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

NCT ID: NCT01615068

Last Updated: 2018-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1007 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-05

Study Completion Date

2017-11-16

Brief Summary

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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

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

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St. Vincent'S Hospital; Birmingham Hematology Oncology Associates, Llc

Birmingham, Alabama, United States

Site Status

University of South Alabama; Mitchell Cancer Institute

Mobile, Alabama, United States

Site Status

Arizona Oncology Associates, PC - NAHOA

Sedona, Arizona, United States

Site Status

Arizona Oncology

Tucson, Arizona, United States

Site Status

Genesis Cancer Center

Hot Springs, Arkansas, United States

Site Status

NEA Baptist Clinic

Jonesboro, Arkansas, United States

Site Status

Hematology Oncology Services of Arkansas

Little Rock, Arkansas, United States

Site Status

Highlands Oncology Group

Rogers, Arkansas, United States

Site Status

East Valley Hem/Onc Med Group; Metropolitan Hem Onc.

Burbank, California, United States

Site Status

South Bay Oncology Hematology Partners

Campbell, California, United States

Site Status

California Cancer Associates for Research & Excellence, Inc.

Encinitas, California, United States

Site Status

ROBERT A. MOSS, M.D., F.A.C.P., Inc

Fountain Valley, California, United States

Site Status

California Oncology of the Central Valley

Fresno, California, United States

Site Status

Cancer Care Associates

Fresno, California, United States

Site Status

St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr

Fullerton, California, United States

Site Status

University of Southern California

Los Angeles, California, United States

Site Status

UCLA School of Medicine

Los Angeles, California, United States

Site Status

Comprehensive Cancer Care

Palm Springs, California, United States

Site Status

Univ of Calif, San Francisco; Breast Cancer Center

San Francisco, California, United States

Site Status

Coastal Integrative Cancer Care

San Luis Obispo, California, United States

Site Status

Central Coast Medical Oncology

Santa Maria, California, United States

Site Status

Sutter Pacific Medical Foundation

Santa Rosa, California, United States

Site Status

Kaiser Permanente Of Colorado

Denver, Colorado, United States

Site Status

Rocky Mountain Cancer Center - Denver

Denver, Colorado, United States

Site Status

Mile High Oncology

Littleton, Colorado, United States

Site Status

Connecticut Oncology Group

Middletown, Connecticut, United States

Site Status

Yale Cancer Center

New Haven, Connecticut, United States

Site Status

Hematology Oncology P.C.

Stamford, Connecticut, United States

Site Status

MedStar Washington Hosp Center

Washington D.C., District of Columbia, United States

Site Status

Lynn Cancer Institute - West

Boca Raton, Florida, United States

Site Status

University of Miami; Dept Sylvester Cancer Center

Deerfield Beach, Florida, United States

Site Status

Florida Cancer Specialists - Fort Myers (New Hampshire Ct)

Fort Myers, Florida, United States

Site Status

Memorial Cancer Institute

Hollywood, Florida, United States

Site Status

Baptist - MD Anderson Cancer Center

Jacksonville, Florida, United States

Site Status

Florida Oncology Associates

Jacksonville, Florida, United States

Site Status

Lakeland Regional Cancer Center

Lakeland, Florida, United States

Site Status

Md Anderson Cancer Center Orlando

Orlando, Florida, United States

Site Status

Florida Cancer Research Institute

Plantation, Florida, United States

Site Status

Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)

St. Petersburg, Florida, United States

Site Status

Space Coast Medical Associates

Titusville, Florida, United States

Site Status

Peachtree Hematology & Oncology Consultants, Pc

Atlanta, Georgia, United States

Site Status

Northwest Georgia Oncology Centers PC - Marietta

Marietta, Georgia, United States

Site Status

Summit Cancer Care PC

Savannah, Georgia, United States

Site Status

Kootenai Cancer Center

Post Falls, Idaho, United States

Site Status

Alton Memorial Hospital; Outpatient Clinic and Infusion Center

Alton, Illinois, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

Mid-Illinois Hematology

Normal, Illinois, United States

Site Status

Oncology Specialists, S.C.

