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

Tracking Information
First Submitted Date	June 6, 2012
First Posted Date	June 8, 2012
Last Update Posted Date	January 10, 2018
Actual Study Start Date	June 5, 2012
Actual Primary Completion Date	November 16, 2017 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: June 7, 2012)	Distribution of patients receiving unique treatment regimen/sequence of treatment regimens [ Time Frame: Up to 8 years ]
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT01615068 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: June 7, 2012)	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 ]
Original Secondary Outcome Measures	Same as current
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	An Observational Study in Patients With HER2 Positive Metastatic Breast Cancer (SystHERs Registry)
Official Title	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)).
Brief 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.
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA; Description: Tissue and whole blood samples
Sampling Method	Probability Sample
Study Population	Patients with HER2 positive (HER2+) metastatic breast cancer
Condition	Breast Cancer
Intervention	Not Provided
Study Groups/Cohorts	Cohort
Publications *	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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: April 6, 2017)	1007
Original Estimated Enrollment; (submitted: June 7, 2012)	1000
Actual Study Completion Date	November 16, 2017
Actual Primary Completion Date	November 16, 2017 (Final data collection date for primary outcome measure)
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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries	India
Administrative Information
NCT Number	NCT01615068
Other Study ID Numbers	ML28257
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Genentech, Inc.
Study Sponsor	Genentech, Inc.
Collaborators	Not Provided
Investigators	Study Director: Clinical Trials Genentech, Inc.
PRS Account	Genentech, Inc.
Verification Date	January 2018