--- title: Analysis of Surgery in Patients Presenting With Stage IV Breast Cancer nct_id: NCT00941759 overall_status: COMPLETED sponsor: Memorial Sloan Kettering Cancer Center study_type: OBSERVATIONAL primary_condition: Breast Cancer countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00941759.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00941759" ct_last_update_post_date: 2025-07-16 last_seen_at: "2026-05-12T06:12:26.785Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Analysis of Surgery in Patients Presenting With Stage IV Breast Cancer **Official Title:** A Prospective Analysis of Surgery in Patients Presenting With Stage IV Breast Cancer **NCT ID:** [NCT00941759](https://clinicaltrials.gov/study/NCT00941759) ## Key Facts - **Status:** COMPLETED - **Study Type:** OBSERVATIONAL - **Target Enrollment:** 100 - **Lead Sponsor:** Memorial Sloan Kettering Cancer Center - **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 - **Conditions:** Breast Cancer - **Start Date:** 2009-07 - **Completion Date:** 2023-07-10 - **CT.gov Last Update:** 2025-07-16 ## Brief 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. 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. ## Eligibility - **Minimum age:** 18 Years - **Sex:** FEMALE - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **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. ## Primary Outcomes - **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 - **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)_ ## Locations (20) - University of Alabama at Birmingham, Birmingham, Alabama, United States - University of California San Francisco, San Francisco, California, United States - Georgetown University, Washington D.C., District of Columbia, United States - Washington Cancer Institute at Washington, Washington D.C., District of Columbia, United States - University of Chicago, Chicago, Illinois, United States - The Indiana University Simon Cancer Center, Indianapolis, Indiana, United States - John Hopkins Medical Center, Baltimore, Maryland, United States - Dana Farber Cancer Institute, Boston, Massachusetts, United States - University of Michigan Health System, Ann Arbor, Michigan, United States - Mayo Clinic, Rochester, Minnesota, United States - Memorial Sloan Kettering Cancer Center, Basking Ridge, New Jersey, United States - Memorial Sloan Kettering Commack, Commack, New York, United States - Memorial Sloan Kettering Cancer Center, New York, New York, United States - Memorial Sloan Kettering Rockville Centre, Rockville Centre, New York, United States - Memorial Sloan Kettering Nassau, Uniondale, New York, United States - University of North Carolina School of Medicine, Chapel Hill, North Carolina, United States - Duke University, Durham, North Carolina, United States - University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States - Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States - Md Anderson Cancer Center, Houston, Texas, United States ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.university of alabama at birmingham|birmingham|alabama|united states` — added _(2026-05-12)_ - `locations.university of california san francisco|san francisco|california|united states` — added _(2026-05-12)_ - `locations.georgetown university|washington d.c.|district of columbia|united states` — added _(2026-05-12)_ - `locations.washington cancer institute at washington|washington d.c.|district of columbia|united states` — added _(2026-05-12)_ - `locations.university of chicago|chicago|illinois|united states` — added _(2026-05-12)_ - `locations.the indiana university simon cancer center|indianapolis|indiana|united states` — added _(2026-05-12)_ - `locations.john hopkins medical center|baltimore|maryland|united states` — added _(2026-05-12)_ - `locations.dana farber cancer institute|boston|massachusetts|united states` — added _(2026-05-12)_ - `locations.university of michigan health system|ann arbor|michigan|united states` — added _(2026-05-12)_ - `locations.mayo clinic|rochester|minnesota|united states` — added _(2026-05-12)_ - `locations.memorial sloan kettering cancer center|basking ridge|new jersey|united states` — added _(2026-05-12)_ - `locations.memorial sloan kettering commack|commack|new york|united states` — added _(2026-05-12)_ - `locations.memorial sloan kettering cancer center|new york|new york|united states` — added _(2026-05-12)_ - `locations.memorial sloan kettering rockville centre|rockville centre|new york|united states` — added _(2026-05-12)_ - `locations.memorial sloan kettering nassau|uniondale|new york|united states` — added _(2026-05-12)_ - `locations.university of north carolina school of medicine|chapel hill|north carolina|united states` — added _(2026-05-12)_ - `locations.duke university|durham|north carolina|united states` — added _(2026-05-12)_ - `locations.university of pittsburgh medical center|pittsburgh|pennsylvania|united states` — added _(2026-05-12)_ - `locations.vanderbilt-ingram cancer center|nashville|tennessee|united states` — added _(2026-05-12)_ - `locations.md anderson cancer center|houston|texas|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00941759.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00941759* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*