An observational study in Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 20 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-16.
Sponsored by Memorial Sloan Kettering Cancer Center · Observational
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 100 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
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.
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
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
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Memorial Sloan Kettering Cancer Center