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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Genentech, Inc.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01615068
First received: June 6, 2012
Last updated: November 4, 2014
Last verified: November 2014
  Purpose

This multi-center, prospective observational study will evaluate the treatment p atterns, and the safety in patients with HER2-positive (HER2+) metastatic breast cancer (MBC). Eligible patients will have an initial metastatic breast cancer d iagnosis that has not been previously treated with systemic therapy; patients ma y be enrolled up to 6 months after the diagnosis. Data will be collected for up to 8 years.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Cohort Study Of Treatment Patterns And Outcomes In Patients With HER2 Positive (Her2+) Metastatic Breast Cancer (SystHERs Registry (Systematic Therapies for HER2+ Metastatic Breast Cancer Study)).

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Distribution of patients receiving unique treatment regimen/sequence of treatment regimens [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
  • Post-progression survival (PPS) [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
  • Time-to-treatment failure (TTF) [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
  • Response rate (RR) [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
  • Patient-reported outcome assessment (PRO) [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Tissue and whole blood samples


Estimated Enrollment: 1000
Study Start Date: June 2012
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with HER2 positive (HER2+) metastatic breast cancer

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01615068

Contacts
Contact: Reference Study ID Number: ML28257 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Hide Study Locations
Locations
United States, Alabama
Recruiting
Birmingham, Alabama, United States, 35205
Recruiting
Mobile, Alabama, United States, 36604
United States, Arizona
Recruiting
Sedona, Arizona, United States, 86336
Recruiting
Tucson, Arizona, United States, 85704
United States, Arkansas
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Hot Springs, Arkansas, United States, 71913
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Jonesboro, Arkansas, United States, 72401
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Little Rock, Arkansas, United States, 72205
Recruiting
Rogers, Arkansas, United States, 72758
United States, California
Recruiting
Burbank, California, United States, 91505
Completed
Campbell, California, United States, 95008
Recruiting
Encinitas, California, United States, 92008
Recruiting
Fountain Valley, California, United States, 92708-7510
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Fresno, California, United States, 93720
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Fresno, California, United States, 93710
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Fullerton, California, United States, 92835
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Los Angeles, California, United States, 90033
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Los Angeles, California, United States, 90095
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Palm Springs, California, United States, 92262
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San Francisco, California, United States, 94115
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San Luis Obispo, California, United States, 93401
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San Luis Obispo, California, United States, 93454
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Santa Rosa, California, United States, 95403
United States, Colorado
Recruiting
Denver, Colorado, United States, 80220
Recruiting
Denver, Colorado, United States, 80205
Recruiting
Denver, Colorado, United States, 80210
United States, Connecticut
Recruiting
Bridgeport, Connecticut, United States, 06610
Recruiting
Middletown, Connecticut, United States, 06457
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New Haven, Connecticut, United States, 06520
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Stamford, Connecticut, United States, 06902
United States, District of Columbia
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Washington, District of Columbia, United States, 20010
United States, Florida
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Boca Raton, Florida, United States, 33428
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Deerfield Beach, Florida, United States, 33442
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Fort Myers, Florida, United States, 33908
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Hollywood, Florida, United States, 33021
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Jacksonville, Florida, United States, 32207
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Jacksonville, Florida, United States, 32256
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Lakeland, Florida, United States, 33804-1057
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Orlando, Florida, United States, 32806
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Plantation, Florida, United States, 33324
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Saint Petersburg, Florida, United States, 33705
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Titusville, Florida, United States, 32795
United States, Georgia
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Atlanta, Georgia, United States, 30318
Recruiting
Marietta, Georgia, United States, 30060
Recruiting
Savannah, Georgia, United States, 31405
United States, Idaho
Recruiting
Post Falls, Idaho, United States, 83854
United States, Illinois
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Alton, Illinois, United States, 62002
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Chicago, Illinois, United States, 60612
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Normal, Illinois, United States, 61761
Recruiting
Park Ridge, Illinois, United States, 60068
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Skokie, Illinois, United States, 60076
Recruiting
Urbana, Illinois, United States, 61801
United States, Indiana
Recruiting
Evansville, Indiana, United States, 47714
United States, Iowa
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Ames, Iowa, United States, 50010
Recruiting
Iowa City, Iowa, United States, 52242
Recruiting
Mason City, Iowa, United States, 50401
United States, Kansas
Recruiting
Wichita, Kansas, United States, 67214-3728
United States, Kentucky
Recruiting
Louisville, Kentucky, United States, 40202
Recruiting
Louisville, Kentucky, United States, 40207
United States, Louisiana
Recruiting
