Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00191152
Status:
COMPLETED
Last Update Posted:
2009-12-24
First Post:
2005-09-12
Brief Title:
A Phase III Trial For Patients With Metastatic Breast Cancer
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
Randomized Trial of Gemcitabine Plus Docetaxel vs Docetaxel Plus Capecitabine in Metastatic Breast Cancer in 1st and 2nd
Status:
COMPLETED
Status Verified Date:
2009-12
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:
None
Brief Summary:
This is a phase III randomized study between the docetaxelgemcitabine and docetaxel capecitabine doublets with crossover to the alternate agent The experimental arm will receive gemcitabine 1000 mgm2 intravenous IV over 30 minutes days 1 and 8 and docetaxel 75 mgm2 IV day 1 over 1 hour repeated every three weeks The comparator arm will receive docetaxel 75 mgmm2 IV day 1 over 1 hour and oral capecitabine 1000 mgm2 twice daily days 1 through 14 repeated every three weeks Patients who progress on the experimental arm will be treated with capecitabine as dosed on the comparator arm Patients who progress on the comparator arm will be treated with gemcitabine as dosed on the experimental arm
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| B9E-US-S188 | None | None | None |