Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091442
Status:
COMPLETED
Last Update Posted:
2014-04-21
First Post:
2004-09-08
Brief Title:
A Study of Docetaxel Monotherapy or DOXIL and Docetaxel in Patients With Advanced Breast Cancer
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Randomized Controlled Study of Docetaxel Monotherapy or Docetaxel and DOXIL for the Treatment of Advanced Breast Cancer
Status:
COMPLETED
Status Verified Date:
2014-04
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:
The purpose of the study is to evaluate whether the time to progression for the DOXIL and docetaxel combination therapy group was superior to that of the group treated with docetaxel monotherapy in participants with advanced breast cancer
Detailed Description:
This is a randomized the study medication is assigned by a random order active control study medication will be compared with available standard care of treatment parallel-group each treatment group will be treated simultaneously at the same time and each participant only receives one treatment regimen as assigned open-label both the investigator and the participant know the intervention received by the participant multicenter study designed to determine if women with locally advanced or metastatic breast cancer who were previously treated with prior anthracycline therapy in the neoadjuvant administration of treatment before surgery or adjuvant setting administration of treatment after surgery and who also had a disease-free interval of at least 12 months since the end of their last cytotoxic therapy would benefit from the addition of DOXIL to docetaxel therapy Approximately 751 participants will be randomly assigned to either receive docetaxel monotherapy or DOXIL in combination with docetaxel therapy Treatment is to continue until disease progression or the occurrence of unacceptable treatment related toxicity Safety evaluations will include assessments of adverse events which will be recorded from the first study related procedure until 30 days after the last dose of medication clinical laboratory tests and tests for cardiac function multiple gated acquisition scanechocardiogram and electrocardiogram which will be monitored throughout the study
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 |
|---|---|---|---|
| DOXILBCA3001 | OTHER | Johnson Johnson Pharmaceutical Research Development LLC | None |