An Observational Study in Patients With HER2 Positive Metastatic Breast Cancer (SystHERs Registry)
2018年7月12日 更新者：Genentech, Inc.
An Observational Cohort Study of Treatment Patterns and Outcomes in Patients With HER2 Positive (HER2+) Metastatic Breast Cancer (SystHERs Registry (Systemic Therapies for HER2+ Metastatic Breast Cancer Study)).
This multi-center, prospective observational study will evaluate the treatment patterns, and the safety in patients with HER2-positive (HER2+) metastatic breast cancer (MBC).
Eligible patients will have an initial metastatic breast cancer diagnosis that has not been previously treated with systemic therapy; patients may be enrolled up to 6 months after the diagnosis.
Data will be collected for up to 8 years.
研究概览
地位
完全的
条件
研究类型
观察性的
注册 (实际的)
1007
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Alabama
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Birmingham、Alabama、美国、35205
- St. Vincent'S Hospital; Birmingham Hematology Oncology Associates, Llc
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Mobile、Alabama、美国、36604
- University of South Alabama; Mitchell Cancer Institute
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Arizona
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Sedona、Arizona、美国、86336
- Arizona Oncology Associates, PC - NAHOA
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Tucson、Arizona、美国、85704
- Arizona Oncology
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Arkansas
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Hot Springs、Arkansas、美国、71913
- Genesis Cancer Center
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Jonesboro、Arkansas、美国、72401
- NEA Baptist Clinic
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Little Rock、Arkansas、美国、72205
- Hematology Oncology Services of Arkansas
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Rogers、Arkansas、美国、72758
- Highlands Oncology Group
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California
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Burbank、California、美国、91505
- East Valley Hem/Onc Med Group; Metropolitan Hem Onc.
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Campbell、California、美国、95008
- South Bay Oncology Hematology Partners
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Encinitas、California、美国、92008
- California Cancer Associates for Research & Excellence, Inc.
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Fountain Valley、California、美国、92708-7510
- ROBERT A. MOSS, M.D., F.A.C.P., Inc
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Fresno、California、美国、93720
- Cancer Care Associates
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Fresno、California、美国、93710
- California Oncology of the Central Valley
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Fullerton、California、美国、92835
- St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr
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Los Angeles、California、美国、90033
- University of Southern California
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Los Angeles、California、美国、90095
- UCLA School of Medicine
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Palm Springs、California、美国、92262
- Comprehensive Cancer Care
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San Francisco、California、美国、94115
- Univ of Calif, San Francisco; Breast Cancer Center
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San Luis Obispo、California、美国、93401
- Coastal Integrative Cancer Care
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Santa Maria、California、美国、93454
- Central Coast Medical Oncology
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Santa Rosa、California、美国、95403
- Sutter Pacific Medical Foundation
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Colorado
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Denver、Colorado、美国、80220
- Rocky Mountain Cancer Center - Denver
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Denver、Colorado、美国、80218
- Kaiser Permanente of Colorado
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Littleton、Colorado、美国、80122
- Mile High Oncology
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Connecticut
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Middletown、Connecticut、美国、06457
- Connecticut Oncology Group
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New Haven、Connecticut、美国、06520
- Yale Cancer Center
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Stamford、Connecticut、美国、06902
- Hematology Oncology P.C.
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District of Columbia
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Washington、District of Columbia、美国、20010
- MedStar Washington Hosp Center
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Florida
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Boca Raton、Florida、美国、33428
- Lynn Cancer Institute - West
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Deerfield Beach、Florida、美国、33442
- University of Miami; Dept Sylvester Cancer Center
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Fort Myers、Florida、美国、33901-8101
- Florida Cancer Specialists - Fort Myers (New Hampshire Ct)
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Hollywood、Florida、美国、33021
- Memorial Cancer Institute
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Jacksonville、Florida、美国、32207
- Baptist - MD Anderson Cancer Center
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Jacksonville、Florida、美国、32256
- Florida Oncology Associates
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Lakeland、Florida、美国、33804-1057
- Lakeland Regional Cancer Center
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Orlando、Florida、美国、32806
- MD Anderson Cancer Center Orlando
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Plantation、Florida、美国、33324
- Florida Cancer Research Institute
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Saint Petersburg、Florida、美国、33705
- Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)
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Titusville、Florida、美国、32795
- Space Coast Medical Associates
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Georgia
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Atlanta、Georgia、美国、30318
- Peachtree Hematology & Oncology Consultants, Pc
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Marietta、Georgia、美国、30060
- Northwest Georgia Oncology Centers PC - Marietta
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Savannah、Georgia、美国、31405
- Summit Cancer Care PC
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Idaho
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Post Falls、Idaho、美国、83854
- Kootenai Cancer Center
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Illinois
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Alton、Illinois、美国、62002
- Alton Memorial Hospital; Outpatient Clinic and Infusion Center
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Chicago、Illinois、美国、60612
- Rush University Medical Center
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Normal、Illinois、美国、61761
- Mid-Illinois Hematology
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Park Ridge、Illinois、美国、60068
- Oncology Specialists, S.C.
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Skokie、Illinois、美国、60076
- Orchard Healthcare Research Inc.
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Urbana、Illinois、美国、61801
- Carle Cancer Center
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Indiana
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Evansville、Indiana、美国、47714
- Oncology Hematology Assoc
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Iowa
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Ames、Iowa、美国、50010
- McFarland Clinic
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Iowa City、Iowa、美国、52242
- University of Iowa
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Mason City、Iowa、美国、50401
- Mercy Medical Ctr-North Iowa ; Mercy Cancer Center
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Kansas
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Wichita、Kansas、美国、67214-3728
- Cancer Center of Kansas
-
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Kentucky
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Louisville、Kentucky、美国、40207
- Baptist Hospital East
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Louisville、Kentucky、美国、40202
- James Graham Brown Cancer Center, University of Louisville
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Louisiana
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Baton Rouge、Louisiana、美国、70809
- Medical Oncology LLC
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Baton Rouge、Louisiana、美国、70809
- Mary Bird Perkins Cancer Ctr
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Lafayette、Louisiana、美国、70503-2616
- Lafayette General Medical Center
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Maine
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Portland、Maine、美国、04102
- Mercy Oncology / Hematology Center; Oncology
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Maryland
-
Cumberland、Maryland、美国、21502
- Western Maryland Health Sys
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Rockville、Maryland、美国、20850
- Associates in Oncology/Hematology P.C.
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Silver Spring、Maryland、美国、20902
- Capitol Hematology & Oncology
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Towson、Maryland、美国、21204
- St. Joseph Medical Center
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Westminster、Maryland、美国、21157
- Carroll County Cancer Center
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Massachusetts
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Pittsfield、Massachusetts、美国、01201
- Berkshire Hematology, Oncology Pc
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Michigan
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Grand Rapids、Michigan、美国、49503
- Cancer & Hematology Centers of Western Michigan
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Kalamazoo、Michigan、美国、49007
- West Michigan Cancer Center
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Minnesota
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Edina、Minnesota、美国、55435
- Southdale Cancer Clinic U of M Medical Center, Fairview- Edina
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Minneapolis、Minnesota、美国、55407
- Minnesota Oncology Hematology, PA
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Saint Louis Park、Minnesota、美国、55416
- Park Nicollet Clinic Cancer Center
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Mississippi
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Jackson、Mississippi、美国、39202
- Jackson Oncology Associates, PLLC
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Missouri
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Jefferson City、Missouri、美国、65109
- Jefferson City Medical Group
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Kansas City、Missouri、美国、64132
- Research Medical Center; Pharmacy
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Saint Louis、Missouri、美国、63141
- St. John'S Mercy Medical Center; David C. Pratt Cancer Center
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Saint Louis、Missouri、美国、63136
- Christian Hospital; Outpatient Cancer and Infusion Center
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Montana
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Billings、Montana、美国、59101
- Billings Clinic Research Center
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Missoula、Montana、美国、59802
- Montana Cancer Specialists
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Nebraska
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Lincoln、Nebraska、美国、68510
- Southeast Nebraska Cancer Center;; Southeast Nebraska Hematology and Oncology
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Omaha、Nebraska、美国、68106
- Cancer Alliance of Nebraska
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Nevada
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Las Vegas、Nevada、美国、89128
- Comprehensive Cancer Centers of Nevada
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New Hampshire
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Lebanon、New Hampshire、美国、03756
- Dartmouth Hitchcock Medical Center; Gastroenterology Section
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Portsmouth、New Hampshire、美国、03801
- Portsmouth Regional Hospital; Hem/Onc Clinic
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New Jersey
