Analysis of Surgery in Patients Presenting With Stage IV Breast Cancer

Memorial Sloan Kettering Cancer Center100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Breast Cancer

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (20)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of California San Francisco

San Francisco, California, United States

Georgetown University

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

Washington Cancer Institute at Washington

Washington D.C., 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

...and 10 more locations

Outcomes

Primary Outcomes

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 Outcomes

Determine the incidence of uncontrolled local disease in patients who do/do not undergo surgery.

Time frame: 2 years

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

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

Time frame: 2 years