Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00250874
Status:
UNKNOWN
Last Update Posted:
2005-11-08
First Post:
2005-11-07
Brief Title:
Myocet Docetaxel Trastuzumab as 1st Line Treatment of Patients With HER-2Neu Positive Metastatic Breast Cancer
Sponsor:
Zeneus Pharma
Organization:
Zeneus Pharma
Study Overview
Official Title:
Phase I-II Study of Liposomal Doxorubicin Myocet Docetaxel and Trastuzumab as First-Line Treatment of Patients With HER-2Neu Positive Metastatic Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2005-11
Last Known Status:
RECRUITING
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:
To study the pharmacokinetic profile of the therapeutic schedule in order to demonstrate absence of negative interactions among the 3 drugs administered
Detailed Description:
1 To assess the maximum tolerated dose MTD of Myocet at different dosages in combination with Taxotere at the fixed dose of 35 mgm2 on day 2 and 9 every 21 days and weekly Herceptin as first line therapy in patients affected by HER-2neu positive metastatic breast cancer
2 To enhance the proportion of complete remission
3 To allow the feasibility of the combination of Herceptin with both Myocet and Taxotere without an enhanced risk of cardiotoxicity
2 To enhance the proportion of complete remission
3 To allow the feasibility of the combination of Herceptin with both Myocet and Taxotere without an enhanced risk of cardiotoxicity
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