Ignite Creation Date:
2024-05-05 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 9:50 AM
Study NCT ID:
NCT00689156
Status:
COMPLETED
Last Update Posted:
2018-04-05
First Post:
2008-05-29
Brief Title:
Epirubicin or Not in Patients With TOP2A Topoisomerase DNA II Alpha 170kD Normal Early Breast Cancer
Sponsor:
Danish Breast Cancer Cooperative Group
Organization:
Danish Breast Cancer Cooperative Group
Study Overview
Official Title:
Randomized Trial of Epirubicin and Cyclophosphamide Followed by Docetaxel Against Docetaxel and Cyclophosphamide in Patients With TOP2A Normal Early Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
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:
READ
Brief Summary:
The Danish Breast Cancer Cooperative Group DBCG wishes to clarify if recurrence-free and overall life expectancy is longer after docetaxel and cyclophosphamide compared to epirubicin and cyclophosphamide followed by docetaxel in patients with TOP2A normal and operable breast cancer
Detailed Description:
In DBCG trial 89D we in more than 1200 patients showed that substitution in CMF chemotherapy of methotrexate with epirubicin improves survival for patients with primary and operable breast cancer In a retrospective evaluation we have also shown that approximately 20 of all patients in 89D have tumors with numerical changes of the TOP2A gene and that only patients with abnormal TOP2A benefit from epirubicin In the current trial the DBCG wishes to clarify if recurrence-free and overall life expectancy is longer after docetaxel and cyclophosphamide compared to epirubicin and cyclophosphamide followed by docetaxel in patients with TOP2A normal and operable breast cancer
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