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).
| Original language | English |
|---|---|
| Article number | 307 |
| Journal | BMC Cancer |
| Volume | 14 |
| Issue number | 1 |
| DOIs | |
| State | Published - May 2 2014 |
| Externally published | Yes |
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Keywords
- Ado-trastuzumab emtansine
- HER2
- Human epidermal growth factor receptor 2
- Metastatic breast cancer
- Observational cohort study
- Patient-reported outcome
- Pertuzumab
- Registry
- SystHERs
- Trastuzumab
- Trastuzumab emtansine
ASJC Scopus subject areas
- Oncology
- Cancer Research
- Genetics
Cite this
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. / Tripathy, Debu; Rugo, Hope S.; Kaufman, Peter A.; Swain, Sandra; O'Shaughnessy, Joyce; Jahanzeb, Mohammad; Mason, Ginny; Beattie, Mary; Yoo, Bongin; Lai, Catherine; Masaquel, Anthony; Hurvitz, Sara.
In: BMC Cancer, Vol. 14, No. 1, 307, 02.05.2014.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - The SystHERs registry
T2 - An observational cohort study of treatment patterns and outcomes in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer
AU - Tripathy, Debu
AU - Rugo, Hope S.
AU - Kaufman, Peter A.
AU - Swain, Sandra
AU - O'Shaughnessy, Joyce
AU - Jahanzeb, Mohammad
AU - Mason, Ginny
AU - Beattie, Mary
AU - Yoo, Bongin
AU - Lai, Catherine
AU - Masaquel, Anthony
AU - Hurvitz, Sara
PY - 2014/5/2
Y1 - 2014/5/2
N2 - 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).
AB - 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).
KW - Ado-trastuzumab emtansine
KW - HER2
KW - Human epidermal growth factor receptor 2
KW - Metastatic breast cancer
KW - Observational cohort study
KW - Patient-reported outcome
KW - Pertuzumab
KW - Registry
KW - SystHERs
KW - Trastuzumab
KW - Trastuzumab emtansine
UR - http://www.scopus.com/inward/record.url?scp=84899932145&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84899932145&partnerID=8YFLogxK
U2 - 10.1186/1471-2407-14-307
DO - 10.1186/1471-2407-14-307
M3 - Article
C2 - 24885258
AN - SCOPUS:84899932145
VL - 14
JO - BMC Cancer
JF - BMC Cancer
SN - 1471-2407
IS - 1
M1 - 307
ER -