NCT00105456

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2003

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2005

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

May 6, 2010

Status Verified

May 1, 2010

First QC Date

March 14, 2005

Last Update Submit

May 4, 2010

Conditions

Breast Cancer

Keywords

HER2-Positive Metastatic Breast CancerHER2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from managed care organizations, community physicians or practices, and academic centers.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Yardley DA, Tripathy D, Brufsky AM, Rugo HS, Kaufman PA, Mayer M, Magidson J, Yoo B, Quah C, Ulcickas Yood M. Long-term survivor characteristics in HER2-positive metastatic breast cancer from registHER. Br J Cancer. 2014 May 27;110(11):2756-64. doi: 10.1038/bjc.2014.174. Epub 2014 Apr 17.

    PMID: 24743708DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Isaiah Dimery, M.D.

    Genentech, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 14, 2005

First Posted

March 15, 2005

Study Start

March 1, 2003

Study Completion

May 1, 2009

Last Updated

May 6, 2010

Record last verified: 2010-05