Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00099281
Status:
TERMINATED
Last Update Posted:
2007-02-28
First Post:
2004-12-10
Brief Title:
DPPE in Combination With Epirubicin and Cyclophosphamide in the Treatment of Breast Cancer
Sponsor:
YM BioSciences
Organization:
YM BioSciences
Study Overview
Official Title:
A Phase III Study of DPPE Combined With Epirubicin and Cyclophosphamide vs Epirubicin and Cyclophosphamide Alone as First Line Treatment in MetastaticRecurrent Breast Cancer
Status:
TERMINATED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this trial is to study DPPE combined with epirubicin and cyclophosphamide in patients with metastatic andor recurrent breast cancer who may have received previous hormone treatment but have not had exposure to anthracycline treatment Stratification allocation will be within the following subgroups
1 Prior cytotoxic treatment
2 Estrogen receptor status
3 ECOG performance status
4 Number of cycles of chemotherapy
1 Prior cytotoxic treatment
2 Estrogen receptor status
3 ECOG performance status
4 Number of cycles of chemotherapy
Detailed Description:
Endpoints of the trial are as follows
primary overall survival secondary response rate progression free survival toxicity neurocognitive function
primary overall survival secondary response rate progression free survival toxicity neurocognitive function
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