Baton Rouge, Louisiana, United States, 70809
Not yet recruiting
Lafayette, Louisiana, United States, 70503-2616
United States, Maine
Recruiting
Portland, Maine, United States, 04102
United States, Maryland
Recruiting
Cumberland, Maryland, United States, 21502
Recruiting
Rockville, Maryland, United States, 20850
Recruiting
Silver Spring, Maryland, United States, 20902
Not yet recruiting
Towson, Maryland, United States, 21204
Recruiting
Westminster, Maryland, United States, 21157
United States, Michigan
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Grand Rapids, Michigan, United States, 49503
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Kalamazoo, Michigan, United States, 49007
United States, Minnesota
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Edina, Minnesota, United States, 55435
Recruiting
Minneapolis, Minnesota, United States, 55407
Recruiting
St Louis Park, Minnesota, United States, 55416
United States, Mississippi
Recruiting
Jackson, Mississippi, United States, 39202
United States, Missouri
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Jefferson City, Missouri, United States, 65109
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Kansas City, Missouri, United States, 64132
Recruiting
St Louis, Missouri, United States, 63136
Recruiting
St Louis, Missouri, United States, 63141
United States, Montana
Recruiting
Billings, Montana, United States, 59101
Recruiting
Missoula, Montana, United States, 59802
United States, Nebraska
Recruiting
Lincoln, Nebraska, United States, 68510
Recruiting
Omaha, Nebraska, United States, 68106
United States, Nevada
Recruiting
Las Vegas, Nevada, United States, 89148
United States, New Hampshire
Recruiting
Lebanon, New Hampshire, United States, 03756
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Portsmouth, New Hampshire, United States, 03801
United States, New Jersey
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Berkeley Heights, New Jersey, United States, 07922
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Denville, New Jersey, United States, 07834
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Hackensack, New Jersey, United States, 07601
Recruiting
Morristown, New Jersey, United States, 07960
Recruiting
Paramus, New Jersey, United States, 07652
United States, New York
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Cooperstown, New York, United States, 13326
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East Setauket, New York, United States, 11733
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Jamaica, New York, United States, 11432
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New York, New York, United States, 10011
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New York, New York, United States, 10032
United States, North Carolina
Recruiting
Asheville, North Carolina, United States, 28806
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Gastonia, North Carolina, United States, 28054
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Greensboro, North Carolina, United States, 27403
Recruiting
Lumberton, North Carolina, United States, 28358
Recruiting
Pinehurst, North Carolina, United States, 28374
United States, Ohio
Recruiting
Cleveland, Ohio, United States, 44109
Recruiting
Columbus, Ohio, United States, 43219
Recruiting
Middletown, Ohio, United States, 45042
Recruiting
Sylvania, Ohio, United States, 43560
United States, Oklahoma
Recruiting
Oklahoma City, Oklahoma, United States, 73120
Recruiting
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Recruiting
Dunmore, Pennsylvania, United States, 18512
Recruiting
Lancaster, Pennsylvania, United States, 17605
Recruiting
Philadelphia, Pennsylvania, United States, 19140
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Pittsburgh, Pennsylvania, United States, 15212
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Pittsburgh, Pennsylvania, United States, 15213
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Sayre, Pennsylvania, United States, 18840
United States, South Carolina
Recruiting
Charleston, South Carolina, United States, 29414
Recruiting
Charleston, South Carolina, United States, 29425
Recruiting
Columbia, South Carolina, United States, 29210
United States, Tennessee
Recruiting
Chattanooga, Tennessee, United States, 37404
Recruiting
Kingsport, Tennessee, United States, 37660
Recruiting
Knoxville, Tennessee, United States, 37909
Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Recruiting
Abilene, Texas, United States, 79601-2301
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Bedford, Texas, United States, 76022
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Bryan, Texas, United States, 77802
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Dallas, Texas, United States, 75246
Recruiting
El Paso, Texas, United States, 79915
Not yet recruiting
El Paso, Texas, United States, 79915
Recruiting
Fort Worth, Texas, United States, 76104
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Houston, Texas, United States, 77024
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McAllen, Texas, United States, 78503
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Paris, Texas, United States, 75460
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Tyler, Texas, United States, 75701
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Waco, Texas, United States, 76712
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Webster, Texas, United States, 77598-4420
United States, Utah
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Ogden, Utah, United States, 84403
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Salt Lake City, Utah, United States, 84112
United States, Virginia
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Lynchburg, Virginia, United States, 24501
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Newport News, Virginia, United States, 23601
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Richmond, Virginia, United States, 23230
Recruiting
Winchester, Virginia, United States, 22601
United States, Washington
Recruiting
Seattle, Washington, United States, 98101
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Spokane, Washington, United States, 99204
United States, West Virginia
Recruiting
Morgantown, West Virginia, United States, 26506-9162
United States, Wisconsin
Recruiting
Madison, Wisconsin, United States, 53705
Recruiting
Milwaukee, Wisconsin, United States, 53211
India
Recruiting
Pittsfeild, India, 500029
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

No publications provided by Genentech, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01615068     History of Changes
Other Study ID Numbers: ML28257
Study First Received: June 6, 2012
Last Updated: November 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 24, 2014