Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00193076
Status:
COMPLETED
Last Update Posted:
2011-05-03
First Post:
2005-09-12
Brief Title:
Combination Gemcitabine Carboplatin With or Without Trastuzumab in Patients With Metastatic Breast Cancer
Sponsor:
SCRI Development Innovations LLC
Organization:
SCRI Development Innovations LLC
Study Overview
Official Title:
A Phase II Trial of Combination Gemcitabine Carboplatin With or Without Trastuzumab in Patients With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2011-05
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:
Pre-clinical data suggests that combination therapy with gemcitabine and carboplatin is synergistic and both drugs may be synergistic with trastuzumab Additionally recent clinical data suggest that the combination of gemcitabine with platinum is an active regimen in metastatic breast cancer This study will test the combination of gemcitabine with carboplatin in patients with metastatic breast cancer Patients with Her2neu overexpression will be stratified to receive trastuzumab in addition to gemcitabine and carboplatin
Detailed Description:
Upon determination of eligibility all patients will receive the following treatment
Gemcitabine Carboplatin
Gemcitabine Carboplatin
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 |
|---|---|---|---|
| H3036S | None | None | None |
| B9E-US-S324 | None | None | None |