Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440622
Status:
TERMINATED
Last Update Posted:
2013-02-13
First Post:
2007-02-26
Brief Title:
Study of Gemcitabine and Herceptin Versus Xeloda and Herceptin in HER-2 Metastatic Breast Cancer Patients
Sponsor:
Hellenic Oncology Research Group
Organization:
Hellenic Oncology Research Group
Study Overview
Official Title:
A Multicenter Randomized Phase III Study of Gemcitabine Plus Herceptin Combination Versus the Capecitabine Plus Herceptin Combination in Pretreated Patients With HER-2 Positive Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The optimal treatment for pretreated patients with metastatic breast cancer has not been established Gemcitabine and capecitabine are two active agents in this setting For women with Her-2 positive breast cancer combinations of either gemcitabine or capecitabine Xeloda plus Herceptin has been proved active and well tolerated
Detailed Description:
This trial compares the efficacy of the combinations gemcitabine plus Herceptin versus capecitabine Xeloda plus Herceptin in pretreated patients with metastatic HER-2 positive 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