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An Observational Study in Patients With HER2 Positive Metastatic Breast Cancer (SystHERs Registry)

12. juli 2018 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Brystkræft

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1007

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Alabama
  - Birmingham, Alabama, Forenede Stater, 35205
    - St. Vincent'S Hospital; Birmingham Hematology Oncology Associates, Llc
  - Mobile, Alabama, Forenede Stater, 36604
    - University of South Alabama; Mitchell Cancer Institute
- Arizona
  - Sedona, Arizona, Forenede Stater, 86336
    - Arizona Oncology Associates, PC - NAHOA
  - Tucson, Arizona, Forenede Stater, 85704
    - Arizona Oncology
- Arkansas
  - Hot Springs, Arkansas, Forenede Stater, 71913
    - Genesis Cancer Center
  - Jonesboro, Arkansas, Forenede Stater, 72401
    - NEA Baptist Clinic
  - Little Rock, Arkansas, Forenede Stater, 72205
    - Hematology Oncology Services of Arkansas
  - Rogers, Arkansas, Forenede Stater, 72758
    - Highlands Oncology Group
- California
  - Burbank, California, Forenede Stater, 91505
    - East Valley Hem/Onc Med Group; Metropolitan Hem Onc.
  - Campbell, California, Forenede Stater, 95008
    - South Bay Oncology Hematology Partners
  - Encinitas, California, Forenede Stater, 92008
    - California Cancer Associates for Research & Excellence, Inc.
  - Fountain Valley, California, Forenede Stater, 92708-7510
    - ROBERT A. MOSS, M.D., F.A.C.P., Inc
  - Fresno, California, Forenede Stater, 93720
    - Cancer Care Associates
  - Fresno, California, Forenede Stater, 93710
    - California Oncology of the Central Valley
  - Fullerton, California, Forenede Stater, 92835
    - St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr
  - Los Angeles, California, Forenede Stater, 90033
    - University of Southern California
  - Los Angeles, California, Forenede Stater, 90095
    - UCLA School of Medicine
  - Palm Springs, California, Forenede Stater, 92262
    - Comprehensive Cancer Care
  - San Francisco, California, Forenede Stater, 94115
    - Univ of Calif, San Francisco; Breast Cancer Center
  - San Luis Obispo, California, Forenede Stater, 93401
    - Coastal Integrative Cancer Care
  - Santa Maria, California, Forenede Stater, 93454
    - Central Coast Medical Oncology
  - Santa Rosa, California, Forenede Stater, 95403
    - Sutter Pacific Medical Foundation
- Colorado
  - Denver, Colorado, Forenede Stater, 80220
    - Rocky Mountain Cancer Center - Denver
  - Denver, Colorado, Forenede Stater, 80218
    - Kaiser Permanente of Colorado
  - Littleton, Colorado, Forenede Stater, 80122
    - Mile High Oncology
- Connecticut
  - Middletown, Connecticut, Forenede Stater, 06457
    - Connecticut Oncology Group
  - New Haven, Connecticut, Forenede Stater, 06520
    - Yale Cancer Center
  - Stamford, Connecticut, Forenede Stater, 06902
    - Hematology Oncology P.C.
- District of Columbia
  - Washington, District of Columbia, Forenede Stater, 20010
    - MedStar Washington Hosp Center
- Florida
  - Boca Raton, Florida, Forenede Stater, 33428
    - Lynn Cancer Institute - West
  - Deerfield Beach, Florida, Forenede Stater, 33442
    - University of Miami; Dept Sylvester Cancer Center
  - Fort Myers, Florida, Forenede Stater, 33901-8101
    - Florida Cancer Specialists - Fort Myers (New Hampshire Ct)
  - Hollywood, Florida, Forenede Stater, 33021
    - Memorial Cancer Institute
  - Jacksonville, Florida, Forenede Stater, 32207
    - Baptist - MD Anderson Cancer Center
  - Jacksonville, Florida, Forenede Stater, 32256
    - Florida Oncology Associates
  - Lakeland, Florida, Forenede Stater, 33804-1057
    - Lakeland Regional Cancer Center
  - Orlando, Florida, Forenede Stater, 32806
    - MD Anderson Cancer Center Orlando
  - Plantation, Florida, Forenede Stater, 33324
    - Florida Cancer Research Institute
  - Saint Petersburg, Florida, Forenede Stater, 33705
    - Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)
  - Titusville, Florida, Forenede Stater, 32795
    - Space Coast Medical Associates
- Georgia
  - Atlanta, Georgia, Forenede Stater, 30318
    - Peachtree Hematology & Oncology Consultants, Pc
  - Marietta, Georgia, Forenede Stater, 30060
    - Northwest Georgia Oncology Centers PC - Marietta
  - Savannah, Georgia, Forenede Stater, 31405
    - Summit Cancer Care PC
- Idaho
  - Post Falls, Idaho, Forenede Stater, 83854
    - Kootenai Cancer Center
- Illinois
  - Alton, Illinois, Forenede Stater, 62002
