Analysis of Surgery in Patients Presenting With Stage IV Breast Cancer

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Breast Cancer

Study Design

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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 2018
Estimated Study Completion Date :	July 2018

Groups and Cohorts

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Group/Cohort
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.

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 :

1. Determine the incidence of uncontrolled local disease in patients who do/do not undergo surgery. [ Time Frame: 2 years ]
2. 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 ]
3. 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

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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, D.C., District of Columbia, United States
Washington Cancer Institute at Washington
Washington, D.C., 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

Investigators

Principal Investigator:	Monica Morrow, MD	Memorial Sloan Kettering Cancer Center

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Memorial Sloan Kettering Cancer Center 

Responsible Party:	Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00941759 History of Changes
Other Study ID Numbers:	09-056
First Posted:	July 20, 2009
Last Update Posted:	September 7, 2017
Last Verified:	September 2017

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