Breast CancerNCT00941759
Analysis of Surgery in Patients Presenting With Stage IV Breast Cancer
An observational study of Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 20 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 100 participants
- Where
- 20 sitesUnited States
- Study dates
- Jul 2009to 10 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
John Hopkins Medical Center
Baltimore, Maryland, 21287
Memorial Sloan Kettering Cancer Center
Basking Ridge, New Jersey
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
University of North Carolina School of Medicine
Chapel Hill, North Carolina, 27514
University of Chicago
Chicago, Illinois
Memorial Sloan Kettering Commack
Commack, New York, 11725
Duke University
Durham, North Carolina
Md Anderson Cancer Center
Houston, Texas, 77030
The Indiana University Simon Cancer Center
Indianapolis, Indiana
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania
Mayo Clinic
Rochester, Minnesota, 55905
Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York, 11570
University of California San Francisco
San Francisco, California, 94143
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
Georgetown University
Washington D.C., District of Columbia
Washington Cancer Institute at Washington
Washington D.C., District of Columbia
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Keywords
- Breast, Blood and tissue collection, Epidemiologic, Questionnaire, TBCRC (Translational Breast Cancer Research Consortium), 09-056
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (3)
Determine the incidence of uncontrolled local disease in patients who do/do not undergo surgery.
Measured: 2 years
Correlate molecular characteristics of the primary tumor with conventional prognostic factors and survival in patients presenting with stage IV breast cancer.
Measured: 2 years
Perform correlative molecular studies of circulating tumor cells, primary and metastatic tumor samples in stage IV breast cancer.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2009 (estimated)
- Study startJul 2009
- Primary completion10 Jul 2023
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chicago, Dana-Farber Cancer Institute, Georgetown University, Johns Hopkins University, M.D. Anderson Cancer Center, University of Alabama at Birmingham, University of California, San Francisco, University of North Carolina, Duke University, Vanderbilt-Ingram Cancer Center, Indiana University, Mayo Clinic, University of Pittsburgh Medical Center, University of Michigan
- Responsible party
- Sponsor
- Investigators
- Monica Morrow, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941759
- Sponsor's protocol ID
- 09-056
- Status last verified
- Jul 2025
- First submitted
- 16 Jul 2009
- Last updated
- 16 Jul 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Analysis of Surgery in Patients Presenting With Stage IV Breast Cancer
- ClinicalTrials.gov ID
- NCT00941759
- Acronym / sponsor ID
- 09-056
- Conditions
- Breast Cancer
- Keywords
- Breast, Blood and tissue collection, Epidemiologic, Questionnaire, TBCRC (Translational Breast Cancer Research Consortium), 09-056
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- University of Chicago, Dana-Farber Cancer Institute, Georgetown University, Johns Hopkins University, M.D. Anderson Cancer Center, University of Alabama at Birmingham, University of California, San Francisco, University of North Carolina, Duke University, Vanderbilt-Ingram Cancer Center, Indiana University, Mayo Clinic, University of Pittsburgh Medical Center, University of Michigan
- Study start
- Jul 2009
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 20 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica Morrow, MD principal investigator
Memorial Sloan Kettering Cancer Center
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.