Analysis of Surgery in Patients Presenting With Stage IV Breast Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Known or suspected Stage IV disease & an intact primary<br>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<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the incidence of uncontrolled local disease in patients who do/do not undergo surgery. |  | 2 years | 
| Correlate molecular characteristics of the primary tumor with conventional prognostic factors and survival in patients presenting with stage IV breast cancer. |  | 2 years | 
| Perform correlative molecular studies of circulating tumor cells, primary and metastatic tumor samples in stage IV breast cancer. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast, Blood and tissue collection, Epidemiologic, Questionnaire, TBCRC (Translational Breast Cancer Research Consortium), 09-056