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CompletedNCT00105456Updated May 6, 2010

A Study of Patients With HER2-Positive Metastatic Breast Cancer

An observational study in Breast Cancer, sponsored by Genentech, Inc.. Completed. Per ClinicalTrials.gov, last updated 2010-05-06.

Sponsored by Genentech, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Sex
All
01

Study 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.

02

Conditions studied

  • Breast Cancer

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Keywords

  • HER2-Positive Metastatic Breast Cancer
  • HER2
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 1,000 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

Exclusion Criteria:

  • There are no exclusion criteria for participation in this trial
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants
06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 24743708 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00105456
Lead sponsor
Genentech, Inc.
First posted
Mar 15, 2005
Start date
Mar 2003
Completion
May 2009
Last update
May 6, 2010

Study contacts

Isaiah Dimery, M.D.
study director · Genentech, Inc.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.

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Discussion

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