Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032136
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
2002-03-08
Brief Title:
Exemestane Compared With Tamoxifen in Treating Postmenopausal Women With Breast Cancer
Sponsor:
Cancer Research Campaign Clinical Trials Centre
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
An Open Label Randomized Multicenter Comparative Trial Of 5 Years Adjuvant Exemestane Treatment Versus 5 Years Adjuvant Tamoxifen Treatment In Postmenopausal Women With Early Breast Cancer
Status:
COMPLETED
Status Verified Date:
2007-03
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:
RATIONALE Estrogen can stimulate the growth of breast cancer cells Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen It is not yet known if exemestane is more effective than tamoxifen in preventing the recurrence of breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of exemestane with that of tamoxifen in treating postmenopausal women who have undergone surgery to remove early-stage breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of exemestane with that of tamoxifen in treating postmenopausal women who have undergone surgery to remove early-stage breast cancer
Detailed Description:
OBJECTIVES
Compare the efficacy and tolerability of adjuvant exemestane versus adjuvant tamoxifen in postmenopausal women with early breast cancer
Compare the relapse-free survival and overall survival of patients treated with these drugs
Compare the incidence of contralateral breast cancer in patients treated with these drugs
Compare the safety and long-term tolerability of these drugs in these patients
Compare the quality of life of patients treated with these drugs
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to estrogen receptor ERprogesterone receptor PgR status ER positive vs ER negativePgR positive vs ER positivePgR unknown prior chemotherapy none vs taxane-based vs anthracycline-based vs other and nodal status negative vs 1-3 nodes positive vs 4 or more nodes positive Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral tamoxifen once daily
Arm II Patients receive oral exemestane once daily Treatment in both arms continues for a minimum of 5 years in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and at months 3 and 12 during study
Patients are followed at least annually
PROJECTED ACCRUAL Approximately 4400 patients 2200 per treatment arm will be accrued for this study
Compare the efficacy and tolerability of adjuvant exemestane versus adjuvant tamoxifen in postmenopausal women with early breast cancer
Compare the relapse-free survival and overall survival of patients treated with these drugs
Compare the incidence of contralateral breast cancer in patients treated with these drugs
Compare the safety and long-term tolerability of these drugs in these patients
Compare the quality of life of patients treated with these drugs
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to estrogen receptor ERprogesterone receptor PgR status ER positive vs ER negativePgR positive vs ER positivePgR unknown prior chemotherapy none vs taxane-based vs anthracycline-based vs other and nodal status negative vs 1-3 nodes positive vs 4 or more nodes positive Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral tamoxifen once daily
Arm II Patients receive oral exemestane once daily Treatment in both arms continues for a minimum of 5 years in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and at months 3 and 12 during study
Patients are followed at least annually
PROJECTED ACCRUAL Approximately 4400 patients 2200 per treatment arm will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000069260 | REGISTRY | None | None |
| EU-20149 | None | None | None |
| ISRCTN75225940 | Registry Identifier | PDQ Physician Data Query | None |