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A Study of Patients With HER2-Positive Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00105456
First received: March 14, 2005
Last updated: May 4, 2010
Last verified: May 2010
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Genentech:

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00105456

Sponsors and Collaborators
Genentech
Investigators
Study Director: Isaiah Dimery, M.D. Genentech
  More Information

No publications provided

Responsible Party: Clinical Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00105456     History of Changes
Other Study ID Numbers: H2757n
Study First Received: March 14, 2005
Last Updated: May 4, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Genentech:
HER2-Positive Metastatic Breast Cancer
HER2

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

ClinicalTrials.gov processed this record on May 16, 2013