An Observational Study in Patients With HER2 Positive Metastatic Breast Cancer (SystHERs Registry)

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Basic Trial Information

PhaseTypeAgeTrial IDs
No phase specifiedNatural history/Epidemiology18 and overML28257
NCI-2014-00984, NCT01615068

Trial Description

Summary

This multi-center, prospective observational study will evaluate the treatment patterns, and

the safety in patients with HER2-positive (HER2+) metastatic breast cancer (MBC). Eligible

patients will have an initial metastatic breast cancer diagnosis that has not been

previously treated with systemic therapy; patients may be enrolled up to 6 months after the

diagnosis. Data will be collected for up to 8 years.

Eligibility Criteria

Inclusion Criteria:

Availability of cancer-specific historical data points in the patient's medical

records

Initial diagnosis of HER2+ MBC, as diagnosed by the treating physician, no more than

6 months prior to study enrollment

Adult patients, >/=18 years of age

Exclusion Criteria:

Any inability to provide informed consent

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Genentech Inc.

    Trial Sites

    U.S.A.

    California
    Los Angeles

    UCLA / Jonsson Comprehensive Cancer Center

    Sara Alsterlind Hurvitz
    Principal Investigator

    USC / Norris Comprehensive Cancer Center

    Darcy Vernon Spicer
    Principal Investigator

    South Carolina
    Charleston

    Medical University of South Carolina

    Neal Paul Christiansen
    Principal Investigator

    Link to the current ClinicalTrials.gov record.
    NLM Identifer NCT01615068

    Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.