Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128843
Status:
COMPLETED
Last Update Posted:
2023-03-06
First Post:
2005-08-09
Brief Title:
Exemestane Versus Anastrozole as First Line Hormone Therapy in Postmenopausal Metastatic Breast Cancer Patients
Sponsor:
Spanish Breast Cancer Research Group
Organization:
Spanish Breast Cancer Research Group
Study Overview
Official Title:
Phase II Randomized Multicenter Crossover Clinical Trial for Administration of Exemestane vs Anastrozole as First Line Treatment for Postmenopausal Patients With Hormone Receptor Positive Advanced Breast Cancer
Status:
COMPLETED
Status Verified Date:
2023-03
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 pivotal phase II multicenter open-label trial designed to compare the efficacy of exemestane versus anastrozole as a first line treatment for advanced breast cancer One hundred postmenopausal patients with metastatic positive hormone receptor breast cancer will be enrolled in this trial
Detailed Description:
The primary study endpoint is objective response rate The study has been designed following Simons test with a p1-p0015 p1 is the optimum level of activity of the experimental treatment exemestane and p0 is the minimum expected activity In this study p1 is 25 25 of RR and p0 is 10 10 of RR With an alpha error of 005 and a beta error of 01 Simon test establishes a first step of 21 patients per treatment arm If at least 2 objective responses are observed in exemestane arm recruitment will continue until 100 patients have been recruited After this second recruitment phase at least 7 objective responses must be observed to confirm the expected exemestane level of activity
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