Analysis of Surgery in Patients Presenting With Stage IV Breast Cancer

July 11, 2023 updated by: Memorial Sloan Kettering Cancer Center

A Prospective 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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • California
      • San Francisco, California, United States, 94143
        • University of California San Francisco
    • District of Columbia
      • Washington, District of Columbia, United States
        • Georgetown University
      • Washington, District of Columbia, United States
        • Washington Cancer Institute at Washington
    • Illinois
      • Chicago, Illinois, United States
        • University of Chicago
    • Indiana
      • Indianapolis, Indiana, United States
        • The Indiana University Simon Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • John Hopkins Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New Jersey
      • Basking Ridge, New Jersey, United States
        • Memorial Sloan Kettering Cancer Center
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Commack
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • Rockville Centre, New York, United States, 11570
        • Memorial Sloan Kettering Rockville Centre
      • Uniondale, New York, United States, 11553
        • Memorial Sloan Kettering Nassau
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina School of Medicine
      • Durham, North Carolina, United States
        • Duke University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • University of Pittsburgh Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt-Ingram Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Known or suspected Stage IV disease & an intact primary
Pt will be asked to undergo a research core needle biopsy of the primary tumor. If pts are not agreeable to a research biopsy then the original diagnostic biopsy material will be requested. They will also undergo a diagnostic biopsy of a metastatic site, if not already performed, and a blood draw as appropriate for correlative science studies. Additionally, patients will complete a general medical questions form at the time of enrollment.
Unsuspected metastatic disease W/I 3 months of primary b
A blood sample will be collected and patients will complete a general medical questions form at the time of enrollment. Paraffin tissue from the prior surgical procedure will be obtained as Tissue sample. Paraffin tissue from the diagnostic biopsy of a metastatic site will also be obtained. In the event that fresh frozen tissue is available for either site this will also be requested.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine the incidence of uncontrolled local disease in patients who do/do not undergo surgery.
Time Frame: 2 years
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
2 years
Perform correlative molecular studies of circulating tumor cells, primary and metastatic tumor samples in stage IV breast cancer.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

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

Investigators

  • Principal Investigator: Monica Morrow, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

July 16, 2009

First Submitted That Met QC Criteria

July 17, 2009

First Posted (Estimated)

July 20, 2009

Study Record Updates

Last Update Posted (Actual)

July 12, 2023

Last Update Submitted That Met QC Criteria

July 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-056

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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