An Observational Study in Patients With HER2 Positive Metastatic Breast Cancer (SystHERs Registry)
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ClinicalTrials.gov Identifier: NCT01615068 |
Recruitment Status
:
Completed
First Posted
: June 8, 2012
Last Update Posted
: January 10, 2018
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Sponsor:
Genentech, Inc.
Information provided by (Responsible Party):
Genentech, Inc.
Tracking Information | ||||
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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 |
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 |
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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 |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples With DNA Description: Tissue and whole blood samples |
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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. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
1007 | |||
Original Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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PRS Account | Genentech, Inc. | |||
Verification Date | January 2018 |