Clinical trial NCT00941759: Analysis of Surgery in Patients Presenting With Stage IV Breast Cancer
Official title: A Prospective Analysis of Surgery in Patients Presenting With Stage IV Breast Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Keywords: Breast
Blood and tissue collection
Epidemiologic
Questionnaire
TBCRC (Translational Breast Cancer Research Consortium)
09-056
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: University of Chicago
name: Dana-Farber Cancer Institute
name: Georgetown University
name: Johns Hopkins University
name: M.D. Anderson Cancer Center
name: University of Alabama at Birmingham
name: University of California, San Francisco
name: University of North Carolina
name: Duke University
name: Vanderbilt-Ingram Cancer Center
name: Indiana University Melvin and Bren Simon Cancer Center
name: Mayo Clinic
name: University of Pittsburgh Medical Center
name: University of Michigan
First posted: 2009-07-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 2 years
Secondary outcomes:
measure: Determine the incidence of uncontrolled local disease in patients who do/do not undergo surgery.
timeFrame: 2 years
measure: Correlate molecular characteristics of the primary tumor with conventional prognostic factors and survival in patients presenting with stage IV breast cancer.
timeFrame: 2 years
measure: Perform correlative molecular studies of circulating tumor cells, primary and metastatic tumor samples in stage IV breast cancer.
timeFrame: 2 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Washington
country: United States
facility: Washington Cancer Institute at Washington
state: District of Columbia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: The Indiana University Simon Cancer Center
state: Indiana
city: Baltimore
country: United States
facility: John Hopkins Medical Center
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Rockville Centre
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina School of Medicine
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Houston
country: United States
facility: Md Anderson Cancer Center
state: Texas
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Monica Morrow, MD
role: PRINCIPAL_INVESTIGATOR
References: