Clinical trial NCT01615068: An Observational Study in Patients With HER2 Positive Metastatic Breast Cancer (SystHERs Registry)
Official title: 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)).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2012-06-08
Enrollment: 1007
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with HER2 positive (HER2+) metastatic breast cancer

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.


Eligibility 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

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