Ignite Creation Date:
2024-05-06 @ 8:09 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02670577
Status:
COMPLETED
Last Update Posted:
2018-06-27
First Post:
2016-01-27
Brief Title:
Measuring the Impact of MammaPrint on Adjuvant and Neoadjuvant Treatment in Breast Cancer Patients A Prospective Registry
Sponsor:
Agendia
Organization:
Agendia
Study Overview
Official Title:
Measuring the Impact of MammaPrint on Adjuvant and Neoadjuvant Treatment in Breast Cancer Patients A Prospective Registry
Status:
COMPLETED
Status Verified Date:
2018-06
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:
IMPACt
Brief Summary:
The scope of this study is to measure the impact of MammaPrint on treatment in Hormone Receptor HR-positive HER2-negative breast cancer patients
In addition the impact of MammaPrint on treatment in patients with T1aT1b and pN0pN1 up to 1 node Triple Negative or HER2-positive tumors will be assessed
In addition the impact of MammaPrint on treatment in patients with T1aT1b and pN0pN1 up to 1 node Triple Negative or HER2-positive tumors will be assessed
Detailed Description:
Eligible patients will have their tumor sample analyzed for MammaPrint BluePrint and TargetPrint Patients cannot start treatment before the MammaPrint and BluePrint result is received and taken into consideration for the treatment plan The clinical data are to be entered online There will be 2 Case Report Forms CRFs Baseline clinical data and physician chemotherapy intention before knowing the MammaPrint and BluePrint result will be entered in CRF 1 After completion of CRF1 the MammaPrint and BluePrint result will be released CRF2 will be completed after the final treatment decision has been made This CRF will capture physician chemotherapy intention after the MammaPrint and BluePrint result and the impact of these results
A sample size of 331 patients is required to detect a 25 overall treatment change 5 significance and 95 power in stage I and II HR-positive HER2-negative patients receiving adjuvant therapy
In addition at least 50 T1abN01 up to 1 node Triple Negative at least 50 T1abN01 up to 1 node HER2-positive breast cancer patients and at least 50 patients receiving neoadjuvant therapy will be enrolled
A sample size of 331 patients is required to detect a 25 overall treatment change 5 significance and 95 power in stage I and II HR-positive HER2-negative patients receiving adjuvant therapy
In addition at least 50 T1abN01 up to 1 node Triple Negative at least 50 T1abN01 up to 1 node HER2-positive breast cancer patients and at least 50 patients receiving neoadjuvant therapy will be enrolled
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