Park Ridge, Illinois, United States

Site Status

Orchard Healthcare Research Inc.

Skokie, Illinois, United States

Site Status

Carle Cancer Center

Urbana, Illinois, United States

Site Status

Oncology Hematology Assoc

Evansville, Indiana, United States

Site Status

McFarland Clinic

Ames, Iowa, United States

Site Status

University of Iowa

Iowa City, Iowa, United States

Site Status

Mercy Medical Ctr-North Iowa ; Mercy Cancer Center

Mason City, Iowa, United States

Site Status

Cancer Center of Kansas

Wichita, Kansas, United States

Site Status

James Graham Brown Cancer Center, University of Louisville

Louisville, Kentucky, United States

Site Status

Baptist Hospital East

Louisville, Kentucky, United States

Site Status

Mary Bird Perkins Cancer Ctr

Baton Rouge, Louisiana, United States

Site Status

Medical Oncology LLC

Baton Rouge, Louisiana, United States

Site Status

Lafayette General Medical Center

Lafayette, Louisiana, United States

Site Status

Mercy Oncology / Hematology Center; Oncology

Portland, Maine, United States

Site Status

Western Maryland Health Sys

Cumberland, Maryland, United States

Site Status

Associates in Oncology/Hematology P.C.

Rockville, Maryland, United States

Site Status

Capitol Hematology & Oncology

Silver Spring, Maryland, United States

Site Status

St. Joseph Medical Center

Towson, Maryland, United States

Site Status

Carroll County Cancer Center

Westminster, Maryland, United States

Site Status

Berkshire Hematology, Oncology Pc

Pittsfield, Massachusetts, United States

Site Status

Cancer & Hematology Centers of Western Michigan

Grand Rapids, Michigan, United States

Site Status

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Site Status

Southdale Cancer Clinic U of M Medical Center, Fairview- Edina

Edina, Minnesota, United States

Site Status

Minnesota Oncology Hematology, Pa

Minneapolis, Minnesota, United States

Site Status

Park Nicollet Clinic Cancer Center

Saint Louis Park, Minnesota, United States

Site Status

Jackson Oncology Associates, PLLC

Jackson, Mississippi, United States

Site Status

Jefferson City Medical Group

Jefferson City, Missouri, United States

Site Status

Research Medical Center; Pharmacy

Kansas City, Missouri, United States

Site Status

Christian Hospital; Outpatient Cancer and Infusion Center

St Louis, Missouri, United States

Site Status

St. John'S Mercy Medical Center; David C. Pratt Cancer Center

St Louis, Missouri, United States

Site Status

Billings Clinic Research Center

Billings, Montana, United States

Site Status

Montana Cancer Specialists

Missoula, Montana, United States

Site Status

Southeast Nebraska Cancer Center;; Southeast Nebraska Hematology and Oncology

Lincoln, Nebraska, United States

Site Status

Cancer Alliance of Nebraska

Omaha, Nebraska, United States

Site Status

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Site Status

Dartmouth Hitchcock Medical Center; Gastroenterology Section

Lebanon, New Hampshire, United States

Site Status

Portsmouth Regional Hospital; Hem/Onc Clinic

Portsmouth, New Hampshire, United States

Site Status

Summit Medical Group

Berkeley Heights, New Jersey, United States

Site Status

Onc & Hematology Specialists

Denville, New Jersey, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

Hematology Oncology Associates; Carol G. Simon Ctr

Morristown, New Jersey, United States

Site Status

Luckow Pavillion, Valley Hosp; Office of Clinical Trials

Paramus, New Jersey, United States

Site Status

The Mary Imogene Bassett Hospi

Cooperstown, New York, United States

Site Status

North Shore Hem Onc Associates

East Setauket, New York, United States

Site Status

Queens Hospital Center

Jamaica, New York, United States

Site Status

Beth Israel Comprehensive Cancer Center Pharmacy

New York, New York, United States

Site Status

Herbert Irving Comprehensive Cancer Center; Herbert Irving Pavillion

New York, New York, United States

Site Status

Hope A Women's Cancer Center

Asheville, North Carolina, United States

Site Status

Gaston Hematology/Oncology

Gastonia, North Carolina, United States

Site Status

Cone Health Cancer Center

