Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082095
Status:
TERMINATED
Last Update Posted:
2014-10-09
First Post:
2004-04-29
Brief Title:
To Compare Treatment With Doxorubicin or Capecitabine for Metastatic Breast Cancer in Women 60 Years and Older
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Randomized Open-Label Trial Comparing Treatment With Either Pegylated Liposomal Doxorubicin or Capecitabine as First Line Chemotherapy for Metastatic Breast Cancer in Women 60 Years and Older
Status:
TERMINATED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated due to poor recruitment after enrolling 62 of planned 300 patients in 20 months
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of this study is to compare treatment with either pegylated liposomal doxorubicin or capecitabine as first line chemotherapy for metastatic breast cancer in women 60 years and older
Detailed Description:
This is an open-label all people know the identity of the intervention randomized the study medication is assigned by chance multicenter study comparing with pegylated liposomal doxorubicin PLD with capecitabine as first line chemotherapy of metastatic breast cancer in women 60 years and older The study consists of a screening Phase up to 14 days prior to treatment treatment phase up to 1 year and post-treatment follow-up phase The planned duration of treatment was 1 year in the absence of disease progression or unacceptable toxicity Approximately 300 patients will be enrolled and randomly assigned to receive 1 of 2 treatment groups PLD or capecitabine Safety evaluations will consist of vital sign examination physical examination incidence and severity of adverse events and laboratory tests findings and will be followed 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 |
|---|---|---|---|
| DO03-21-022 | OTHER | Johnson Johnson Pharmaceutical Research and Development LLC | None |