Ignite Creation Date:
2024-05-06 @ 3:19 AM
Last Modification Date:
2024-10-26 @ 11:32 AM
Study NCT ID:
NCT02269813
Status:
COMPLETED
Last Update Posted:
2019-08-13
First Post:
2014-10-14
Brief Title:
PRospective Study to Measure the Impact of MammaPrint on Adjuvant Treatment in Hormone Receptor-positive HER2-negative Breast Cancer Patients PRIMe
Sponsor:
West German Study Group
Organization:
West German Study Group
Study Overview
Official Title:
PRospective Study to Measure the Impact of MammaPrint on Adjuvant Treatment in Hormone Receptor-positive HER2-negative Breast Cancer Patients PRIMe
Status:
COMPLETED
Status Verified Date:
2019-08
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:
PRIMe
Brief Summary:
PRIMe is a prospective case-only trial designed to measure the impact of MammaPrint on physician chemotherapy intention in the two discordant groups ETPOOR CTGOOD in stage 1 and 2 HR-positive HER2-negative breast cancer patients The design also provides for assessment of several important secondary indicators Eligible patients will have their tumor sample analyzed for MammaPrint BluePrint and TargetPrint Patients cannot start treatment before the MammaPrint result is received and taken into consideration for the adjuvant treatment plan
Detailed Description:
None
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