Analysis of Surgery in Patients Presenting With Stage IV Breast Cancer

NCT00941759 | Completed

• 1 other identifier: 09-056
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 20

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.

Conditions

Breast Cancer

Keywords

Breast; Blood and tissue collection; Epidemiologic; Questionnaire; TBCRC (Translational Breast Cancer Research Consortium); 09-056

Outcome Measures

Primary Outcomes (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.

  2 years

Secondary Outcomes (3)

• 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.

  2 years

• Perform correlative molecular studies of circulating tumor cells, primary and metastatic tumor samples in stage IV breast cancer.

  2 years

Study Arms (2)

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 Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• University of Chicago: collaborator
• Dana-Farber Cancer Institute: collaborator
• Georgetown University: collaborator
• Johns Hopkins University: collaborator
• M.D. Anderson Cancer Center: collaborator
• University of California, San Francisco: collaborator
• University of North Carolina: collaborator
• Duke University: collaborator
• Vanderbilt-Ingram Cancer Center: collaborator
• Indiana University Melvin and Bren Simon Cancer Center: collaborator
• Mayo Clinic: collaborator
• University of Pittsburgh Medical Center: collaborator
• University of Michigan: collaborator
• University of Alabama at Birmingham: collaborator

Study Sites (20)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Georgetown University

Washington D.C., District of Columbia, United States

Location

Washington Cancer Institute at Washington

Washington D.C., District of Columbia, United States

Location

University of Chicago

Chicago, Illinois, United States

Location

The Indiana University Simon Cancer Center

Indianapolis, Indiana, United States

Location

John Hopkins Medical Center

Baltimore, Maryland, 21287, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Memorial Sloan Kettering Cancer Center

Basking Ridge, New Jersey, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Rockville Centre

Rockville Centre, New York, 11570, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

University of North Carolina School of Medicine

Chapel Hill, North Carolina, 27514, United States

Location

Duke University

Durham, North Carolina, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Md Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

Blood and tissue collection

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Monica Morrow, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2009
• First Posted: July 20, 2009
• Study Start: July 1, 2009
• Primary Completion: July 10, 2023
• Study Completion: July 10, 2023
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

US (20)