An Observational Study in Patients With HER2 Positive Metastatic Breast Cancer (SystHERs Registry)
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)).
1 other identifier
observational
1,007
1 country
142
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2012
Longer than P75 for all trials
142 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 5, 2012
CompletedFirst Submitted
Initial submission to the registry
June 6, 2012
CompletedFirst Posted
Study publicly available on registry
June 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 16, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 16, 2017
CompletedJuly 16, 2018
July 1, 2018
5.5 years
June 6, 2012
July 12, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Distribution of patients receiving unique treatment regimen/sequence of treatment regimens
Up to 8 years
Secondary Outcomes (7)
Progression-free survival (PFS)
Up to 8 years
Overall survival (OS)
Up to 8 years
Post-progression survival (PPS)
Up to 8 years
Time-to-treatment failure (TTF)
Up to 8 years
Response rate (RR)
Up to 8 years
- +2 more secondary outcomes
Study Arms (1)
Cohort
Eligibility Criteria
Patients with HER2 positive (HER2+) metastatic breast cancer
You may qualify if:
- 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
You may not qualify if:
- Any inability to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (142)
St. Vincent'S Hospital; Birmingham Hematology Oncology Associates, Llc
Birmingham, Alabama, 35205, United States
University of South Alabama; Mitchell Cancer Institute
Mobile, Alabama, 36604, United States
Arizona Oncology Associates, PC - NAHOA
Sedona, Arizona, 86336, United States
Arizona Oncology
Tucson, Arizona, 85704, United States
Genesis Cancer Center
Hot Springs, Arkansas, 71913, United States
NEA Baptist Clinic
Jonesboro, Arkansas, 72401, United States
Hematology Oncology Services of Arkansas
Little Rock, Arkansas, 72205, United States
Highlands Oncology Group
Rogers, Arkansas, 72758, United States
East Valley Hem/Onc Med Group; Metropolitan Hem Onc.
Burbank, California, 91505, United States
South Bay Oncology Hematology Partners
Campbell, California, 95008, United States
California Cancer Associates for Research & Excellence, Inc.
Encinitas, California, 92008, United States
ROBERT A. MOSS, M.D., F.A.C.P., Inc
Fountain Valley, California, 92708-7510, United States
California Oncology of the Central Valley
Fresno, California, 93710, United States
Cancer Care Associates
Fresno, California, 93720, United States
St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr
Fullerton, California, 92835, United States
University of Southern California
Los Angeles, California, 90033, United States
UCLA School of Medicine
Los Angeles, California, 90095, United States
Comprehensive Cancer Care
Palm Springs, California, 92262, United States
Univ of Calif, San Francisco; Breast Cancer Center
San Francisco, California, 94115, United States
Coastal Integrative Cancer Care
San Luis Obispo, California, 93401, United States
Central Coast Medical Oncology
Santa Maria, California, 93454, United States
Sutter Pacific Medical Foundation
Santa Rosa, California, 95403, United States
Kaiser Permanente Of Colorado
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Center - Denver
Denver, Colorado, 80220, United States
Mile High Oncology
Littleton, Colorado, 80122, United States
Connecticut Oncology Group
Middletown, Connecticut, 06457, United States
Yale Cancer Center
New Haven, Connecticut, 06520, United States
Hematology Oncology P.C.
Stamford, Connecticut, 06902, United States
MedStar Washington Hosp Center
Washington D.C., District of Columbia, 20010, United States
Lynn Cancer Institute - West
Boca Raton, Florida, 33428, United States
University of Miami; Dept Sylvester Cancer Center
Deerfield Beach, Florida, 33442, United States
Florida Cancer Specialists - Fort Myers (New Hampshire Ct)
Fort Myers, Florida, 33901-8101, United States
Memorial Cancer Institute
Hollywood, Florida, 33021, United States
Baptist - MD Anderson Cancer Center
Jacksonville, Florida, 32207, United States
Florida Oncology Associates
Jacksonville, Florida, 32256, United States
Lakeland Regional Cancer Center
Lakeland, Florida, 33804-1057, United States
Md Anderson Cancer Center Orlando
Orlando, Florida, 32806, United States
Florida Cancer Research Institute
Plantation, Florida, 33324, United States
Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)
St. Petersburg, Florida, 33705, United States
Space Coast Medical Associates
Titusville, Florida, 32795, United States
Peachtree Hematology & Oncology Consultants, Pc
Atlanta, Georgia, 30318, United States
Northwest Georgia Oncology Centers PC - Marietta
Marietta, Georgia, 30060, United States
Summit Cancer Care PC
Savannah, Georgia, 31405, United States
Kootenai Cancer Center
Post Falls, Idaho, 83854, United States
Alton Memorial Hospital; Outpatient Clinic and Infusion Center
Alton, Illinois, 62002, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Mid-Illinois Hematology
Normal, Illinois, 61761, United States
Oncology Specialists, S.C.
