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OpenTrials
Completed

NCT Number: NCT00941759

Analysis of Surgery in Patients Presenting With Stage IV Breast Cancer

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

    Time frame: 2 years

Secondary outcomes

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

    Time frame: 2 years

  2. 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

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

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Dana-Farber Cancer Institute
  • Duke University
  • Georgetown University
  • Indiana University
  • 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

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2023
Study completion
2023
First posted
Jul 20, 2009
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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