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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01615068
First received: June 6, 2012
Last updated: April 6, 2017
Last verified: April 2017
  Purpose
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.

Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Cohort Study Of Treatment Patterns And Outcomes In Patients With HER2 Positive (Her2+) Metastatic Breast Cancer (SystHERs Registry (Systematic Therapies for HER2+ Metastatic Breast Cancer Study)).

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Distribution of patients receiving unique treatment regimen/sequence of treatment regimens [ Time Frame: Up to 8 years ]

Secondary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: Up to 8 years ]
  • Overall survival (OS) [ Time Frame: Up to 8 years ]
  • Post-progression survival (PPS) [ Time Frame: Up to 8 years ]
  • Time-to-treatment failure (TTF) [ Time Frame: Up to 8 years ]
  • Response rate (RR) [ Time Frame: Up to 8 years ]
  • Safety: Incidence of adverse events [ Time Frame: Up to 8 years ]
  • Patient-reported outcome assessment (PRO) [ Time Frame: Up to 8 years ]

Biospecimen Retention:   Samples With DNA
Tissue and whole blood samples

Enrollment: 1007
Actual Study Start Date: June 5, 2012
Estimated Study Completion Date: August 28, 2020
Estimated Primary Completion Date: August 28, 2020 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with HER2 positive (HER2+) metastatic breast cancer
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01615068

  Hide Study Locations
Locations
United States, Alabama
St. Vincent'S Hospital; Birmingham Hematology Oncology Associates, Llc
Birmingham, Alabama, United States, 35205
University of South Alabama; Mitchell Cancer Institute
Mobile, Alabama, United States, 36604
United States, Arizona
Arizona Oncology Associates, PC - NAHOA
Sedona, Arizona, United States, 86336
Arizona Oncology
Tucson, Arizona, United States, 85704
United States, Arkansas
Genesis Cancer Center
Hot Springs, Arkansas, United States, 71913
NEA Baptist Clinic
Jonesboro, Arkansas, United States, 72401
Hematology Oncology Services of Arkansas
Little Rock, Arkansas, United States, 72205
Highlands Oncology Group
Rogers, Arkansas, United States, 72758
United States, California
East Valley Hem/Onc Med Group; Metropolitan Hem Onc.
Burbank, California, United States, 91505
South Bay Oncology Hematology Partners
Campbell, California, United States, 95008
California Cancer Associates for Research & Excellence, Inc.
Encinitas, California, United States, 92008
ROBERT A. MOSS, M.D., F.A.C.P., Inc
Fountain Valley, California, United States, 92708-7510
California Oncology of the Central Valley
Fresno, California, United States, 93710
Cancer Care Associates
Fresno, California, United States, 93720
St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr
Fullerton, California, United States, 92835
University of Southern California
Los Angeles, California, United States, 90033
UCLA School of Medicine
Los Angeles, California, United States, 90095
Comprehensive Cancer Care
Palm Springs, California, United States, 92262
Univ of Calif, San Francisco; Breast Cancer Center
San Francisco, California, United States, 94115
Coastal Integrative Cancer Care
San Luis Obispo, California, United States, 93401
Central Coast Medical Oncology
San Luis Obispo, California, United States, 93454
Sutter Pacific Medical Foundation
Santa Rosa, California, United States, 95403
United States, Colorado
Kaiser Permanente Of Colorado
Denver, Colorado, United States, 80205
Rocky Mountain Cancer Center - Denver
Denver, Colorado, United States, 80220
Mile High Oncology
Littleton, Colorado, United States, 80122
United States, Connecticut
Connecticut Oncology Group
Middletown, Connecticut, United States, 06457
Yale Cancer Center
New Haven, Connecticut, United States, 06520
Hematology Oncology P.C.
Stamford, Connecticut, United States, 06902
United States, District of Columbia
MedStar Washington Hosp Center
Washington, District of Columbia, United States, 20010
United States, Florida
Lynn Cancer Institute - West
Boca Raton, Florida, United States, 33428
University of Miami; Dept Sylvester Cancer Center
Deerfield Beach, Florida, United States, 33442
Florida Cancer Specialists - Fort Myers (New Hampshire Ct)
Fort Myers, Florida, United States, 33901-8101
Memorial Cancer Institute
Hollywood, Florida, United States, 33021
Baptist Cancer Institute
Jacksonville, Florida, United States, 32207
Florida Oncology Associates
Jacksonville, Florida, United States, 32256
Lakeland Regional Cancer Center
Lakeland, Florida, United States, 33804-1057
Md Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806
Florida Cancer Research Institute
Plantation, Florida, United States, 33324
Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)
Saint Petersburg, Florida, United States, 33705
Space Coast Medical Associates
Titusville, Florida, United States, 32795
United States, Georgia
Peachtree Hematology & Oncology Consultants, Pc
Atlanta, Georgia, United States, 30318
Northwest Georgia Oncology Centers PC - Marietta
Marietta, Georgia, United States, 30060
Summit Cancer Care PC
Savannah, Georgia, United States, 31405
United States, Idaho
Kootenai Cancer Center
Post Falls, Idaho, United States, 83854
United States, Illinois
Alton Memorial Hospital; Outpatient Clinic and Infusion Center
Alton, Illinois, United States, 62002
Rush University Medical Center
Chicago, Illinois, United States, 60612
Mid-Illinois Hematology
Normal, Illinois, United States, 61761
Oncology Specialists, S.C.
Park Ridge, Illinois, United States, 60068
Orchard Healthcare Research Inc.
Skokie, Illinois, United States, 60076
Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Oncology Hematology Assoc
Evansville, Indiana, United States, 47714
United States, Iowa
McFarland Clinic
Ames, Iowa, United States, 50010
University of Iowa
Iowa City, Iowa, United States, 52242
Mercy Medical Ctr-North Iowa ; Mercy Cancer Center
Mason City, Iowa, United States, 50401
United States, Kansas
Cancer Center of Kansas
Wichita, Kansas, United States, 67214-3728
United States, Kentucky
James Graham Brown Cancer Center, University of Louisville
Louisville, Kentucky, United States, 40202
Baptist Hospital East
Louisville, Kentucky, United States, 40207
United States, Louisiana
Mary Bird Perkins Cancer Ctr
Baton Rouge, Louisiana, United States, 70809
Medical Oncology LLC
Baton Rouge, Louisiana, United States, 70809
Lafayette General Medical Center
Lafayette, Louisiana, United States, 70503-2616
United States, Maine
Mercy Oncology / Hematology Center; Oncology
Portland, Maine, United States, 04102
United States, Maryland
Western Maryland Health Sys
Cumberland, Maryland, United States, 21502
Associates in Oncology/Hematology P.C.
Rockville, Maryland, United States, 20850
Capitol Hematology & Oncology
Silver Spring, Maryland, United States, 20902
St. Joseph Medical Center
Towson, Maryland, United States, 21204
Carroll County Cancer Center
Westminster, Maryland, United States, 21157
United States, Massachusetts
Berkshire Hematology, Oncology Pc
Pittsfeild, Massachusetts, United States, 01201
United States, Michigan
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States, 49503
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
United States, Minnesota
Southdale Cancer Clinic U of M Medical Center, Fairview- Edina
Edina, Minnesota, United States, 55435
Minnesota Oncology Hematology, Pa
Minneapolis, Minnesota, United States, 55407
Park Nicollet Clinic Cancer Center
St Louis Park, Minnesota, United States, 55416
United States, Mississippi
Jackson Oncology Associates, PLLC
Jackson, Mississippi, United States, 39202
United States, Missouri
Jefferson City Medical Group
Jefferson City, Missouri, United States, 65109
Research Medical Center; Pharmacy
Kansas City, Missouri, United States, 64132
Christian Hospital; Outpatient Cancer and Infusion Center
St Louis, Missouri, United States, 63136
St. John'S Mercy Medical Center; David C. Pratt Cancer Center
St Louis, Missouri, United States, 63141
United States, Montana
Billings Clinic Research Center
Billings, Montana, United States, 59101
Montana Cancer Specialists
Missoula, Montana, United States, 59802
United States, Nebraska
Southeast Nebraska Cancer Center;; Southeast Nebraska Hematology and Oncology
Lincoln, Nebraska, United States, 68510
Missouri Valley Cancer Consortium CCOP
Omaha, Nebraska, United States, 68106
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89128
United States, New Hampshire
Dartmouth Hitchcock Medical Center; Gastroenterology Section
Lebanon, New Hampshire, United States, 03756
Portsmouth Regional Hospital; Hem/Onc Clinic
Portsmouth, New Hampshire, United States, 03801
United States, New Jersey
Summit Medical Group
Berkeley Heights, New Jersey, United States, 07922
Onc & Hematology Specialists
Denville, New Jersey, United States, 07834
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Hematology Oncology Associates; Carol G. Simon Ctr
Morristown, New Jersey, United States, 07960
Luckow Pavillion, Valley Hosp; Office of Clinical Trials
Paramus, New Jersey, United States, 07652
United States, New York
The Mary Imogene Bassett Hospi
Cooperstown, New York, United States, 13326
North Shore Hem Onc Associates
East Setauket, New York, United States, 11733
Queens Hospital Center
Jamaica, New York, United States, 11432
Beth Israel Comprehensive Cancer Center Pharmacy
New York, New York, United States, 10011
Herbert Irving Comprehensive Cancer Center; Herbert Irving Pavillion
New York, New York, United States, 10032
United States, North Carolina
Hope A Women's Cancer Center
Asheville, North Carolina, United States, 28806
Gaston Hematology/Oncology
Gastonia, North Carolina, United States, 28054
Cone Health Cancer Center
Greensboro, North Carolina, United States, 27403
Southeastern Regional Medical Center
Lumberton, North Carolina, United States, 28358
First Health of the Carolinas
Pinehurst, North Carolina, United States, 28374
United States, Ohio
Metro Health Medical Center
Cleveland, Ohio, United States, 44109
Mid Ohio Onc Hematology Inc
Columbus, Ohio, United States, 43219
Signal Point Clinical; Research Center, LLC
Middletown, Ohio, United States, 45042
Flower Memorial Hospital
Sylvania, Ohio, United States, 43560
United States, Oklahoma
Mercy Clinic Oklahoma Communties, Inc
Ohlahoma CIty, Oklahoma, United States, 73120
Cancer Care Assoc-15th St
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Providence Cancer Center
Portland, Oregon, United States, 97231
United States, Pennsylvania
Hematology & Oncology Assoc; North Eastern Pennsylvania
Dunmore, Pennsylvania, United States, 18512
Lancaster Cancer Center, Ltd.
Lancaster, Pennsylvania, United States, 17605
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Allegheny General Hospital; Transplantation Services
Pittsburgh, Pennsylvania, United States, 15212
Univ of Pittsburgh Sch of Med; Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Guthrie Clinic
Sayre, Pennsylvania, United States, 18840
United States, South Carolina
Charleston Hematology Oncology
Charleston, South Carolina, United States, 29414
Medical Univ of South Carolina
Charleston, South Carolina, United States, 29425
South Carolina Oncology Associates - SCRI
Columbia, South Carolina, United States, 29210
United States, Tennessee
Chattanooga Oncology and Hematology Associates, PC
Chattanooga, Tennessee, United States, 37404
Kingsport Hematology Oncology Associates
Kingsport, Tennessee, United States, 37660
Center for Biomedical Research LLC
Knoxville, Tennessee, United States, 37909
Boston Baskin Cancer Foundation
Nashville, Tennessee, United States, 37203
Sarah Cannon Research Inst.
Nashville, Tennessee, United States, 37203
United States, Texas
Hendrick Cancer Center
Abilene, Texas, United States, 79601-2301
Texas Oncology
Bedford, Texas, United States, 76022
St. Joseph Regional Cancer Ct
Bryan, Texas, United States, 77802
Texas Oncology-Baylor Sammons Cancer Center
Dallas, Texas, United States, 75246
Texas Oncology- El Paso Cancer Treatment Center Gateway
El Paso, Texas, United States, 79915
Texas Oncology, P.A. - Fort Worth
Fort Worth, Texas, United States, 76104
Texas Oncology - Houston (Gessner)
Houston, Texas, United States, 77024
Texas Oncology, P.A. - McAllen; South Texas Cancer Center-McAllen
McAllen, Texas, United States, 78503
Texas Oncology - Paris
Paris, Texas, United States, 75460
Tyler Hematololgy Oncology, PA
Tyler, Texas, United States, 75701
Texas Oncology, PA
Waco, Texas, United States, 76712
Texas Oncology, P.A.; Duke Slayton Cancer Center
Webster, Texas, United States, 77598-4420
United States, Utah
Northern Utah Associates
Ogden, Utah, United States, 84403
Huntsman Cancer Institute; Oncology
Salt Lake City, Utah, United States, 84112
United States, Virginia
Lynchburg Hem Onc Clinic Inc
Lynchburg, Virginia, United States, 24501
Peninsula Cancer Institute
Newport News, Virginia, United States, 23601
Virginia Cancer Institute
Richmond, Virginia, United States, 23226
Shenandoah Oncology Associates
Winchester, Virginia, United States, 22601
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
United States, West Virginia
West Virginia University Hospitals Inc
Morgantown, West Virginia, United States, 26506-9162
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Columbia Saint Mary's; Medical Oncology
Milwaukee, Wisconsin, United States, 53211
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01615068     History of Changes
Other Study ID Numbers: ML28257
Study First Received: June 6, 2012
Last Updated: April 6, 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 25, 2017