Park Ridge, Illinois, 60068, United States
Orchard Healthcare Research Inc.
Skokie, Illinois, 60076, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Oncology Hematology Assoc
Evansville, Indiana, 47714, United States
McFarland Clinic
Ames, Iowa, 50010, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Mercy Medical Ctr-North Iowa ; Mercy Cancer Center
Mason City, Iowa, 50401, United States
Cancer Center of Kansas
Wichita, Kansas, 67214-3728, United States
James Graham Brown Cancer Center, University of Louisville
Louisville, Kentucky, 40202, United States
Baptist Hospital East
Louisville, Kentucky, 40207, United States
Mary Bird Perkins Cancer Ctr
Baton Rouge, Louisiana, 70809, United States
Medical Oncology LLC
Baton Rouge, Louisiana, 70809, United States
Lafayette General Medical Center
Lafayette, Louisiana, 70503-2616, United States
Mercy Oncology / Hematology Center; Oncology
Portland, Maine, 04102, United States
Western Maryland Health Sys
Cumberland, Maryland, 21502, United States
Associates in Oncology/Hematology P.C.
Rockville, Maryland, 20850, United States
Capitol Hematology & Oncology
Silver Spring, Maryland, 20902, United States
St. Joseph Medical Center
Towson, Maryland, 21204, United States
Carroll County Cancer Center
Westminster, Maryland, 21157, United States
Berkshire Hematology, Oncology Pc
Pittsfield, Massachusetts, 01201, United States
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49503, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Southdale Cancer Clinic U of M Medical Center, Fairview- Edina
Edina, Minnesota, 55435, United States
Minnesota Oncology Hematology, Pa
Minneapolis, Minnesota, 55407, United States
Park Nicollet Clinic Cancer Center
Saint Louis Park, Minnesota, 55416, United States
Jackson Oncology Associates, PLLC
Jackson, Mississippi, 39202, United States
Jefferson City Medical Group
Jefferson City, Missouri, 65109, United States
Research Medical Center; Pharmacy
Kansas City, Missouri, 64132, United States
Christian Hospital; Outpatient Cancer and Infusion Center
St Louis, Missouri, 63136, United States
St. John'S Mercy Medical Center; David C. Pratt Cancer Center
St Louis, Missouri, 63141, United States
Billings Clinic Research Center
Billings, Montana, 59101, United States
Montana Cancer Specialists
Missoula, Montana, 59802, United States
Southeast Nebraska Cancer Center;; Southeast Nebraska Hematology and Oncology
Lincoln, Nebraska, 68510, United States
Cancer Alliance of Nebraska
Omaha, Nebraska, 68106, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89128, United States
Dartmouth Hitchcock Medical Center; Gastroenterology Section
Lebanon, New Hampshire, 03756, United States
Portsmouth Regional Hospital; Hem/Onc Clinic
Portsmouth, New Hampshire, 03801, United States
Summit Medical Group
Berkeley Heights, New Jersey, 07922, United States
Onc & Hematology Specialists
Denville, New Jersey, 07834, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Hematology Oncology Associates; Carol G. Simon Ctr
Morristown, New Jersey, 07960, United States
Luckow Pavillion, Valley Hosp; Office of Clinical Trials
Paramus, New Jersey, 07652, United States
The Mary Imogene Bassett Hospi
Cooperstown, New York, 13326, United States
North Shore Hem Onc Associates
East Setauket, New York, 11733, United States
Queens Hospital Center
Jamaica, New York, 11432, United States
Beth Israel Comprehensive Cancer Center Pharmacy
New York, New York, 10011, United States
Herbert Irving Comprehensive Cancer Center; Herbert Irving Pavillion
New York, New York, 10032, United States
Hope A Women's Cancer Center
Asheville, North Carolina, 28806, United States
Gaston Hematology/Oncology
Gastonia, North Carolina, 28054, United States
Cone Health Cancer Center
Greensboro, North Carolina, 27403, United States
Southeastern Regional Medical Center
Lumberton, North Carolina, 28358, United States
First Health of the Carolinas
Pinehurst, North Carolina, 28374, United States
Metro Health Medical Center
Cleveland, Ohio, 44109, United States
Mid Ohio Onc Hematology Inc
Columbus, Ohio, 43219, United States
Signal Point Clinical; Research Center, LLC
Middletown, Ohio, 45042, United States
Flower Memorial Hospital
Sylvania, Ohio, 43560, United States
Mercy Clinic Oklahoma Communties, Inc
Oklahoma City, Oklahoma, 73120, United States
Cancer Care Assoc-15th St
Tulsa, Oklahoma, 74104, United States
Providence Cancer Center
Portland, Oregon, 97231, United States
Hematology & Oncology Assoc; North Eastern Pennsylvania
Dunmore, Pennsylvania, 18512, United States
Lancaster Cancer Center, Ltd.
