A Study of Patients With HER2-Positive Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.

First Received: March 14, 2005 Last Updated: March 9, 2006 History of Changes

Sponsored by:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00105456

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 IV

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Defined Population, Prospective Study
Official Title:	registHER: An Observational Cohort Study of Patients With HER2 Positive Metastatic Breast Cancer

Further study details as provided by Genentech:

Estimated Enrollment:	1000
Study Start Date:	March 2003
Estimated Study Completion Date:	December 2009

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Locations

United States, California
Genentech Central Contact
South San Francisco, California, United States, 94080

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Isela Dimery, M.D.

Genentech

More Information

No publications provided

Study ID Numbers:	H2757n
Study First Received:	March 14, 2005
Last Updated:	March 9, 2006
ClinicalTrials.gov Identifier:	NCT00105456 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Genentech:

HER2-Positive Metastatic Breast Cancer
HER2

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009