Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-02-22 @ 9:39 AM
Study NCT ID:
NCT02625935
Status:
COMPLETED
Last Update Posted:
2017-10-13
First Post:
2015-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Observational Study Evaluating Treatment Decision Impact of Prosigna® in Early Stage Breast Cancer Patients
Sponsor:
NanoString Technologies, Inc.
Organization:
Study Overview
Official Title:
A Prospective Observational Study Evaluating Treatment Decision Impact of Prosigna® in Early Stage Breast Cancer Patients Who Are Candidates for Genomic Testing
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: