This multicenter, prospectively designed study examines whether the Prosigna score influences physician and patient adjuvant treatment selection over and above currently used prognostic factors. This study also examines the impact of the test results on patients' reported outcomes, including their decisional conflict status and anxiety levels.
The primary objective of this study is to assess the extent to which the Prosigna test results affect the medical oncologist's treatment recommendations regarding adjuvant chemotherapy and actual treatments received for patients with early stage breast cancer conventionally considered candidates for genomic testing based on current treatment guidelines. The oncologist's initial recommendations will be based on the utilization of tools or algorithms based on clinical and pathologic factors. No genomic tools will be used in the initial assessment. Changes in recommendation after availability of Prosigna test results will include (1) hormonal therapy alone or (2) hormonal therapy plus chemotherapy, and (3) changes in types of chemotherapy if chemotherapy was recommended before and after the test.
Study Type
OBSERVATIONAL
Enrollment
206
Florida Cancer Center
Fort Myers, Florida, United States
New England Cancer Specialists
Scarborough, Maine, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
North Shore Hematology Oncology Assoaciates
East Setauket, New York, United States
The proportion of patients for whom the choice of treatment was changed as a result of receiving the Prosigna test results.
Time frame: 6 months
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