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Berkeley Heights、New Jersey、美国、07922
- Summit Medical Group
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Denville、New Jersey、美国、07834
- Onc & Hematology Specialists
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Hackensack、New Jersey、美国、07601
- Hackensack University Medical Center
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Morristown、New Jersey、美国、07960
- Hematology Oncology Associates; Carol G. Simon Ctr
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Paramus、New Jersey、美国、07652
- Luckow Pavillion, Valley Hosp; Office of Clinical Trials
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New York
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Cooperstown、New York、美国、13326
- The Mary Imogene Bassett Hospi
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East Setauket、New York、美国、11733
- North Shore Hem Onc Associates
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Jamaica、New York、美国、11432
- Queens Hospital Center
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New York、New York、美国、10032
- Herbert Irving Comprehensive Cancer Center; Herbert Irving Pavillion
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New York、New York、美国、10011
- Beth Israel Comprehensive Cancer Center Pharmacy
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North Carolina
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Asheville、North Carolina、美国、28806
- Hope A Women's Cancer Center
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Gastonia、North Carolina、美国、28054
- Gaston Hematology/Oncology
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Greensboro、North Carolina、美国、27403
- Cone Health Cancer Center
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Lumberton、North Carolina、美国、28358
- Southeastern Regional Medical Center
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Pinehurst、North Carolina、美国、28374
- First Health of the Carolinas
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Ohio
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Cleveland、Ohio、美国、44109
- Metro Health Medical Center
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Columbus、Ohio、美国、43219
- Mid Ohio Onc Hematology Inc
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Middletown、Ohio、美国、45042
- Signal Point Clinical; Research Center, LLC
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Sylvania、Ohio、美国、43560
- Flower Memorial Hospital
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Oklahoma
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Oklahoma City、Oklahoma、美国、73120
- Mercy Clinic Oklahoma Communties, Inc
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Tulsa、Oklahoma、美国、74104
- Cancer Care Assoc-15th St
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Oregon
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Portland、Oregon、美国、97231
- Providence Cancer Center
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Pennsylvania
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Dunmore、Pennsylvania、美国、18512
- Hematology & Oncology Assoc; North Eastern Pennsylvania
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Lancaster、Pennsylvania、美国、17605
- Lancaster Cancer Center, Ltd.
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Philadelphia、Pennsylvania、美国、19140
- Temple University Hospital
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Pittsburgh、Pennsylvania、美国、15213
- Univ of Pittsburgh Sch of Med; Magee-Womens Hospital
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Pittsburgh、Pennsylvania、美国、15212
- Allegheny General Hospital; Transplantation Services
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Sayre、Pennsylvania、美国、18840
- Guthrie Clinic
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South Carolina
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Charleston、South Carolina、美国、29414
- Charleston Hematology Oncology
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Charleston、South Carolina、美国、29425
- Medical Univ Of South Carolina
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Columbia、South Carolina、美国、29210
- South Carolina Oncology Associates - SCRI
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Tennessee
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Chattanooga、Tennessee、美国、37404
- Chattanooga Oncology and Hematology Associates, PC
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Kingsport、Tennessee、美国、37660
- Kingsport Hematology Oncology Associates
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Knoxville、Tennessee、美国、37909
- Center for Biomedical Research LLC
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Nashville、Tennessee、美国、37203
- Sarah Cannon Research Inst.
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Nashville、Tennessee、美国、37203
- Boston Baskin Cancer Foundation
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Texas
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Abilene、Texas、美国、79601-2301
- Hendrick Cancer Center
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Bedford、Texas、美国、76022
- Texas Oncology
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Bryan、Texas、美国、77802
- St. Joseph Regional Cancer Ct
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Dallas、Texas、美国、75246
- Texas Oncology-Baylor Sammons Cancer Center