    - Alton Memorial Hospital; Outpatient Clinic and Infusion Center
  - Chicago, Illinois, Forenede Stater, 60612
    - Rush University Medical Center
  - Normal, Illinois, Forenede Stater, 61761
    - Mid-Illinois Hematology
  - Park Ridge, Illinois, Forenede Stater, 60068
    - Oncology Specialists, S.C.
  - Skokie, Illinois, Forenede Stater, 60076
    - Orchard Healthcare Research Inc.
  - Urbana, Illinois, Forenede Stater, 61801
    - Carle Cancer Center
- Indiana
  - Evansville, Indiana, Forenede Stater, 47714
    - Oncology Hematology Assoc
- Iowa
  - Ames, Iowa, Forenede Stater, 50010
    - McFarland Clinic
  - Iowa City, Iowa, Forenede Stater, 52242
    - University of Iowa
  - Mason City, Iowa, Forenede Stater, 50401
    - Mercy Medical Ctr-North Iowa ; Mercy Cancer Center
- Kansas
  - Wichita, Kansas, Forenede Stater, 67214-3728
    - Cancer Center of Kansas
- Kentucky
  - Louisville, Kentucky, Forenede Stater, 40207
    - Baptist Hospital East
  - Louisville, Kentucky, Forenede Stater, 40202
    - James Graham Brown Cancer Center, University of Louisville
- Louisiana
  - Baton Rouge, Louisiana, Forenede Stater, 70809
    - Medical Oncology LLC
  - Baton Rouge, Louisiana, Forenede Stater, 70809
    - Mary Bird Perkins Cancer Ctr
  - Lafayette, Louisiana, Forenede Stater, 70503-2616
    - Lafayette General Medical Center
- Maine
  - Portland, Maine, Forenede Stater, 04102
    - Mercy Oncology / Hematology Center; Oncology
- Maryland
  - Cumberland, Maryland, Forenede Stater, 21502
    - Western Maryland Health Sys
  - Rockville, Maryland, Forenede Stater, 20850
    - Associates in Oncology/Hematology P.C.
  - Silver Spring, Maryland, Forenede Stater, 20902
    - Capitol Hematology & Oncology
  - Towson, Maryland, Forenede Stater, 21204
    - St. Joseph Medical Center
  - Westminster, Maryland, Forenede Stater, 21157
    - Carroll County Cancer Center
- Massachusetts
  - Pittsfield, Massachusetts, Forenede Stater, 01201
    - Berkshire Hematology, Oncology Pc
- Michigan
  - Grand Rapids, Michigan, Forenede Stater, 49503
    - Cancer & Hematology Centers of Western Michigan
  - Kalamazoo, Michigan, Forenede Stater, 49007
    - West Michigan Cancer Center
- Minnesota
  - Edina, Minnesota, Forenede Stater, 55435
    - Southdale Cancer Clinic U of M Medical Center, Fairview- Edina
  - Minneapolis, Minnesota, Forenede Stater, 55407
    - Minnesota Oncology Hematology, PA
  - Saint Louis Park, Minnesota, Forenede Stater, 55416
    - Park Nicollet Clinic Cancer Center
- Mississippi
  - Jackson, Mississippi, Forenede Stater, 39202
    - Jackson Oncology Associates, PLLC
- Missouri
  - Jefferson City, Missouri, Forenede Stater, 65109
    - Jefferson City Medical Group
  - Kansas City, Missouri, Forenede Stater, 64132
    - Research Medical Center; Pharmacy
  - Saint Louis, Missouri, Forenede Stater, 63141
    - St. John'S Mercy Medical Center; David C. Pratt Cancer Center
  - Saint Louis, Missouri, Forenede Stater, 63136
    - Christian Hospital; Outpatient Cancer and Infusion Center
- Montana
  - Billings, Montana, Forenede Stater, 59101
    - Billings Clinic Research Center
  - Missoula, Montana, Forenede Stater, 59802
    - Montana Cancer Specialists
- Nebraska
  - Lincoln, Nebraska, Forenede Stater, 68510
    - Southeast Nebraska Cancer Center;; Southeast Nebraska Hematology and Oncology
  - Omaha, Nebraska, Forenede Stater, 68106
    - Cancer Alliance of Nebraska
- Nevada
  - Las Vegas, Nevada, Forenede Stater, 89128
    - Comprehensive Cancer Centers of Nevada
- New Hampshire
  - Lebanon, New Hampshire, Forenede Stater, 03756
    - Dartmouth Hitchcock Medical Center; Gastroenterology Section
  - Portsmouth, New Hampshire, Forenede Stater, 03801
    - Portsmouth Regional Hospital; Hem/Onc Clinic
- New Jersey
  - Berkeley Heights, New Jersey, Forenede Stater, 07922
    - Summit Medical Group
  - Denville, New Jersey, Forenede Stater, 07834
    - Onc & Hematology Specialists
  - Hackensack, New Jersey, Forenede Stater, 07601
    - Hackensack University Medical Center
  - Morristown, New Jersey, Forenede Stater, 07960
    - Hematology Oncology Associates; Carol G. Simon Ctr
  - Paramus, New Jersey, Forenede Stater, 07652
    - Luckow Pavillion, Valley Hosp; Office of Clinical Trials
- New York
  - Cooperstown, New York, Forenede Stater, 13326
    - The Mary Imogene Bassett Hospi
  - East Setauket, New York, Forenede Stater, 11733
    - North Shore Hem Onc Associates
  - Jamaica, New York, Forenede Stater, 11432
    - Queens Hospital Center
  - New York, New York, Forenede Stater, 10032
