Breast Cancer Clinical Trial
Official title:
registHER: An Observational Cohort Study of Patients With HER2 Positive Metastatic Breast Cancer
| Verified date | May 2010 |
| Source | Genentech, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1000 |
| Est. completion date | May 2009 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Genentech, Inc. |
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