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Trial record 1 of 1 for:    NCT01615068
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An Observational Study in Patients With HER2 Positive Metastatic Breast Cancer (SystHERs Registry)

This study is currently recruiting participants.
Verified May 2013 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01615068
First received: June 6, 2012
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


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:

U.S. FDA Resources

Further study details as provided by Genentech:

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

Contacts
Contact: Please reference Study ID Number: ML28257 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

  Hide Study Locations
Locations
United States, Alabama
Recruiting
Birmingham, Alabama, United States, 35205
United States, Arkansas
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Hot Springs, Arkansas, United States, 71913
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Jonesboro, Arkansas, United States, 72401
United States, California
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Burbank, California, United States, 91505
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Campbell, California, United States, 95008
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Fresno, California, United States, 93720
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Los Angeles, California, United States, 90033
Not yet recruiting
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
United States, Colorado
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Denver, Colorado, United States, 80210
United States, Connecticut
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Bridgeport, Connecticut, United States, 06610
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Middletown, Connecticut, United States, 06457
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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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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, 32256
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Jacksonville, Florida, United States, 32207
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Lakeland, Florida, United States, 33805
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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, 30309
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Marietta, Georgia, United States, 30060
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Savannah, Georgia, United States, 31405
United States, Illinois
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Alton, Illinois, United States, 62002
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Normal, Illinois, United States, 61761
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Park Ridge, Illinois, United States, 60068
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Skokie, Illinois, United States, 60076
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Urbana, Illinois, United States, 61801
United States, Indiana
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Evansville, Indiana, United States, 47714
United States, Iowa
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Ames, Iowa, United States, 50010
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Iowa City, Iowa, United States, 52242
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Mason City, Iowa, United States, 50401
United States, Kansas
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Wichita, Kansas, United States, 67214
United States, Kentucky
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Louisville, Kentucky, United States, 40207
Not yet recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
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Baton Rouge, Louisiana, United States, 70809
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Baton Rouge, Louisiana, United States, 70809
United States, Maine
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Portland, Maine, United States, 04102
United States, Maryland
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Cumberland, Maryland, United States, 21502
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Rockville, Maryland, United States, 20850-3348
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Silver Spring, Maryland, United States, 20902
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Westminster, Maryland, United States, 21157
United States, Michigan
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Grand Rapids, Michigan, United States, 49546
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Kalamazoo, Michigan, United States, 49007
United States, Minnesota
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Edina, Minnesota, United States, 55435
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St Louis Park, Minnesota, United States, 55416
United States, Missouri
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Jefferson City, Missouri, United States, 65109
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St Louis, Missouri, United States, 63141
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St Louis, Missouri, United States, 63136
United States, Montana
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Billings, Montana, United States, 59101
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Missoula, Montana, United States, 59802
United States, Nebraska
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Lincoln, Nebraska, United States, 68510
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Omaha, Nebraska, United States, 68106
United States, New Hampshire
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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
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Morristown, New Jersey, United States, 07960
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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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New York, New York, United States, 10011
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New York, New York, United States, 10032
United States, North Carolina
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Gastonia, North Carolina, United States, 28054
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Greensboro, North Carolina, United States, 27403
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Pinehurst, North Carolina, United States, 28374
United States, Ohio
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Cleveland, Ohio, United States, 44109
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Columbus, Ohio, United States, 43219
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Middletown, Ohio, United States, 45042
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Sylvania, Ohio, United States, 43560
United States, Oklahoma
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Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
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Dunmore, Pennsylvania, United States, 18512
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Lancaster, Pennsylvania, United States, 17605
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Philadelphia, Pennsylvania, United States, 19140
Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15212
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Sayre, Pennsylvania, United States, 18840
United States, South Carolina
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Charleston, South Carolina, United States, 29403-5740
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Charleston, South Carolina, United States, 29425
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Columbia, South Carolina, United States, 29210
United States, Tennessee
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Chattanooga, Tennessee, United States, 37404
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Kingsport, Tennessee, United States, 37660
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Knoxville, Tennessee, United States, 37909
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Nashville, Tennessee, United States, 37203
United States, Texas
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Abilene, Texas, United States, 79601-2301
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Bryan, Texas, United States, 77802
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Tyler, Texas, United States, 75701
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
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Winchester, Virginia, United States, 22601
United States, West Virginia
Recruiting
Morgantown, West Virginia, United States, 26506-9162
United States, Wisconsin
Not yet recruiting
Milwaukee, Wisconsin, United States, 53211
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01615068     History of Changes
Other Study ID Numbers: ML28257
Study First Received: June 6, 2012
Last Updated: May 6, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013