    - Herbert Irving Comprehensive Cancer Center; Herbert Irving Pavillion
  - New York, New York, Forenede Stater, 10011
    - Beth Israel Comprehensive Cancer Center Pharmacy
- North Carolina
  - Asheville, North Carolina, Forenede Stater, 28806
    - Hope A Women's Cancer Center
  - Gastonia, North Carolina, Forenede Stater, 28054
    - Gaston Hematology/Oncology
  - Greensboro, North Carolina, Forenede Stater, 27403
    - Cone Health Cancer Center
  - Lumberton, North Carolina, Forenede Stater, 28358
    - Southeastern Regional Medical Center
  - Pinehurst, North Carolina, Forenede Stater, 28374
    - First Health of the Carolinas
- Ohio
  - Cleveland, Ohio, Forenede Stater, 44109
    - Metro Health Medical Center
  - Columbus, Ohio, Forenede Stater, 43219
    - Mid Ohio Onc Hematology Inc
  - Middletown, Ohio, Forenede Stater, 45042
    - Signal Point Clinical; Research Center, LLC
  - Sylvania, Ohio, Forenede Stater, 43560
    - Flower Memorial Hospital
- Oklahoma
  - Oklahoma City, Oklahoma, Forenede Stater, 73120
    - Mercy Clinic Oklahoma Communties, Inc
  - Tulsa, Oklahoma, Forenede Stater, 74104
    - Cancer Care Assoc-15th St
- Oregon
  - Portland, Oregon, Forenede Stater, 97231
    - Providence Cancer Center
- Pennsylvania
  - Dunmore, Pennsylvania, Forenede Stater, 18512
    - Hematology & Oncology Assoc; North Eastern Pennsylvania
  - Lancaster, Pennsylvania, Forenede Stater, 17605
    - Lancaster Cancer Center, Ltd.
  - Philadelphia, Pennsylvania, Forenede Stater, 19140
    - Temple University Hospital
  - Pittsburgh, Pennsylvania, Forenede Stater, 15213
    - Univ of Pittsburgh Sch of Med; Magee-Womens Hospital
  - Pittsburgh, Pennsylvania, Forenede Stater, 15212
    - Allegheny General Hospital; Transplantation Services
  - Sayre, Pennsylvania, Forenede Stater, 18840
    - Guthrie Clinic
- South Carolina
  - Charleston, South Carolina, Forenede Stater, 29414
    - Charleston Hematology Oncology
  - Charleston, South Carolina, Forenede Stater, 29425
    - Medical Univ Of South Carolina
  - Columbia, South Carolina, Forenede Stater, 29210
    - South Carolina Oncology Associates - SCRI
- Tennessee
  - Chattanooga, Tennessee, Forenede Stater, 37404
    - Chattanooga Oncology and Hematology Associates, PC
  - Kingsport, Tennessee, Forenede Stater, 37660
    - Kingsport Hematology Oncology Associates
  - Knoxville, Tennessee, Forenede Stater, 37909
    - Center for Biomedical Research LLC
  - Nashville, Tennessee, Forenede Stater, 37203
    - Sarah Cannon Research Inst.
  - Nashville, Tennessee, Forenede Stater, 37203
    - Boston Baskin Cancer Foundation
- Texas
  - Abilene, Texas, Forenede Stater, 79601-2301
    - Hendrick Cancer Center
  - Bedford, Texas, Forenede Stater, 76022
    - Texas Oncology
  - Bryan, Texas, Forenede Stater, 77802
    - St. Joseph Regional Cancer Ct
  - Dallas, Texas, Forenede Stater, 75246
    - Texas Oncology-Baylor Sammons Cancer Center
  - El Paso, Texas, Forenede Stater, 79915
    - Texas Oncology- El Paso Cancer Treatment Center Gateway
  - Fort Worth, Texas, Forenede Stater, 76104
    - Texas Oncology, P.A. - Fort Worth
  - Houston, Texas, Forenede Stater, 77024
    - Texas Oncology - Houston (Gessner)
  - McAllen, Texas, Forenede Stater, 78503
    - Texas Oncology, P.A. - McAllen; South Texas Cancer Center-McAllen
  - Paris, Texas, Forenede Stater, 75460
    - Texas Oncology - Paris
  - Tyler, Texas, Forenede Stater, 75701
    - Tyler Hematololgy Oncology, PA
  - Waco, Texas, Forenede Stater, 76712
    - Texas Oncology, PA
  - Webster, Texas, Forenede Stater, 77598-4420
    - Texas Oncology, P.A.; Duke Slayton Cancer Center
- Utah
  - Ogden, Utah, Forenede Stater, 84403
    - Northern Utah Associates
  - Salt Lake City, Utah, Forenede Stater, 84112
    - Huntsman Cancer Institute; Oncology
- Virginia
  - Lynchburg, Virginia, Forenede Stater, 24501
    - Lynchburg Hem Onc Clinic Inc
  - Newport News, Virginia, Forenede Stater, 23601
    - Peninsula Cancer Institute
  - Richmond, Virginia, Forenede Stater, 23226
    - Virginia Cancer Institute
  - Winchester, Virginia, Forenede Stater, 22601
    - Shenandoah Oncology Associates
- Washington
  - Seattle, Washington, Forenede Stater, 98101
    - Virginia Mason Medical Center
- West Virginia
  - Morgantown, West Virginia, Forenede Stater, 26056
    - West Virginia University Hospitals Inc
- Wisconsin
  - Madison, Wisconsin, Forenede Stater, 53792
    - University of Wisconsin
  - Milwaukee, Wisconsin, Forenede Stater, 53211
    - Columbia Saint Mary's; Medical Oncology