Lancaster, Pennsylvania, 17605, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Allegheny General Hospital; Transplantation Services
Pittsburgh, Pennsylvania, 15212, United States
Univ of Pittsburgh Sch of Med; Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
Guthrie Clinic
Sayre, Pennsylvania, 18840, United States
Charleston Hematology Oncology
Charleston, South Carolina, 29414, United States
Medical Univ of South Carolina
Charleston, South Carolina, 29425, United States
South Carolina Oncology Associates - SCRI
Columbia, South Carolina, 29210, United States
Chattanooga Oncology and Hematology Associates, PC
Chattanooga, Tennessee, 37404, United States
Kingsport Hematology Oncology Associates
Kingsport, Tennessee, 37660, United States
Center for Biomedical Research LLC
Knoxville, Tennessee, 37909, United States
Boston Baskin Cancer Foundation
Nashville, Tennessee, 37203, United States
Sarah Cannon Research Inst.
Nashville, Tennessee, 37203, United States
Hendrick Cancer Center
Abilene, Texas, 79601-2301, United States
Texas Oncology
Bedford, Texas, 76022, United States
St. Joseph Regional Cancer Ct
Bryan, Texas, 77802, United States
Texas Oncology-Baylor Sammons Cancer Center
Dallas, Texas, 75246, United States
Texas Oncology- El Paso Cancer Treatment Center Gateway
El Paso, Texas, 79915, United States
Texas Oncology, P.A. - Fort Worth
Fort Worth, Texas, 76104, United States
Texas Oncology - Houston (Gessner)
Houston, Texas, 77024, United States
Texas Oncology, P.A. - McAllen; South Texas Cancer Center-McAllen
McAllen, Texas, 78503, United States
Texas Oncology - Paris
Paris, Texas, 75460, United States
Tyler Hematololgy Oncology, PA
Tyler, Texas, 75701, United States
Texas Oncology, PA
Waco, Texas, 76712, United States
Texas Oncology, P.A.; Duke Slayton Cancer Center
Webster, Texas, 77598-4420, United States
Northern Utah Associates
Ogden, Utah, 84403, United States
Huntsman Cancer Institute; Oncology
Salt Lake City, Utah, 84112, United States
Lynchburg Hem Onc Clinic Inc
Lynchburg, Virginia, 24501, United States
Peninsula Cancer Institute
Newport News, Virginia, 23601, United States
Virginia Cancer Institute
Richmond, Virginia, 23226, United States
Shenandoah Oncology Associates
Winchester, Virginia, 22601, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
West Virginia University Hospitals Inc
Morgantown, West Virginia, 26056, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Columbia Saint Mary's; Medical Oncology
Milwaukee, Wisconsin, 53211, United States
Related Publications (4)
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.
PMID: 32043771DERIVEDCobleigh 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.
PMID: 31772121DERIVEDHurvitz 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.
PMID: 30593513DERIVEDTripathy 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.
PMID: 24885258DERIVED
Biospecimen
Tissue and whole blood samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Genentech, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2012
First Posted
June 8, 2012
Study Start
June 5, 2012
Primary Completion
November 16, 2017
Study Completion
November 16, 2017
Last Updated
July 16, 2018
Record last verified: 2018-07