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A Study of Patients With HER2-Positive Metastatic Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00105456
First Posted: March 15, 2005
Last Update Posted: May 6, 2010
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.
Information provided by:
Genentech, Inc.
  Purpose
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 Phase
Breast Cancer Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: registHER: An Observational Cohort Study of Patients With HER2 Positive Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Estimated Enrollment: 1000
Study Start Date: March 2003
Study Completion Date: May 2009
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.
Criteria

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
  Contacts and Locations
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.
Investigators
Study Director: Isaiah Dimery, M.D. Genentech, Inc.
  More Information

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 Submitted: March 14, 2005
First Posted: March 15, 2005
Last Update Posted: May 6, 2010
Last Verified: May 2010

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

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