Analysis of Surgery in Patients Presenting With Stage IV Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00941759
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Perform correlative molecular studies of circulating tumor cells, primary and metastatic tumor samples in stage IV breast cancer. 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 Determine the incidence of uncontrolled local disease in patients who do/do not undergo surgery. 2 years
Trial Locations
- Locations (19)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Georgetown University
🇺🇸Washington, District of Columbia, United States
Washington Cancer Institute at Washington
🇺🇸Washington, District of Columbia, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
The Indiana University Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
John Hopkins Medical Center
🇺🇸Baltimore, Maryland, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Scroll for more (9 remaining)University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States