Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00434941
Status:
TERMINATED
Last Update Posted:
2019-02-21
First Post:
2007-02-13
Brief Title:
Capecitabine Plus Radiotherapy for Local Relapse Breast Cancer With Negative Her2 Tumours
Sponsor:
Spanish Breast Cancer Research Group
Organization:
Spanish Breast Cancer Research Group
Study Overview
Official Title:
Multicenter Phase IVII Trial for the Administration of Capecitabine Simultaneous to Radiotherapy for Local Relapse Breast Cancer Patients With Negative Her2 Tumours
Status:
TERMINATED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to the slow rate of recruitment the study was stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective open-label multicenter phase IVII study Patients with local relapse breast cancer will receive radiotherapy concomitant to the administration of capecitabine
Detailed Description:
Total dose of radiotherapy will be 50 Gy administered in daily session of 200 centigray cGy Radiotherapy treatment will not be longer than 6 weeks
All patients will receive 1650 mgm2 by mouth per day 825 mgm2 twice a day po bid for 35 days
Tissue samples must be analysed to determinate the human epidermal growth factor receptor-2 HER2 by fluorescent in situ hybridization FISH technical
All patients will receive 1650 mgm2 by mouth per day 825 mgm2 twice a day po bid for 35 days
Tissue samples must be analysed to determinate the human epidermal growth factor receptor-2 HER2 by fluorescent in situ hybridization FISH technical
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