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Patients with HER2 positive (HER2+) metastatic breast cancer

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte Gruppe / kohorte En gruppe eller undergruppe af deltagere i et observationsstudie, der vurderes for biomedicinske eller sundhedsmæssige resultater.
Kohorte

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Tidsramme
Distribution of patients receiving unique treatment regimen/sequence of treatment regimens Tidsramme: Up to 8 years	Up to 8 years

Sekundære resultatmål

Resultatmål	Tidsramme
Progressionsfri overlevelse (PFS) Tidsramme: Op til 8 år	Op til 8 år
Samlet overlevelse (OS) Tidsramme: Op til 8 år	Op til 8 år
Post-progression survival (PPS) Tidsramme: Up to 8 years	Up to 8 years
Time-to-treatment failure (TTF) Tidsramme: Up to 8 years	Up to 8 years
Response rate (RR) Tidsramme: Up to 8 years	Up to 8 years
Safety: Incidence of adverse events Tidsramme: Up to 8 years	Up to 8 years
Patient-reported outcome assessment (PRO) Tidsramme: Up to 8 years	Up to 8 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Genentech, Inc.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. juni 2012

Primær færdiggørelse (Faktiske)

16. november 2017

Studieafslutning (Faktiske)

16. november 2017

Datoer for studieregistrering

Først indsendt

6. juni 2012

Først indsendt, der opfyldte QC-kriterier

7. juni 2012

Først opslået (Skøn)

8. juni 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juli 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juli 2018

Sidst verificeret

1. juli 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

ML28257

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .