An Observational Study in Patients With HER2 Positive Metastatic Breast Cancer (SystHERs Registry)
- Conditions
- Breast Cancer
- Registration Number
- NCT01615068
- Lead Sponsor
- Genentech, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1007
- 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
- Any inability to provide informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Distribution of patients receiving unique treatment regimen/sequence of treatment regimens Up to 8 years
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) Up to 8 years Time-to-treatment failure (TTF) Up to 8 years Post-progression survival (PPS) Up to 8 years Patient-reported outcome assessment (PRO) Up to 8 years Overall survival (OS) Up to 8 years Response rate (RR) Up to 8 years Safety: Incidence of adverse events Up to 8 years
Trial Locations
- Locations (142)
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Allegheny General Hospital; Transplantation Services
🇺🇸Pittsburgh, Pennsylvania, United States
Univ of Pittsburgh Sch of Med; Magee-Womens Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Boston Baskin Cancer Foundation
🇺🇸Nashville, Tennessee, United States
Huntsman Cancer Institute; Oncology
🇺🇸Salt Lake City, Utah, United States
Mercy Clinic Oklahoma Communties, Inc
🇺🇸Oklahoma City, Oklahoma, United States
Sarah Cannon Research Inst.
🇺🇸Nashville, Tennessee, United States
Kaiser Permanente Of Colorado
🇺🇸Denver, Colorado, United States
Providence Cancer Center
🇺🇸Portland, Oregon, United States
Cancer Care Associates
🇺🇸Fresno, California, United States
Rocky Mountain Cancer Center - Denver
🇺🇸Denver, Colorado, United States
St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr
🇺🇸Fullerton, California, United States
California Oncology of the Central Valley
🇺🇸Fresno, California, United States
Arizona Oncology Associates, PC - NAHOA
🇺🇸Sedona, Arizona, United States
Coastal Integrative Cancer Care
🇺🇸San Luis Obispo, California, United States
Hematology Oncology P.C.
🇺🇸Stamford, Connecticut, United States
Arizona Oncology
🇺🇸Tucson, Arizona, United States
St. Vincent'S Hospital; Birmingham Hematology Oncology Associates, Llc
🇺🇸Birmingham, Alabama, United States
South Bay Oncology Hematology Partners
🇺🇸Campbell, California, United States
California Cancer Associates for Research & Excellence, Inc.
🇺🇸Encinitas, California, United States
ROBERT A. MOSS, M.D., F.A.C.P., Inc
🇺🇸Fountain Valley, California, United States
NEA Baptist Clinic
🇺🇸Jonesboro, Arkansas, United States
Connecticut Oncology Group
🇺🇸Middletown, Connecticut, United States
Univ of Calif, San Francisco; Breast Cancer Center
🇺🇸San Francisco, California, United States
Lynn Cancer Institute - West
🇺🇸Boca Raton, Florida, United States
Northwest Georgia Oncology Centers PC - Marietta
🇺🇸Marietta, Georgia, United States
Orchard Healthcare Research Inc.
🇺🇸Skokie, Illinois, United States
University of Miami; Dept Sylvester Cancer Center
🇺🇸Deerfield Beach, Florida, United States
Central Coast Medical Oncology
🇺🇸Santa Maria, California, United States
Lakeland Regional Cancer Center
🇺🇸Lakeland, Florida, United States
Baptist - MD Anderson Cancer Center
🇺🇸Jacksonville, Florida, United States
Genesis Cancer Center
🇺🇸Hot Springs, Arkansas, United States
UCLA School of Medicine
🇺🇸Los Angeles, California, United States
Minnesota Oncology Hematology, Pa
🇺🇸Minneapolis, Minnesota, United States
University of South Alabama; Mitchell Cancer Institute
🇺🇸Mobile, Alabama, United States
East Valley Hem/Onc Med Group; Metropolitan Hem Onc.
🇺🇸Burbank, California, United States
Memorial Cancer Institute
🇺🇸Hollywood, Florida, United States
Mary Bird Perkins Cancer Ctr
🇺🇸Baton Rouge, Louisiana, United States
Medical Oncology LLC
🇺🇸Baton Rouge, Louisiana, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Hematology Oncology Services of Arkansas
🇺🇸Little Rock, Arkansas, United States
Florida Oncology Associates
🇺🇸Jacksonville, Florida, United States
Cancer Center of Kansas
🇺🇸Wichita, Kansas, United States
Highlands Oncology Group
🇺🇸Rogers, Arkansas, United States
Comprehensive Cancer Care
🇺🇸Palm Springs, California, United States
McFarland Clinic
🇺🇸Ames, Iowa, United States
Berkshire Hematology, Oncology Pc
🇺🇸Pittsfield, Massachusetts, United States
Southdale Cancer Clinic U of M Medical Center, Fairview- Edina
🇺🇸Edina, Minnesota, United States
MedStar Washington Hosp Center
🇺🇸Washington, District of Columbia, United States
Western Maryland Health Sys
🇺🇸Cumberland, Maryland, United States
Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)
🇺🇸Saint Petersburg, Florida, United States
Alton Memorial Hospital; Outpatient Clinic and Infusion Center
🇺🇸Alton, Illinois, United States
Summit Cancer Care PC
🇺🇸Savannah, Georgia, United States
Oncology Specialists, S.C.
🇺🇸Park Ridge, Illinois, United States
Southeastern Regional Medical Center
🇺🇸Lumberton, North Carolina, United States
St. Joseph Medical Center
🇺🇸Towson, Maryland, United States
Portsmouth Regional Hospital; Hem/Onc Clinic
🇺🇸Portsmouth, New Hampshire, United States
Summit Medical Group
🇺🇸Berkeley Heights, New Jersey, United States
North Shore Hem Onc Associates
🇺🇸East Setauket, New York, United States
Gaston Hematology/Oncology
🇺🇸Gastonia, North Carolina, United States
Space Coast Medical Associates
🇺🇸Titusville, Florida, United States
St. John'S Mercy Medical Center; David C. Pratt Cancer Center
🇺🇸Saint Louis, Missouri, United States
Onc & Hematology Specialists
🇺🇸Denville, New Jersey, United States
Florida Cancer Specialists - Fort Myers (New Hampshire Ct)
🇺🇸Fort Myers, Florida, United States
Florida Cancer Research Institute
🇺🇸Plantation, Florida, United States
Mercy Oncology / Hematology Center; Oncology
🇺🇸Portland, Maine, United States
Park Nicollet Clinic Cancer Center
🇺🇸Saint Louis Park, Minnesota, United States
Southeast Nebraska Cancer Center;; Southeast Nebraska Hematology and Oncology
🇺🇸Lincoln, Nebraska, United States
First Health of the Carolinas
🇺🇸Pinehurst, North Carolina, United States
Peachtree Hematology & Oncology Consultants, Pc
🇺🇸Atlanta, Georgia, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Mid-Illinois Hematology
🇺🇸Normal, Illinois, United States
Lafayette General Medical Center
🇺🇸Lafayette, Louisiana, United States
Capitol Hematology & Oncology
🇺🇸Silver Spring, Maryland, United States
Luckow Pavillion, Valley Hosp; Office of Clinical Trials
🇺🇸Paramus, New Jersey, United States
Queens Hospital Center
🇺🇸Jamaica, New York, United States
Flower Memorial Hospital
🇺🇸Sylvania, Ohio, United States
Christian Hospital; Outpatient Cancer and Infusion Center
🇺🇸Saint Louis, Missouri, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Beth Israel Comprehensive Cancer Center Pharmacy
🇺🇸New York, New York, United States
Herbert Irving Comprehensive Cancer Center; Herbert Irving Pavillion
🇺🇸New York, New York, United States
Montana Cancer Specialists
🇺🇸Missoula, Montana, United States
Cancer & Hematology Centers of Western Michigan
🇺🇸Grand Rapids, Michigan, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Hope A Women's Cancer Center
🇺🇸Asheville, North Carolina, United States
Cancer Care Assoc-15th St
🇺🇸Tulsa, Oklahoma, United States
South Carolina Oncology Associates - SCRI
🇺🇸Columbia, South Carolina, United States
Center for Biomedical Research LLC
🇺🇸Knoxville, Tennessee, United States
Kootenai Cancer Center
🇺🇸Post Falls, Idaho, United States
Carroll County Cancer Center
🇺🇸Westminster, Maryland, United States
Billings Clinic Research Center
🇺🇸Billings, Montana, United States
Mercy Medical Ctr-North Iowa ; Mercy Cancer Center
🇺🇸Mason City, Iowa, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Oncology Hematology Assoc
🇺🇸Evansville, Indiana, United States
Associates in Oncology/Hematology P.C.