Greensboro, North Carolina, United States

Site Status

Southeastern Regional Medical Center

Lumberton, North Carolina, United States

Site Status

First Health of the Carolinas

Pinehurst, North Carolina, United States

Site Status

Metro Health Medical Center

Cleveland, Ohio, United States

Site Status

Mid Ohio Onc Hematology Inc

Columbus, Ohio, United States

Site Status

Signal Point Clinical; Research Center, LLC

Middletown, Ohio, United States

Site Status

Flower Memorial Hospital

Sylvania, Ohio, United States

Site Status

Mercy Clinic Oklahoma Communties, Inc

Oklahoma City, Oklahoma, United States

Site Status

Cancer Care Assoc-15th St

Tulsa, Oklahoma, United States

Site Status

Providence Cancer Center

Portland, Oregon, United States

Site Status

Hematology & Oncology Assoc; North Eastern Pennsylvania

Dunmore, Pennsylvania, United States

Site Status

Lancaster Cancer Center, Ltd.

Lancaster, Pennsylvania, United States

Site Status

Temple University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Allegheny General Hospital; Transplantation Services

Pittsburgh, Pennsylvania, United States

Site Status

Univ of Pittsburgh Sch of Med; Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Guthrie Clinic

Sayre, Pennsylvania, United States

Site Status

Charleston Hematology Oncology

Charleston, South Carolina, United States

Site Status

Medical Univ of South Carolina

Charleston, South Carolina, United States

Site Status

South Carolina Oncology Associates - SCRI

Columbia, South Carolina, United States

Site Status

Chattanooga Oncology and Hematology Associates, PC

Chattanooga, Tennessee, United States

Site Status

Kingsport Hematology Oncology Associates

Kingsport, Tennessee, United States

Site Status

Center for Biomedical Research LLC

Knoxville, Tennessee, United States

Site Status

Boston Baskin Cancer Foundation

Nashville, Tennessee, United States

Site Status

Sarah Cannon Research Inst.

Nashville, Tennessee, United States

Site Status

Hendrick Cancer Center

Abilene, Texas, United States

Site Status

Texas Oncology

Bedford, Texas, United States

Site Status

St. Joseph Regional Cancer Ct

Bryan, Texas, United States

Site Status

Texas Oncology-Baylor Sammons Cancer Center

Dallas, Texas, United States

Site Status

Texas Oncology- El Paso Cancer Treatment Center Gateway

El Paso, Texas, United States

Site Status

Texas Oncology, P.A. - Fort Worth

Fort Worth, Texas, United States

Site Status

Texas Oncology - Houston (Gessner)

Houston, Texas, United States

Site Status

Texas Oncology, P.A. - McAllen; South Texas Cancer Center-McAllen

McAllen, Texas, United States

Site Status

Texas Oncology - Paris

Paris, Texas, United States

Site Status

Tyler Hematololgy Oncology, PA

Tyler, Texas, United States

Site Status

Texas Oncology, PA

Waco, Texas, United States

Site Status

Texas Oncology, P.A.; Duke Slayton Cancer Center

Webster, Texas, United States

Site Status

Northern Utah Associates

Ogden, Utah, United States

Site Status

Huntsman Cancer Institute; Oncology

Salt Lake City, Utah, United States

Site Status

Lynchburg Hem Onc Clinic Inc

Lynchburg, Virginia, United States

Site Status

Peninsula Cancer Institute

Newport News, Virginia, United States

Site Status

Virginia Cancer Institute

Richmond, Virginia, United States

Site Status

Shenandoah Oncology Associates

Winchester, Virginia, United States

Site Status

Virginia Mason Medical Center

Seattle, Washington, United States

Site Status

West Virginia University Hospitals Inc

Morgantown, West Virginia, United States

Site Status

University of Wisconsin

Madison, Wisconsin, United States

Site Status

Columbia Saint Mary's; Medical Oncology

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32043771 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31772121 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30593513 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24885258 (View on PubMed)

Other Identifiers

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ML28257

Identifier Type: -

Identifier Source: org_study_id

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