Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010322
Status:
TERMINATED
Last Update Posted:
2014-03-26
First Post:
2001-02-02
Brief Title:
Toremifene With or Without Atamestane in Treating Postmenopausal Women With Metastatic Breast Cancer
Sponsor:
Intarcia Therapeutics
Organization:
Intarcia Therapeutics
Study Overview
Official Title:
Phase III Study of Atamestane Plus Toremifene in Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn due to change in standard of care - new protocol required
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Estrogen can stimulate the growth of breast cancer cells Toremifene may fight breast cancer by blocking the uptake of estrogen by the tumor cells Atamestane may fight breast cancer by blocking the production of estrogen It is not yet known if toremifene is more effective with or without atamestane
PURPOSE Randomized phase III trial to compare the effectiveness of toremifene with or without atamestane in treating postmenopausal women who have metastatic breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of toremifene with or without atamestane in treating postmenopausal women who have metastatic breast cancer
Detailed Description:
OBJECTIVES I Compare the time to progression in postmenopausal women with metastatic breast cancer treated with toremifene with or without atamestane II Compare the response rate overall survival duration of response and time to treatment failure in patients treated with these regimens III Compare the safety profile of these regimens in this patient population
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to study center Patients are randomized to one of two treatment arms Arm I Patients receive oral toremifene daily and oral atamestane twice daily Arm II Patients receive oral toremifene as in arm I and an oral placebo twice daily Treatment continues for 12-30 months in the absence of disease progression or unacceptable toxicity Patients are followed every 12 weeks for survival
PROJECTED ACCRUAL A total of 594 patients 297 per treatment arm will be accrued for this study within 18 months
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to study center Patients are randomized to one of two treatment arms Arm I Patients receive oral toremifene daily and oral atamestane twice daily Arm II Patients receive oral toremifene as in arm I and an oral placebo twice daily Treatment continues for 12-30 months in the absence of disease progression or unacceptable toxicity Patients are followed every 12 weeks for survival
PROJECTED ACCRUAL A total of 594 patients 297 per treatment arm will be accrued for this study within 18 months
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 |
|---|---|---|---|
| BIOMED-777-CLP-27 | None | None | None |