🇺🇸Rockville, Maryland, United States
Jefferson City Medical Group
🇺🇸Jefferson City, Missouri, United States
Metro Health Medical Center
🇺🇸Cleveland, Ohio, United States
The Mary Imogene Bassett Hospi
🇺🇸Cooperstown, New York, United States
Hematology & Oncology Assoc; North Eastern Pennsylvania
🇺🇸Dunmore, Pennsylvania, United States
Texas Oncology, PA
🇺🇸Waco, Texas, United States
Jackson Oncology Associates, PLLC
🇺🇸Jackson, Mississippi, United States
Texas Oncology, P.A. - Fort Worth
🇺🇸Fort Worth, Texas, United States
Texas Oncology-Baylor Sammons Cancer Center
🇺🇸Dallas, Texas, United States
Mid Ohio Onc Hematology Inc
🇺🇸Columbus, Ohio, United States
Hematology Oncology Associates; Carol G. Simon Ctr
🇺🇸Morristown, New Jersey, United States
Cone Health Cancer Center
🇺🇸Greensboro, North Carolina, United States
St. Joseph Regional Cancer Ct
🇺🇸Bryan, Texas, United States
Dartmouth Hitchcock Medical Center; Gastroenterology Section
🇺🇸Lebanon, New Hampshire, United States
Chattanooga Oncology and Hematology Associates, PC
🇺🇸Chattanooga, Tennessee, United States
Guthrie Clinic
🇺🇸Sayre, Pennsylvania, United States
Texas Oncology - Houston (Gessner)
🇺🇸Houston, Texas, United States
Hendrick Cancer Center
🇺🇸Abilene, Texas, United States
Texas Oncology - Paris
🇺🇸Paris, Texas, United States
Tyler Hematololgy Oncology, PA
🇺🇸Tyler, Texas, United States
Northern Utah Associates
🇺🇸Ogden, Utah, United States
Texas Oncology, P.A.; Duke Slayton Cancer Center
🇺🇸Webster, Texas, United States
West Virginia University Hospitals Inc
🇺🇸Morgantown, West Virginia, United States
Lynchburg Hem Onc Clinic Inc
🇺🇸Lynchburg, Virginia, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Peninsula Cancer Institute
🇺🇸Newport News, Virginia, United States
Shenandoah Oncology Associates
🇺🇸Winchester, Virginia, United States
Cancer Alliance of Nebraska
🇺🇸Omaha, Nebraska, United States
Columbia Saint Mary's; Medical Oncology
🇺🇸Milwaukee, Wisconsin, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Kingsport Hematology Oncology Associates
🇺🇸Kingsport, Tennessee, United States
Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Baptist Hospital East
🇺🇸Louisville, Kentucky, United States
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
Md Anderson Cancer Center Orlando
🇺🇸Orlando, Florida, United States
James Graham Brown Cancer Center, University of Louisville
🇺🇸Louisville, Kentucky, United States
Research Medical Center; Pharmacy
🇺🇸Kansas City, Missouri, United States
Charleston Hematology Oncology
🇺🇸Charleston, South Carolina, United States
Medical Univ of South Carolina
🇺🇸Charleston, South Carolina, United States
Virginia Cancer Institute
🇺🇸Richmond, Virginia, United States
Lancaster Cancer Center, Ltd.
🇺🇸Lancaster, Pennsylvania, United States
Texas Oncology
🇺🇸Bedford, Texas, United States
Texas Oncology- El Paso Cancer Treatment Center Gateway
🇺🇸El Paso, Texas, United States
Signal Point Clinical; Research Center, LLC
🇺🇸Middletown, Ohio, United States
Texas Oncology, P.A. - McAllen; South Texas Cancer Center-McAllen
🇺🇸McAllen, Texas, United States
Sutter Pacific Medical Foundation
🇺🇸Santa Rosa, California, United States
Mile High Oncology
🇺🇸Littleton, Colorado, United States