Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010140
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2001-02-02
Brief Title:
Epirubicin and Tamoxifen With or Without Docetaxel in Treating Postmenopausal Women With Breast Cancer
Sponsor:
International Collaborative Cancer Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Multicenter Randomized Trial of Sequential Epirubicin and Docetaxel Versus Epirubicin in Node Positive Postmenopausal Breast Cancer Patients
Status:
UNKNOWN
Status Verified Date:
2005-09
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells Combining chemotherapy with hormone therapy may kill more tumor cells
PURPOSE Randomized phase III trial to compare the effectiveness of epirubicin and tamoxifen with or without docetaxel in treating postmenopausal women who have breast cancer that has spread to the lymph nodes
PURPOSE Randomized phase III trial to compare the effectiveness of epirubicin and tamoxifen with or without docetaxel in treating postmenopausal women who have breast cancer that has spread to the lymph nodes
Detailed Description:
OBJECTIVES
Compare the impact of adjuvant epirubicin with or without docetaxel and concurrent or sequential tamoxifen on time to relapse and overall survival in postmenopausal women with node-positive breast cancer
Compare the toxic effects of these regimens in this patient population
Compare the quality of life in terms of shift in long term toxicity and differences in recuperation in women treated with these regimens
Compare the incidence of thromboembolic events during the first 9 months of study and the influence of such events on compliance in women treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center Patients are randomized to one of two adjuvant chemotherapy treatment arms within 30 days after surgery
Arm I Patients receive adjuvant epirubicin IV on days 1 and 8 Treatment continues every 28 days for 6 courses
Arm II Patients receive adjuvant epirubicin IV on days 1 and 8 Treatment continues every 28 days for 3 courses Patients then receive docetaxel IV over 1 hour on day 1 Treatment continues every 21 days for 3 courses
Patients may be further randomized to one of two tamoxifen arms Patients not randomized to the tamoxifen arms receive oral tamoxifen daily for 5 years concurrently with adjuvant chemotherapy
Arm I Patients receive tamoxifen as above concurrently with adjuvant chemotherapy
Arm II Patients receive sequential tamoxifen as above after completion of adjuvant chemotherapy
Quality of life is assessed at baseline 9 months 2 years and then at 5 years
Patients are followed at 9 months 1 year every 4 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 800 patients will be accrued for this study
Compare the impact of adjuvant epirubicin with or without docetaxel and concurrent or sequential tamoxifen on time to relapse and overall survival in postmenopausal women with node-positive breast cancer
Compare the toxic effects of these regimens in this patient population
Compare the quality of life in terms of shift in long term toxicity and differences in recuperation in women treated with these regimens
Compare the incidence of thromboembolic events during the first 9 months of study and the influence of such events on compliance in women treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center Patients are randomized to one of two adjuvant chemotherapy treatment arms within 30 days after surgery
Arm I Patients receive adjuvant epirubicin IV on days 1 and 8 Treatment continues every 28 days for 6 courses
Arm II Patients receive adjuvant epirubicin IV on days 1 and 8 Treatment continues every 28 days for 3 courses Patients then receive docetaxel IV over 1 hour on day 1 Treatment continues every 21 days for 3 courses
Patients may be further randomized to one of two tamoxifen arms Patients not randomized to the tamoxifen arms receive oral tamoxifen daily for 5 years concurrently with adjuvant chemotherapy
Arm I Patients receive tamoxifen as above concurrently with adjuvant chemotherapy
Arm II Patients receive sequential tamoxifen as above after completion of adjuvant chemotherapy
Quality of life is assessed at baseline 9 months 2 years and then at 5 years
Patients are followed at 9 months 1 year every 4 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 800 patients 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 |
|---|---|---|---|
| EU-20040 | None | None | None |
| ICCG-C1496 | None | None | None |