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

12. juli 2018 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Brystkreft

Studietype

Observasjonsmessig

Registrering (Faktiske)

1007

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
Kohort

Hva måler studien?

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
Progresjonsfri overlevelse (PFS) Tidsramme: Inntil 8 år	Inntil 8 år
Total overlevelse (OS) Tidsramme: Inntil 8 år	Inntil 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Genentech, Inc.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. juni 2012

Primær fullføring (Faktiske)

16. november 2017

Studiet fullført (Faktiske)

16. november 2017

Datoer for studieregistrering

Først innsendt

6. juni 2012

Først innsendt som oppfylte QC-kriteriene

7. juni 2012

Først lagt ut (Anslag)

8. juni 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. juli 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. juli 2018

Sist bekreftet

1. juli 2018

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

ML28257

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .