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. (Record no. 1571)

MARC details
000 -LEADER
fixed length control field 04170nam a22004937a 4500
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 150318s20142014 xxu||||| |||| 00| 0 eng d
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER
International Standard Serial Number 1471-2407
040 ## - CATALOGING SOURCE
Original cataloging agency Ovid MEDLINE(R)
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC)
PMID 24885258
245 ## - TITLE STATEMENT
Title 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.
251 ## - Source
Source BMC Cancer. 14:307, 2014.
252 ## - Abbreviated Source
Abbreviated source BMC Cancer. 14:307, 2014.
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Year 2014
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Manufacturer FY2015
266 ## - Date added to catalog
Date added to catalog 2015-03-18
501 ## - WITH NOTE
Local holdings Available online from MWHC library: 2001 - present
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Abstract BACKGROUND: Amplification of the human epidermal growth factor receptor 2 (HER2) gene occurs in approximately 20% of invasive breast cancer cases and is associated with a more aggressive disease course than HER2-negative breast cancer. HER2-targeted therapies have altered the natural history of HER2-positive breast cancer, a trend that will likely further improve with the recent approval of new agents. A prospective, observational cohort study was designed and initiated to provide real-world insights into current treatment patterns, long-term survival, and patients' experiences with initial and subsequent treatments for HER2-positive metastatic breast cancer (MBC).
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Abstract DISCUSSION: SystHERs is expected to provide in-depth data on demographic, clinicopathological, and treatment patterns and their associations with clinical outcomes, PROs, and healthcare resource utilization. Tumor tissue and DNA repositories will also be established for use in future translational research.
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Abstract METHODS/DESIGN: The Systematic Therapies for HER2-positive Metastatic Breast Cancer Study (SystHERs) is a US-based prospective observational cohort study enrolling patients >18 years of age with recently diagnosed HER2-positive MBC not previously treated with systemic therapy in the metastatic setting. The primary objective of the study is to identify treatment patterns and clinical outcomes in recently diagnosed patients in a variety of practice settings. Secondary objectives include comparative efficacy, safety, and patient-reported outcomes (PROs). Healthcare resource utilization is an exploratory end point. Tumor tissue and blood sample collection is optional.The SystHERs registry will enroll approximately 1000 patients over a 3-year period, after which the study will continue for >5 years, allowing for a maximum follow-up of 8 years. The treating physician will determine all care and the frequency of visits. PRO measures will be completed at study enrollment and every 90 days. Clinical data will be abstracted quarterly from patient records. The first patient was enrolled in June 2012, and preliminary descriptive data based on 25% to 30% of the final study population are expected at the end of 2013, and as of April 25, 2014, 386 patients are enrolled.
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Abstract TRIAL REGISTRATION NUMBER: NCT01615068 (ClinicalTrials.gov identifier).
546 ## - LANGUAGE NOTE
Language note English
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Topical term or geographic name entry element *Antineoplastic Combined Chemotherapy Protocols/ad [Administration & Dosage]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Breast Neoplasms/dt [Drug Therapy]
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Topical term or geographic name entry element *Neoplasm Metastasis
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Topical term or geographic name entry element Antibodies, Monoclonal, Humanized/ad [Administration & Dosage]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Breast Neoplasms/ge [Genetics]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Breast Neoplasms/mo [Mortality]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Breast Neoplasms/pa [Pathology]
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Topical term or geographic name entry element Disease-Free Survival
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Topical term or geographic name entry element Female
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Topical term or geographic name entry element Humans
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Topical term or geographic name entry element Maytansine/aa [Analogs & Derivatives]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Maytansine/ad [Administration & Dosage]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Receptor, ErbB-2/ge [Genetics]
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Topical term or geographic name entry element Treatment Outcome
651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME
Institution Washington Cancer Institute
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Medline publication type Clinical Trial
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Medline publication type Journal Article
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Medline publication type Research Support, Non-U.S. Gov't
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Swain, Sandra M
790 ## - Authors
All authors Beattie M, Hurvitz S, Jahanzeb M, Kaufman PA, Lai C, Masaquel A, Mason G, O'Shaughnessy J, Rugo HS, Swain S, Tripathy D, Yoo B
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DOI <a href="http://dx.doi.org/10.1186/1471-2407-14-307">http://dx.doi.org/10.1186/1471-2407-14-307</a>
Public note http://dx.doi.org/10.1186/1471-2407-14-307
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Journal Article
Item type description Article
Holdings
Withdrawn status Lost status Damaged status Not for loan Collection Home library Current library Date acquired Total Checkouts Full call number Barcode Date last seen Date last checked out Price effective from Koha item type
          MedStar Authors Catalog MedStar Authors Catalog 03/18/2015 1 24885258 24885258 09/26/2017 09/26/2017 03/18/2015 Journal Article

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