Ignite Creation Date:
2024-05-05 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 9:39 AM
Study NCT ID:
NCT00580112
Status:
COMPLETED
Last Update Posted:
2014-02-25
First Post:
2007-12-20
Brief Title:
An Efficacy Study of Trabectedin in the Treatment of Participants With Specific Subtypes of Metastatic Breast Cancer
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
Phase II Multicenter Open-label Clinical Trial of Trabectedin Yondelis in Metastatic Breast Cancer Patients With Triple Negative Profile ER- PR- HER2- HER2 Overexpressing Tumors and BRCA1 or BRCA2 Mutation Carriers
Status:
COMPLETED
Status Verified Date:
2014-02
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 this study is to evaluate the effectiveness and safety of trabectedin in 3 subpopulations of participants with previously treated progressive metastatic spread of a cancer from one organ or part to another non-adjacent organ or part breast cancer abnormal tissue that grows and spreads in the body until it kills participants
Detailed Description:
This is an open-label all people know the identity of the intervention prospective study following participants forward in time multi-center when more than 1 hospital or medical school team work on a medical research study study evaluating the effectiveness and safety of trabectedin in 3 subpopulations of breast cancer participants Group A triple negative profile for estrogen receptor progesterone receptor and human estrogen receptor Group B human epidermal growth factor receptor-2 overexpressing tumors HER-2 and Group C familial breast cancer gene 1 BRCA1 or breast cancer gene 2 BRCA2 mutation carrier Participants will receive trabectedin 13 milligram per square meter mgm2 intravenous infusion a fluid or a medicine delivered into a vein by way of a needle over 3-hour every 3 weeks on Day 1 of each cycle Each cycle length will be 3 weeks Treatment will be continued until disease progression unmanageable toxicity participant refusal or treatment delay no longer than 3 weeks due to toxicity Efficacy will be primarily evaluated by percentage of participants with confirmed objective response by independent external review and Investigators assessment Participants safety 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 |
|---|---|---|---|
| ET-B-027-06 | OTHER | Johnson Johnson Pharmaceutical Research and Development LLC | None |