Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00152191
Status:
COMPLETED
Last Update Posted:
2011-07-07
First Post:
2005-09-07
Brief Title:
A Randomized Controlled Study of Postoperative Adjuvant Therapy of Uracil-tegafur UFT Compared With CyclophosphamideMethotrexate5-fluorouracil CMF in Breast Cancer NSAS-BC
Sponsor:
Taiho Pharmaceutical Co Ltd
Organization:
Taiho Pharmaceutical Co Ltd
Study Overview
Official Title:
A Randomized Controlled Study of Postoperative Adjuvant Therapy of UFT Compared With CMF in High-risk Women With Axillary Node-negative Breast Cancer NSAS-BC
Status:
COMPLETED
Status Verified Date:
2011-07
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:
This is a randomized controlled study designed to evaluate the relapse-free survival of the UFT group compared with the CMF group Patients will be randomly assigned to receive either CMF or UFT within 12 weeks after curative resection To evaluate treatment efficacy data on recurrence and survival will be collected for up to 10 years after enrollment of the final patient To assess safety data on adverse events will be collected for 2 years after the start of treatment Patientsquality of life will be assessed by means of a questionnaire
Detailed Description:
None
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