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Open Access Study protocol

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

Debu Tripathy1*, Hope S Rugo2, Peter A Kaufman3, Sandra Swain4, Joyce O’Shaughnessy5, Mohammad Jahanzeb6, Ginny Mason7, Mary Beattie8, Bongin Yoo8, Catherine Lai8, Anthony Masaquel8 and Sara Hurvitz9

Author Affiliations

1 Keck School of Medicine, University of Southern California, USC Norris Comprehensive Cancer Center, Los Angeles, CA, USA

2 University of California San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA

3 Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center, Lebanon NH, USA

4 Washington Cancer Institute, Medstar Washington Hospital Center, Washington, DC, USA

5 Charles A. Sammons Cancer Center, Texas Oncology, The US Oncology Network, Dallas, TX, USA

6 University of Miami Sylvester Comprehensive Cancer Center Deerfield Campus, Deerfield Beach, FL, USA

7 Inflammatory Breast Cancer Research Foundation, West Lafayette, IN, USA

8 Genentech, Inc, South San Francisco, CA, USA

9 University of California at Los Angeles Jonsson Comprehensive Cancer Center, Los Angeles, CA, USA

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BMC Cancer 2014, 14:307  doi:10.1186/1471-2407-14-307

Published: 2 May 2014

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).

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.

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.

Trial registration number

NCT01615068 (ClinicalTrials.gov identifier).

Keywords:
Ado-trastuzumab emtansine; Human epidermal growth factor receptor 2; HER2; Metastatic breast cancer; Observational cohort study; Patient-reported outcome; Pertuzumab; Registry; SystHERs; Trastuzumab; Trastuzumab emtansine