Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010153
Status:
TERMINATED
Last Update Posted:
2012-07-19
First Post:
2001-02-02
Brief Title:
ICI 182780 in Treating Women With Stage I or Stage II Primary Breast Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
A Double-Blind Phase III Clinical Trial to Compare the Effects of a Pre-Operatively Administered Single Dose of Faslodex Long-Acting ICI 182780 With Placebo on Tumor Recurrence in Pre- and Postmenopausal Women Treated for Operable First Primary Breast Cancer
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
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 Hormone therapy using ICI 182780 before surgery may block the uptake of estrogen by the tumor cells and prevent metastases It is not yet known if ICI 182780 is effective in preventing breast cancer metastases
PURPOSE Randomized phase III trial to study the effectiveness of ICI 182780 given before surgery in treating women who have stage I or stage II primary breast cancer
PURPOSE Randomized phase III trial to study the effectiveness of ICI 182780 given before surgery in treating women who have stage I or stage II primary breast cancer
Detailed Description:
OBJECTIVES
Determine the inhibitory effect of ICI 182780 on the development of metastasis as measured by disease-free survival and overall survival in women with operable stage I or II primary breast cancer
Determine toxicity of this regimen in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to participating center and menopausal status premenopausal vs postmenopausal
Patients are randomized to receive either ICI 182780 IM or placebo IM over 2 minutes on day 1 Patients undergo surgery between days 8 and 29
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 3656 patients 1828 per arm will be accrued for this study within 2 years
Determine the inhibitory effect of ICI 182780 on the development of metastasis as measured by disease-free survival and overall survival in women with operable stage I or II primary breast cancer
Determine toxicity of this regimen in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to participating center and menopausal status premenopausal vs postmenopausal
Patients are randomized to receive either ICI 182780 IM or placebo IM over 2 minutes on day 1 Patients undergo surgery between days 8 and 29
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 3656 patients 1828 per arm will be accrued for this study within 2 years
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 |
|---|---|---|---|
| BIG-EORTC-10963 | None | None | None |
| EORTC-10963 | None | None | None |