Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003418
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Exemestane Compared With Tamoxifen in Treating Postmenopausal Women With Primary Breast Cancer
Sponsor:
International Collaborative Cancer Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Double-Blind Trial in Postmenopausal Women With Primary Breast Cancer Who Have Received Adjuvant Tamoxifen for 2-3 Years Comparing Subsequent Adjuvant Exemestane Treatment With Further Tamoxifen
Status:
UNKNOWN
Status Verified Date:
2008-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
RATIONALE Estrogen can stimulate the growth of breast cancer cells Hormone therapy using exemestane or tamoxifen may fight breast cancer by blocking the uptake of estrogen It is not yet known whether exemestane is more effective than tamoxifen in treating breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of exemestane with that of tamoxifen in treating postmenopausal women with primary breast cancer who have already received 2-3 years of tamoxifen following surgery
PURPOSE Randomized phase III trial to compare the effectiveness of exemestane with that of tamoxifen in treating postmenopausal women with primary breast cancer who have already received 2-3 years of tamoxifen following surgery
Detailed Description:
OBJECTIVES I Compare in terms of disease-free survival and overall survival the sequential administration of exemestane with administration of further tamoxifen until 5 years of therapy is achieved in postmenopausal women with operable breast cancer who have already received 2-3 years of adjuvant tamoxifen II Compare the regimens in terms of the incidence of contralateral breast cancer and long term tolerability of the regimens in these patients III Determine the tolerability of each regimen in terms of endometrial status bone metabolism lipid profile and coagulation profile in these patients IV Assess quality of life in these patients treated with these regimens
OUTLINE This is a randomized double blind multicenter study Following 2-3 years of adjuvant treatment with tamoxifen patients are randomized to receive either oral tamoxifen daily or oral exemestane daily for the remainder of the 5 year period in the absence of disease relapse or unacceptable toxicity Quality of life is assessed at some centers Patients are followed at least every 3 months for the first year of treatment every 6 months for the next two years and then annually thereafter until year 10
PROJECTED ACCRUAL Approximately 4400 patients 2200 patients in each arm will be accrued for this study
OUTLINE This is a randomized double blind multicenter study Following 2-3 years of adjuvant treatment with tamoxifen patients are randomized to receive either oral tamoxifen daily or oral exemestane daily for the remainder of the 5 year period in the absence of disease relapse or unacceptable toxicity Quality of life is assessed at some centers Patients are followed at least every 3 months for the first year of treatment every 6 months for the next two years and then annually thereafter until year 10
PROJECTED ACCRUAL Approximately 4400 patients 2200 patients in each arm will be accrued for this 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 |
|---|---|---|---|
| ICCG-BIG-9702 | None | None | None |
| ICCG-96OEXE031-C1396-BIG9702 | None | None | None |
| EORTC-10967 | None | None | None |
| FRE-FNCLCC-PACS0296OEXE031 | None | None | None |
| EU-20013 | None | None | None |
| EU-99002 | None | None | None |