Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00463788
Status:
COMPLETED
Last Update Posted:
2014-02-13
First Post:
2007-04-19
Brief Title:
Cetuximab and Cisplatin in the Treatment of Triple Negative Estrogen Receptor ER Negative Progesterone Receptor PgR Negative and Human Epidermal Growth Factor Receptor 2 HER2 Negative Metastatic Breast Cancer
Sponsor:
Merck KGaA Darmstadt Germany
Organization:
Merck KGaA Darmstadt Germany
Study Overview
Official Title:
Randomized Phase II Trial With Cetuximab and Cisplatin in the Treatment of ER-negative PgR-negative HER2-negative Metastatic Breast Carcinoma Basal Like
Status:
COMPLETED
Status Verified Date:
2014-01
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:
BALI-1
Brief Summary:
The primary objective of this study is to determine whether overall response to cetuximab combined with cisplatin is better than overall response to cisplatin alone together with showing that the overall response for cetuximab and cisplatin was above a pre-specified threshold of 02 in the treatment of triple negative metastatic breast cancer
The secondary objective of this study is to compare the differences between the two treatment groups using the following criteria Progression-Free Survival PFS Time Overall Survival OS Time to Response TTR and Safety
The secondary objective of this study is to compare the differences between the two treatment groups using the following criteria Progression-Free Survival PFS Time Overall Survival OS Time to Response TTR and Safety
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