Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-26 @ 5:01 AM
Study NCT ID:
NCT00377559
Status:
COMPLETED
Last Update Posted:
2015-10-06
First Post:
2006-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liposomal Doxorubicin and Docetaxel in HER2 Negative Metastatic Breast Cancer
Sponsor:
Catharina Ziekenhuis Eindhoven
Organization:
Study Overview
Official Title:
Phase II Multicentre Open Label Trial Evaluating the Efficacy and Safety of the Liposomal Doxorubicin (Myocet®) and Docetaxel (Taxotere®) Combination as First-line Treatment of Patients With Metastatic HER2/Neu Negative Breast Cancer
Status:
COMPLETED
Status Verified Date:
2011-08
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:
MYOTAX
Brief Summary:
This is an open phase II multicentre study evaluating the efficacy and safety of the non pegylated liposomal doxorubicin (Myocet®) and docetaxel (Taxotere®) combination as first-line treatment of patients with metastatic HER2/neu negative breast cancer.
Detailed Description:
Phase II non comparative study, assessing the safety (primarily cardiac safety) and efficacy in patients with locally advanced or metastatic HER2/neu negative breast cancer not yet treated with chemotherapy for metastatic disease.
Myocet and Taxotere will be given for a maximum of 6 cycles. Endpoints: cardiotoxicity (left ventricular ejection fraction decrease and/or symptoms of heart failure), serious other toxicity, disease progression.
Myocet and Taxotere will be given for a maximum of 6 cycles. Endpoints: cardiotoxicity (left ventricular ejection fraction decrease and/or symptoms of heart failure), serious other toxicity, disease progression.
Study Oversight
Has Oversight DMC:
False
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?: