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

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedNatural history/EpidemiologyActive18 and overPharmaceutical / IndustryML28257
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:

  • 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 records

Exclusion Criteria:

  • Any inability to provide informed consent

Trial Contact Information

Trial Lead Organizations/Sponsors

Genentech Incorporated

    Clinical Trials, Study Director
    Reference Study ID Number: ML28257 www.roche.com/about_roche/roche_worldwide.htm
    Ph: 888-662-6728 (U.S. Only)
    Email: global.rochegenentechtrials@roche.com

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT01615068
    ClinicalTrials.gov processed this data on May 21, 2015

    Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.