Analysis of Surgery in Patients Presenting With Stage IV Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Prospective Analysis of Surgery in Patients Presenting With Stage IV Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00941759
• Other study ID #: 09-056
• Status: Active, not recruiting
• Start date: July 2009
• Est. completion date: July 2024

Study information

• Verified date: July 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	John Hopkins Medical Center	Baltimore	Maryland
United States	Memorial Sloan Kettering Cancer Center	Basking Ridge	New Jersey
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	University of North Carolina School of Medicine	Chapel Hill	North Carolina
United States	University of Chicago	Chicago	Illinois
United States	Memorial Sloan Kettering Commack	Commack	New York
United States	Duke University	Durham	North Carolina
United States	Md Anderson Cancer Center	Houston	Texas
United States	The Indiana University Simon Cancer Center	Indianapolis	Indiana
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Memorial Sloan Kettering Rockville Centre	Rockville Centre	New York
United States	University of California San Francisco	San Francisco	California
United States	Memorial Sloan Kettering Nassau	Uniondale	New York
United States	Georgetown University	Washington	District of Columbia
United States	Washington Cancer Institute at Washington	Washington	District of Columbia

Sponsors (15)

Lead Sponsor

Collaborator

Memorial Sloan Kettering Cancer Center

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Determine the incidence of uncontrolled local disease in patients who do/do not undergo surgery.		2 years
Secondary	Correlate molecular characteristics of the primary tumor with conventional prognostic factors and survival in patients presenting with stage IV breast cancer.		2 years
Secondary	Perform correlative molecular studies of circulating tumor cells, primary and metastatic tumor samples in stage IV breast cancer.		2 years

External Links

•   Memorial Sloan Kettering Cancer Center