Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05722795
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-10
First Post:
2022-04-11
Brief Title:
Use of Imatinib to Convert Triple Negative Breast Cancer Into ER-positive Breast Cancer I-CONIC
Sponsor:
Vastra Gotaland Region
Organization:
Vastra Gotaland Region
Study Overview
Official Title:
Use of Imatinib to Convert Triple Negative Breast Cancer Into ER-positive Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-04
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:
I-CONIC
Brief Summary:
This is a single centre Window-of-Opportunity trial investigating the efficacy and feasibility of short term imatinib in patients with newly diagnosed triple negative breast cancer TNBC planned for surgery with tumours 15 mm any status in the axilla when neoadjuvant treatment not is considered as an option
The primary aim is to determine the proportion of patients that converts to estrogen receptor ER positive breast cancer in the removed breast cancer tissue at surgery
The primary aim is to determine the proportion of patients that converts to estrogen receptor ER positive breast cancer in the removed breast cancer tissue at surgery
Detailed Description:
This is a single centre Window-of-Opportunity trial that will investigate the efficacy and feasibility of short term 10 days imatinib in patients with newly diagnosed TNBC planned for surgery with tumours 15 mm any status in the axilla and when neoadjuvant treatment not is considered as an option Imatinib is given at a dose of 400 mg daily
The primary aim is to determine the proportion of patients that converts to ER positive breast cancer in the removed breast cancer tissue at surgery
The secondary aim is to evaluate the safety and adverse events AE will be collected throughout the study from informed consent until 30 days after the last dose of the IMP imatinib
AEs will be graded according to National Cancer Institute NCI Common Terminology Criteria for Adverse Events CTCAE version 50
The primary aim is to determine the proportion of patients that converts to ER positive breast cancer in the removed breast cancer tissue at surgery
The secondary aim is to evaluate the safety and adverse events AE will be collected throughout the study from informed consent until 30 days after the last dose of the IMP imatinib
AEs will be graded according to National Cancer Institute NCI Common Terminology Criteria for Adverse Events CTCAE version 50
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None