Morrow, MD | Memorial Sloan Kettering Cancer Center |
Additional Information:
| Responsible Party: | Memorial Sloan Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00941759 |
| Other Study ID Numbers: |
09-056 |
| First Posted: | July 20, 2009 Key Record Dates |
| Last Update Posted: | August 2, 2022 |
| Last Verified: | August 2022 |
Keywords provided by Memorial Sloan Kettering Cancer Center:
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Breast Blood and tissue collection Epidemiologic |
Questionnaire TBCRC (Translational Breast Cancer Research Consortium) 09-056 |
Additional relevant MeSH terms:
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |