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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01615068
First received: June 6, 2012
Last updated: August 1, 2016
Last verified: August 2016
  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:


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

Enrollment: 1017
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   (Adult, Senior)
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

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35205
Mobile, Alabama, United States, 36604
United States, Arizona
Sedona, Arizona, United States, 86336
Tucson, Arizona, United States, 85704
United States, Arkansas
Hot Springs, Arkansas, United States, 71913
Jonesboro, Arkansas, United States, 72401
Little Rock, Arkansas, United States, 72205
Rogers, Arkansas, United States, 72758
United States, California
Burbank, California, United States, 91505
Campbell, California, United States, 95008
Encinitas, California, United States, 92008
Fountain Valley, California, United States, 92708-7510
Fresno, California, United States, 93710
Fresno, California, United States, 93720
Fullerton, California, United States, 92835
Los Angeles, California, United States, 90033
Los Angeles, California, United States, 90095
Palm Springs, California, United States, 92262
San Francisco, California, United States, 94115
San Luis Obispo, California, United States, 93401
San Luis Obispo, California, United States, 93454
Santa Rosa, California, United States, 95403
United States, Colorado
Denver, Colorado, United States, 80205
Denver, Colorado, United States, 80220
Littleton, Colorado, United States, 80122
United States, Connecticut
Middletown, Connecticut, United States, 06457
New Haven, Connecticut, United States, 06520
Stamford, Connecticut, United States, 06902
United States, District of Columbia
Washington, District of Columbia, United States, 20010
United States, Florida
Boca Raton, Florida, United States, 33428
Deerfield Beach, Florida, United States, 33442
Fort Myers, Florida, United States, 33908
Hollywood, Florida, United States, 33021
Jacksonville, Florida, United States, 32207
Jacksonville, Florida, United States, 32256
Lakeland, Florida, United States, 33804-1057
Orlando, Florida, United States, 32806
Plantation, Florida, United States, 33324
Saint Petersburg, Florida, United States, 33705
Titusville, Florida, United States, 32795
United States, Georgia
Atlanta, Georgia, United States, 30318
Marietta, Georgia, United States, 30060
Savannah, Georgia, United States, 31405
United States, Idaho
Post Falls, Idaho, United States, 83854
United States, Illinois
Alton, Illinois, United States, 62002
Chicago, Illinois, United States, 60612
Normal, Illinois, United States, 61761
Park Ridge, Illinois, United States, 60068
Skokie, Illinois, United States, 60076
Urbana, Illinois, United States, 61801
United States, Indiana
Evansville, Indiana, United States, 47714
United States, Iowa
Ames, Iowa, United States, 50010
Iowa City, Iowa, United States, 52242
Mason City, Iowa, United States, 50401
United States, Kansas
Wichita, Kansas, United States, 67214-3728
United States, Kentucky
Louisville, Kentucky, United States, 40202
Louisville, Kentucky, United States, 40207
United States, Louisiana
Baton Rouge, Louisiana, United States, 70809
Lafayette, Louisiana, United States, 70503-2616
United States, Maine
Portland, Maine, United States, 04102
United States, Maryland
Cumberland, Maryland, United States, 21502
Rockville, Maryland, United States, 20850
Silver Spring, Maryland, United States, 20902
Towson, Maryland, United States, 21204
Westminster, Maryland, United States, 21157
United States, Massachusetts
Pittsfeild, Massachusetts, United States, 01201
United States, Michigan
Grand Rapids, Michigan, United States, 49503
Kalamazoo, Michigan, United States, 49007
United States, Minnesota
Edina, Minnesota, United States, 55435
Minneapolis, Minnesota, United States, 55407
St Louis Park, Minnesota, United States, 55416
United States, Mississippi
Jackson, Mississippi, United States, 39202
United States, Missouri
Jefferson City, Missouri, United States, 65109
Kansas City, Missouri, United States, 64132
St Louis, Missouri, United States, 63136
St Louis, Missouri, United States, 63141
United States, Montana
Billings, Montana, United States, 59101
Missoula, Montana, United States, 59802
United States, Nebraska
Lincoln, Nebraska, United States, 68510
Omaha, Nebraska, United States, 68106
United States, Nevada
Las Vegas, Nevada, United States, 89148
United States, New Hampshire
Lebanon, New Hampshire, United States, 03756
Portsmouth, New Hampshire, United States, 03801
United States, New Jersey
Berkeley Heights, New Jersey, United States, 07922
Denville, New Jersey, United States, 07834
Hackensack, New Jersey, United States, 07601
Morristown, New Jersey, United States, 07960
Paramus, New Jersey, United States, 07652
United States, New York
Cooperstown, New York, United States, 13326
East Setauket, New York, United States, 11733
Jamaica, New York, United States, 11432
New York, New York, United States, 10011
New York, New York, United States, 10032
United States, North Carolina
Asheville, North Carolina, United States, 28806
Gastonia, North Carolina, United States, 28054
Greensboro, North Carolina, United States, 27403
Lumberton, North Carolina, United States, 28358
Pinehurst, North Carolina, United States, 28374
United States, Ohio
Cleveland, Ohio, United States, 44109
Columbus, Ohio, United States, 43219
Middletown, Ohio, United States, 45042
Sylvania, Ohio, United States, 43560
United States, Oklahoma
Ohlahoma CIty, Oklahoma, United States, 73120
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Portland, Oregon, United States, 97231
United States, Pennsylvania
Dunmore, Pennsylvania, United States, 18512
Lancaster, Pennsylvania, United States, 17605
Philadelphia, Pennsylvania, United States, 19140
Pittsburgh, Pennsylvania, United States, 15212
Pittsburgh, Pennsylvania, United States, 15213
Sayre, Pennsylvania, United States, 18840
United States, South Carolina
Charleston, South Carolina, United States, 29414
Charleston, South Carolina, United States, 29425
Columbia, South Carolina, United States, 29210
United States, Tennessee
Chattanooga, Tennessee, United States, 37404
Kingsport, Tennessee, United States, 37660
Knoxville, Tennessee, United States, 37909
Nashville, Tennessee, United States, 37203
United States, Texas
Abilene, Texas, United States, 79601-2301
Bedford, Texas, United States, 76022
Bryan, Texas, United States, 77802
Dallas, Texas, United States, 75246
El Paso, Texas, United States, 79915
Fort Worth, Texas, United States, 76104
Houston, Texas, United States, 77024
McAllen, Texas, United States, 78503
Paris, Texas, United States, 75460
Tyler, Texas, United States, 75701
Waco, Texas, United States, 76712
Webster, Texas, United States, 77598-4420
United States, Utah
Ogden, Utah, United States, 84403
Salt Lake City, Utah, United States, 84112
United States, Virginia
Lynchburg, Virginia, United States, 24501
Newport News, Virginia, United States, 23601
Richmond, Virginia, United States, 23226
Winchester, Virginia, United States, 22601
United States, Washington
Seattle, Washington, United States, 98101
United States, West Virginia
Morgantown, West Virginia, United States, 26506-9162
United States, Wisconsin
Madison, Wisconsin, United States, 53705
Milwaukee, Wisconsin, United States, 53211
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

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: August 1, 2016
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 August 30, 2016