This study investigates how the results of the Prosigna test affects physicians' clinical decision-making regarding treatment before surgery in patients with hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) breast cancer that is early-stage or spread from its original site of growth to nearby tissues or lymph nodes (locally advanced). Prosigna assay results may help doctors make decisions about patients' treatment before surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03749421.
PRIMARY OBJECTIVE:
I. To assess the extent to which the Prosigna test results will change physician’s pretest decision regarding neoadjuvant treatment of patients with stage II-III ER/progesterone receptor (PR) +, HER2-negative breast cancer.
SECONDARY OBJECTIVES:
I. To estimate the association of pathologic complete response (pCR)/residual cancer burden (RCB) following neoadjuvant therapy with risk of recurrence (ROR).
II. To assess if the treatment change was based on ROR score, intrinsic subtype or both.
III. To evaluate physicians’ confidence in their therapy before and after the test.
IV. To evaluate patients’ confidence in their therapy before and after the test.
OUTLINE:
Previously collected core biopsy tissue samples are analyzed via Prosigna assay, and the results are presented to the physicians and patients for discussion. Physicians' decisions on neoadjuvant treatment are recorded before after Prosigna assay.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorSara Michell Tolaney
