Ignite Creation Date:
2024-05-06 @ 1:45 AM
Last Modification Date:
2024-10-26 @ 11:09 AM
Study NCT ID:
NCT01899079
Status:
COMPLETED
Last Update Posted:
2015-03-19
First Post:
2013-07-10
Brief Title:
A Prospective Observational Study of Clinical Outcomes for the NanoString Technologies Prosigna Gene Signature Assay
Sponsor:
NanoString Technologies Inc
Organization:
NanoString Technologies Inc
Study Overview
Official Title:
Prospective Observational Study to Evaluate the Impact of the Determination of the Intrinsic Subtypes of Breast Cancer by PAM50 NanoString Technology in the Use of Adjuvant Chemotherapy in Women With Breast Cancer HR and Node -
Status:
COMPLETED
Status Verified Date:
2015-03
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:
The primary objective of this study is to assess the extent to which the Prosigna Breast Cancer Prognostic Gene Signature Assay affects the medical oncologists treatment recommendations regarding adjuvant chemotherapy and actual treatments received for patients with early-stage breast cancer
Detailed Description:
Changes in treatment recommendations will include 1 hormonal therapy alone 2 hormonal therapy plus chemotherapy and 3 changes in types of chemotherapy if chemotherapy was recommended before and after the Prosigna test
Study Oversight
Has Oversight DMC:
None
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?:
None