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A Study of Patients With HER2-Positive Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00105456
Recruitment Status : Completed
First Posted : March 15, 2005
Last Update Posted : May 6, 2010
Information provided by:
Genentech, Inc.

Brief Summary:
This is a prospective observational cohort study designed to describe effectiveness and safety (treatment outcomes and clinically significant cardiac adverse events, respectively) in patients with HER2-positive metastatic breast cancer.

Condition or disease Phase
Breast Cancer Phase 4

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: registHER: An Observational Cohort Study of Patients With HER2 Positive Metastatic Breast Cancer
Study Start Date : March 2003
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from managed care organizations, community physicians or practices, and academic centers.

Inclusion Criteria:

  • Signed Informed Consent document (unless the IRB has granted a waiver of consent)
  • Signed Authorization for the Use and Disclosure of Health Information document
  • HER2-positive breast cancer
  • Initial diagnosis of metastatic (Stage IV) breast cancer within 6 months prior to enrollment
  • Availability of cancer-specific historical data points in the patient's medical records

Exclusion Criteria:

  • There are no exclusion criteria for participation in this trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00105456

Sponsors and Collaborators
Genentech, Inc.
Study Director: Isaiah Dimery, M.D. Genentech, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Clinical Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00105456     History of Changes
Other Study ID Numbers: H2757n
First Posted: March 15, 2005    Key Record Dates
Last Update Posted: May 6, 2010
Last Verified: May 2010

Keywords provided by Genentech, Inc.:
HER2-Positive Metastatic Breast Cancer

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