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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01615068
Recruitment Status : Completed
First Posted : June 8, 2012
Last Update Posted : January 10, 2018
Information provided by (Responsible Party):
Genentech, Inc.

June 6, 2012
June 8, 2012
January 10, 2018
June 5, 2012
November 16, 2017   (Final data collection date for primary outcome measure)
Distribution of patients receiving unique treatment regimen/sequence of treatment regimens [ Time Frame: Up to 8 years ]
Same as current
Complete list of historical versions of study NCT01615068 on Archive Site
  • Progression-free survival (PFS) [ Time Frame: Up to 8 years ]
  • Overall survival (OS) [ Time Frame: Up to 8 years ]
  • Post-progression survival (PPS) [ Time Frame: Up to 8 years ]
  • Time-to-treatment failure (TTF) [ Time Frame: Up to 8 years ]
  • Response rate (RR) [ Time Frame: Up to 8 years ]
  • Safety: Incidence of adverse events [ Time Frame: Up to 8 years ]
  • Patient-reported outcome assessment (PRO) [ Time Frame: Up to 8 years ]
Same as current
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An Observational Study in Patients With HER2 Positive Metastatic Breast Cancer (SystHERs Registry)
An Observational Cohort Study Of Treatment Patterns And Outcomes In Patients With HER2 Positive (Her2+) Metastatic Breast Cancer (SystHERs Registry (Systematic Therapies for HER2+ Metastatic Breast Cancer Study)).
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.
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Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Tissue and whole blood samples
Probability Sample
Patients with HER2 positive (HER2+) metastatic breast cancer
Breast Cancer
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Tripathy D, Rugo HS, Kaufman PA, Swain S, O'Shaughnessy J, Jahanzeb M, Mason G, Beattie M, Yoo B, Lai C, Masaquel A, Hurvitz S. The SystHERs registry: an observational cohort study of treatment patterns and outcomes in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer. BMC Cancer. 2014 May 2;14:307. doi: 10.1186/1471-2407-14-307.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 16, 2017
November 16, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
January 2018