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El Paso、Texas、美国、79915
- Texas Oncology- El Paso Cancer Treatment Center Gateway
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Fort Worth、Texas、美国、76104
- Texas Oncology, P.A. - Fort Worth
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Houston、Texas、美国、77024
- Texas Oncology - Houston (Gessner)
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McAllen、Texas、美国、78503
- Texas Oncology, P.A. - McAllen; South Texas Cancer Center-McAllen
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Paris、Texas、美国、75460
- Texas Oncology - Paris
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Tyler、Texas、美国、75701
- Tyler Hematololgy Oncology, PA
-
Waco、Texas、美国、76712
- Texas Oncology, PA
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Webster、Texas、美国、77598-4420
- Texas Oncology, P.A.; Duke Slayton Cancer Center
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Utah
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Ogden、Utah、美国、84403
- Northern Utah Associates
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Salt Lake City、Utah、美国、84112
- Huntsman Cancer Institute; Oncology
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Virginia
-
Lynchburg、Virginia、美国、24501
- Lynchburg Hem Onc Clinic Inc
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Newport News、Virginia、美国、23601
- Peninsula Cancer Institute
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Richmond、Virginia、美国、23226
- Virginia Cancer Institute
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Winchester、Virginia、美国、22601
- Shenandoah Oncology Associates
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Washington
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Seattle、Washington、美国、98101
- Virginia Mason Medical Center
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West Virginia
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Morgantown、West Virginia、美国、26056
- West Virginia University Hospitals Inc
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Wisconsin
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Madison、Wisconsin、美国、53792
- University of Wisconsin
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Milwaukee、Wisconsin、美国、53211
- Columbia Saint Mary's; Medical Oncology
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Patients with HER2 positive (HER2+) metastatic breast cancer
描述
Inclusion Criteria:
- Adult patients, >/=18 years of age
- Initial diagnosis of HER2+ MBC, as diagnosed by the treating physician, no more than 6 months prior to study enrollment
- Availability of cancer-specific historical data points in the patient's medical records
Exclusion Criteria:
- Any inability to provide informed consent
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
队列
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Distribution of patients receiving unique treatment regimen/sequence of treatment regimens
大体时间：Up to 8 years
|
Up to 8 years
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
无进展生存期 (PFS)
大体时间：长达 8 年
|
长达 8 年
|
|
总生存期（OS）
大体时间：长达 8 年
|
长达 8 年
|
|
Post-progression survival (PPS)
大体时间：Up to 8 years
|
Up to 8 years
|
|
Time-to-treatment failure (TTF)
大体时间：Up to 8 years
|
Up to 8 years
|
|
Response rate (RR)
大体时间：Up to 8 years
|
Up to 8 years
|
|
Safety: Incidence of adverse events
大体时间：Up to 8 years
|
Up to 8 years
|
|
Patient-reported outcome assessment (PRO)
大体时间：Up to 8 years
|
Up to 8 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Tripathy D, Brufsky A, Cobleigh M, Jahanzeb M, Kaufman PA, Mason G, O'Shaughnessy J, Rugo HS, Swain SM, Yardley DA, Chu L, Li H, Antao V, Hurvitz SA. De Novo Versus Recurrent HER2-Positive Metastatic Breast Cancer: Patient Characteristics, Treatment, and Survival from the SystHERs Registry. Oncologist. 2020 Feb;25(2):e214-e222. doi: 10.1634/theoncologist.2019-0446. Epub 2019 Oct 14.
- Cobleigh M, Yardley DA, Brufsky AM, Rugo HS, Swain SM, Kaufman PA, Tripathy D, Hurvitz SA, O'Shaughnessy J, Mason G, Antao V, Li H, Chu L, Jahanzeb M. Baseline Characteristics, Treatment Patterns, and Outcomes in Patients with HER2-Positive Metastatic Breast Cancer by Hormone Receptor Status from SystHERs. Clin Cancer Res. 2020 Mar 1;26(5):1105-1113. doi: 10.1158/1078-0432.CCR-19-2350. Epub 2019 Nov 26.
- Hurvitz SA, O'Shaughnessy J, Mason G, Yardley DA, Jahanzeb M, Brufsky A, Rugo HS, Swain SM, Kaufman PA, Tripathy D, Chu L, Li H, Antao V, Cobleigh M. Central Nervous System Metastasis in Patients with HER2-Positive Metastatic Breast Cancer: Patient Characteristics, Treatment, and Survival from SystHERs. Clin Cancer Res. 2019 Apr 15;25(8):2433-2441. doi: 10.1158/1078-0432.CCR-18-2366. Epub 2018 Dec 28.
- Tripathy D, Rugo HS, Kaufman PA, Swain S, O'Shaughnessy J, Jahanzeb M, Mason G, Beattie M, Yoo B, Lai C, Masaquel A, Hurvitz S. The SystHERs registry: an observational cohort study of treatment patterns and outcomes in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer. BMC Cancer. 2014 May 2;14:307. doi: 10.1186/1471-2407-14-307.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2012年6月5日
初级完成 (实际的)
2017年11月16日
研究完成 (实际的)
2017年11月16日
研究注册日期
首次提交
2012年6月6日
首先提交符合 QC 标准的
2012年6月7日
首次发布 (估计)
2012年6月8日
研究记录更新
最后更新发布 (实际的)
2018年7月16日
上次提交的符合 QC 标准的更新
2018年7月12日
最后验证
2018年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.