A Study of Patients With HER2-Positive Metastatic Breast Cancer

NCT ID: NCT00105456

Last Updated: 2010-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-03-31

Study Completion Date

2009-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Genentech, Inc.

Principal Investigators

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Isaiah Dimery, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

References

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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.

Reference Type DERIVED
PMID: 24743708 (View on PubMed)

Other Identifiers

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H2757n

Identifier Type: -

Identifier Source: org_study_id

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