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

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
No phase specifiedNatural history/EpidemiologyActive18 and overML28257
NCI-2014-00984, NCT01615068

Trial Description


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:

Adult patients, >/=18 years of age

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

6 months prior to study enrollment

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


Exclusion Criteria:

Any inability to provide informed consent

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Genentech Inc.

    Trial Sites


    Los Angeles

    UCLA / Jonsson Comprehensive Cancer Center

    Sara Alsterlind Hurvitz
    Principal Investigator

    USC / Norris Comprehensive Cancer Center

    Darcy Vernon Spicer
    Principal Investigator

    South Carolina

    Medical University of South Carolina

    Neal Paul Christiansen
    Principal Investigator

    Link to the current record.
    NLM Identifier NCT01615068

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