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

July 12, 2018 updated by: Genentech, Inc.

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)).

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1007

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • St. Vincent'S Hospital; Birmingham Hematology Oncology Associates, Llc
      • Mobile, Alabama, United States, 36604
        • University of South Alabama; Mitchell Cancer Institute
    • Arizona
      • Sedona, Arizona, United States, 86336
        • Arizona Oncology Associates, PC - NAHOA
      • Tucson, Arizona, United States, 85704
        • Arizona Oncology
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Genesis Cancer Center
      • Jonesboro, Arkansas, United States, 72401
        • NEA Baptist Clinic
      • Little Rock, Arkansas, United States, 72205
        • Hematology Oncology Services of Arkansas
      • Rogers, Arkansas, United States, 72758
        • Highlands Oncology Group
    • California
      • Burbank, California, United States, 91505
        • East Valley Hem/Onc Med Group; Metropolitan Hem Onc.
      • Campbell, California, United States, 95008
        • South Bay Oncology Hematology Partners
      • Encinitas, California, United States, 92008
        • California Cancer Associates for Research & Excellence, Inc.
      • Fountain Valley, California, United States, 92708-7510
        • ROBERT A. MOSS, M.D., F.A.C.P., Inc
      • Fresno, California, United States, 93720
        • Cancer Care Associates
      • Fresno, California, United States, 93710
        • California Oncology of the Central Valley
      • Fullerton, California, United States, 92835
        • St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr
      • Los Angeles, California, United States, 90033
        • University of Southern California
      • Los Angeles, California, United States, 90095
        • UCLA School of Medicine
      • Palm Springs, California, United States, 92262
        • Comprehensive Cancer Care
      • San Francisco, California, United States, 94115
        • Univ of Calif, San Francisco; Breast Cancer Center
      • San Luis Obispo, California, United States, 93401
        • Coastal Integrative Cancer Care
      • Santa Maria, California, United States, 93454
        • Central Coast Medical Oncology
      • Santa Rosa, California, United States, 95403
        • Sutter Pacific Medical Foundation
    • Colorado
      • Denver, Colorado, United States, 80220
        • Rocky Mountain Cancer Center - Denver
      • Denver, Colorado, United States, 80218
        • Kaiser Permanente of Colorado
      • Littleton, Colorado, United States, 80122
        • Mile High Oncology
    • Connecticut
      • Middletown, Connecticut, United States, 06457
        • Connecticut Oncology Group
      • New Haven, Connecticut, United States, 06520
        • Yale Cancer Center
      • Stamford, Connecticut, United States, 06902
        • Hematology Oncology P.C.
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • MedStar Washington Hosp Center
    • Florida
      • Boca Raton, Florida, United States, 33428
        • Lynn Cancer Institute - West
      • Deerfield Beach, Florida, United States, 33442
        • University of Miami; Dept Sylvester Cancer Center
      • Fort Myers, Florida, United States, 33901-8101
        • Florida Cancer Specialists - Fort Myers (New Hampshire Ct)
      • Hollywood, Florida, United States, 33021
        • Memorial Cancer Institute
      • Jacksonville, Florida, United States, 32207
        • Baptist - MD Anderson Cancer Center
      • Jacksonville, Florida, United States, 32256
        • Florida Oncology Associates
      • Lakeland, Florida, United States, 33804-1057
        • Lakeland Regional Cancer Center
      • Orlando, Florida, United States, 32806
        • MD Anderson Cancer Center Orlando
      • Plantation, Florida, United States, 33324
        • Florida Cancer Research Institute
      • Saint Petersburg, Florida, United States, 33705
        • Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)
      • Titusville, Florida, United States, 32795
        • Space Coast Medical Associates
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Peachtree Hematology & Oncology Consultants, Pc
      • Marietta, Georgia, United States, 30060
        • Northwest Georgia Oncology Centers PC - Marietta
      • Savannah, Georgia, United States, 31405
        • Summit Cancer Care PC
    • Idaho
      • Post Falls, Idaho, United States, 83854
        • Kootenai Cancer Center
    • Illinois
      • Alton, Illinois, United States, 62002
        • Alton Memorial Hospital; Outpatient Clinic and Infusion Center
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Normal, Illinois, United States, 61761
        • Mid-Illinois Hematology
      • Park Ridge, Illinois, United States, 60068
        • Oncology Specialists, S.C.
      • Skokie, Illinois, United States, 60076
        • Orchard Healthcare Research Inc.
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Oncology Hematology Assoc
    • Iowa
      • Ames, Iowa, United States, 50010
        • McFarland Clinic
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
      • Mason City, Iowa, United States, 50401
        • Mercy Medical Ctr-North Iowa ; Mercy Cancer Center
    • Kansas
      • Wichita, Kansas, United States, 67214-3728
        • Cancer Center of Kansas
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Baptist Hospital East
      • Louisville, Kentucky, United States, 40202
        • James Graham Brown Cancer Center, University of Louisville
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Medical Oncology LLC
      • Baton Rouge, Louisiana, United States, 70809
        • Mary Bird Perkins Cancer Ctr
      • Lafayette, Louisiana, United States, 70503-2616
        • Lafayette General Medical Center
    • Maine
      • Portland, Maine, United States, 04102
        • Mercy Oncology / Hematology Center; Oncology
    • Maryland
      • Cumberland, Maryland, United States, 21502
        • Western Maryland Health Sys
      • Rockville, Maryland, United States, 20850
        • Associates in Oncology/Hematology P.C.
      • Silver Spring, Maryland, United States, 20902
        • Capitol Hematology & Oncology
      • Towson, Maryland, United States, 21204
        • St. Joseph Medical Center
      • Westminster, Maryland, United States, 21157
        • Carroll County Cancer Center
    • Massachusetts
      • Pittsfield, Massachusetts, United States, 01201
        • Berkshire Hematology, Oncology Pc
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Cancer & Hematology Centers of Western Michigan
      • Kalamazoo, Michigan, United States, 49007
        • West Michigan Cancer Center
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Southdale Cancer Clinic U of M Medical Center, Fairview- Edina
      • Minneapolis, Minnesota, United States, 55407
        • Minnesota Oncology Hematology, PA
      • Saint Louis Park, Minnesota, United States, 55416
        • Park Nicollet Clinic Cancer Center
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Jackson Oncology Associates, PLLC
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Jefferson City Medical Group
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center; Pharmacy
      • Saint Louis, Missouri, United States, 63141
        • St. John'S Mercy Medical Center; David C. Pratt Cancer Center
      • Saint Louis, Missouri, United States, 63136
        • Christian Hospital; Outpatient Cancer and Infusion Center
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic Research Center
      • Missoula, Montana, United States, 59802
        • Montana Cancer Specialists
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Southeast Nebraska Cancer Center;; Southeast Nebraska Hematology and Oncology
      • Omaha, Nebraska, United States, 68106
        • Cancer Alliance of Nebraska
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Comprehensive Cancer Centers of Nevada
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center; Gastroenterology Section
      • Portsmouth, New Hampshire, United States, 03801
        • Portsmouth Regional Hospital; Hem/Onc Clinic
    • New Jersey
      • Berkeley Heights, New Jersey, United States, 07922
        • Summit Medical Group
      • Denville, New Jersey, United States, 07834
        • Onc & Hematology Specialists
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • Morristown, New Jersey, United States, 07960
        • Hematology Oncology Associates; Carol G. Simon Ctr
      • Paramus, New Jersey, United States, 07652
        • Luckow Pavillion, Valley Hosp; Office of Clinical Trials
    • New York
      • Cooperstown, New York, United States, 13326
        • The Mary Imogene Bassett Hospi
      • East Setauket, New York, United States, 11733
        • North Shore Hem Onc Associates
      • Jamaica, New York, United States, 11432
        • Queens Hospital Center
      • New York, New York, United States, 10032
        • Herbert Irving Comprehensive Cancer Center; Herbert Irving Pavillion
      • New York, New York, United States, 10011
        • Beth Israel Comprehensive Cancer Center Pharmacy
    • North Carolina
      • Asheville, North Carolina, United States, 28806
        • Hope A Women's Cancer Center
      • Gastonia, North Carolina, United States, 28054
        • Gaston Hematology/Oncology
      • Greensboro, North Carolina, United States, 27403
        • Cone Health Cancer Center
      • Lumberton, North Carolina, United States, 28358
        • Southeastern Regional Medical Center
      • Pinehurst, North Carolina, United States, 28374
        • First Health of the Carolinas
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • Metro Health Medical Center
      • Columbus, Ohio, United States, 43219
        • Mid Ohio Onc Hematology Inc
      • Middletown, Ohio, United States, 45042
        • Signal Point Clinical; Research Center, LLC
      • Sylvania, Ohio, United States, 43560
        • Flower Memorial Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Mercy Clinic Oklahoma Communties, Inc
      • Tulsa, Oklahoma, United States, 74104
        • Cancer Care Assoc-15th St
    • Oregon
      • Portland, Oregon, United States, 97231
        • Providence Cancer Center
    • Pennsylvania
      • Dunmore, Pennsylvania, United States, 18512
        • Hematology & Oncology Assoc; North Eastern Pennsylvania
      • Lancaster, Pennsylvania, United States, 17605
        • Lancaster Cancer Center, Ltd.
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • Univ of Pittsburgh Sch of Med; Magee-Womens Hospital
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital; Transplantation Services
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Clinic
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Charleston Hematology Oncology
      • Charleston, South Carolina, United States, 29425
        • Medical Univ Of South Carolina
      • Columbia, South Carolina, United States, 29210
        • South Carolina Oncology Associates - SCRI
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga Oncology and Hematology Associates, PC
      • Kingsport, Tennessee, United States, 37660
        • Kingsport Hematology Oncology Associates
      • Knoxville, Tennessee, United States, 37909
        • Center for Biomedical Research LLC
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Inst.
      • Nashville, Tennessee, United States, 37203
        • Boston Baskin Cancer Foundation
    • Texas
      • Abilene, Texas, United States, 79601-2301
        • Hendrick Cancer Center
      • Bedford, Texas, United States, 76022
        • Texas Oncology
      • Bryan, Texas, United States, 77802
        • St. Joseph Regional Cancer Ct
      • Dallas, Texas, United States, 75246
        • Texas Oncology-Baylor Sammons Cancer Center
      • El Paso, Texas, United States, 79915
        • Texas Oncology- El Paso Cancer Treatment Center Gateway
      • Fort Worth, Texas, United States, 76104
        • Texas Oncology, P.A. - Fort Worth
      • Houston, Texas, United States, 77024
        • Texas Oncology - Houston (Gessner)
      • McAllen, Texas, United States, 78503
        • Texas Oncology, P.A. - McAllen; South Texas Cancer Center-McAllen
      • Paris, Texas, United States, 75460
        • Texas Oncology - Paris
      • Tyler, Texas, United States, 75701
        • Tyler Hematololgy Oncology, PA
      • Waco, Texas, United States, 76712
        • Texas Oncology, PA
      • Webster, Texas, United States, 77598-4420
        • Texas Oncology, P.A.; Duke Slayton Cancer Center
    • Utah
      • Ogden, Utah, United States, 84403
        • Northern Utah Associates
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute; Oncology
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • Lynchburg Hem Onc Clinic Inc
      • Newport News, Virginia, United States, 23601
        • Peninsula Cancer Institute
      • Richmond, Virginia, United States, 23226
        • Virginia Cancer Institute
      • Winchester, Virginia, United States, 22601
        • Shenandoah Oncology Associates
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26056
        • West Virginia University Hospitals Inc
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin
      • Milwaukee, Wisconsin, United States, 53211
        • Columbia Saint Mary's; Medical Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with HER2 positive (HER2+) metastatic breast cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Distribution of patients receiving unique treatment regimen/sequence of treatment regimens
Time Frame: Up to 8 years
Up to 8 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2012

Primary Completion (Actual)

November 16, 2017

Study Completion (Actual)

November 16, 2017

Study Registration Dates

First Submitted

June 6, 2012

First Submitted That Met QC Criteria

June 7, 2012

First Posted (Estimate)

June 8, 2012

Study Record Updates

Last Update Posted (Actual)

July 16, 2018

Last Update Submitted That Met QC Criteria

July 12, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML28257

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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