Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053898
Status:
COMPLETED
Last Update Posted:
2018-09-20
First Post:
2003-02-05
Brief Title:
Anastrozole or Tamoxifen in Treating Postmenopausal Women With Ductal Carcinoma in Situ Who Are Undergoing Lumpectomy and Radiation Therapy
Sponsor:
NSABP Foundation Inc
Organization:
NSABP Foundation Inc
Study Overview
Official Title:
A Clinical Trial Comparing Anastrozole With Tamoxifen in Postmenopausal Patients With Ductal Carcinoma in Situ DCIS Undergoing Lumpectomy With Radiation Therapy
Status:
COMPLETED
Status Verified Date:
2018-09
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 Tamoxifen may fight breast cancer by blocking the use of estrogen Anastrozole may fight breast cancer by decreasing estrogen production It is not yet known whether anastrozole is more effective than tamoxifen in preventing the recurrence of breast cancer
PURPOSE This randomized phase III trial is studying anastrozole to see how well it works compared to tamoxifen in preventing the recurrence of breast cancer in postmenopausal women with ductal carcinoma in situ who are undergoing lumpectomy and radiation therapy
PURPOSE This randomized phase III trial is studying anastrozole to see how well it works compared to tamoxifen in preventing the recurrence of breast cancer in postmenopausal women with ductal carcinoma in situ who are undergoing lumpectomy and radiation therapy
Detailed Description:
OBJECTIVES
Compare the value of anastrozole vs tamoxifen in terms of preventing recurrence ie local regional and distant recurrences and contralateral breast cancer after lumpectomy and radiotherapy in postmenopausal women with ductal carcinoma in situ DCIS
Compare subsequent disease occurrence in terms of invasive breast cancer local regional distant or contralateral ipsilateral and contralateral breast cancer invasive and DCIS and non-breast second primary malignancies in patients treated with these drugs
Compare quality of life and symptoms of patients treated with these drugs
Compare quality-adjusted survival time of patients treated with these drugs
Compare the occurrence of osteoporotic fractures in patients treated with these drugs
Compare disease-free and overall survival of patients treated with these drugs NOTE The quality of life study closed to accrual as of 122804
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to age under 60 vs 60 and over Patients are randomized to 1 of 2 treatment arms arm I and arm II closed to accrual as of 61506
Arm I closed to accrual as of 61506 Patients receive oral tamoxifen and oral placebo once daily for 5 years
Arm II closed to accrual as of 61506 Patients receive oral anastrozole and oral placebo once daily for 5 years
Beginning within 8 weeks of randomization all patients also undergo whole breast radiotherapy unless the patient is enrolled in protocol NSABP-B-39 and randomized to the partial breast irradiation group
Patients are followed every 6 months for 5 years and then annually thereafter
For patients enrolled in the quality of life study quality of life is assessed at baseline and then every 6 months for 6 years
NOTE The quality of life study closed to accrual as of 122804
PROJECTED ACCRUAL A total of 3000 patients 1500 per treatment arm will be accrued for this study within 5 years arm I and arm II closed to accrual as of 61506
Compare the value of anastrozole vs tamoxifen in terms of preventing recurrence ie local regional and distant recurrences and contralateral breast cancer after lumpectomy and radiotherapy in postmenopausal women with ductal carcinoma in situ DCIS
Compare subsequent disease occurrence in terms of invasive breast cancer local regional distant or contralateral ipsilateral and contralateral breast cancer invasive and DCIS and non-breast second primary malignancies in patients treated with these drugs
Compare quality of life and symptoms of patients treated with these drugs
Compare quality-adjusted survival time of patients treated with these drugs
Compare the occurrence of osteoporotic fractures in patients treated with these drugs
Compare disease-free and overall survival of patients treated with these drugs NOTE The quality of life study closed to accrual as of 122804
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to age under 60 vs 60 and over Patients are randomized to 1 of 2 treatment arms arm I and arm II closed to accrual as of 61506
Arm I closed to accrual as of 61506 Patients receive oral tamoxifen and oral placebo once daily for 5 years
Arm II closed to accrual as of 61506 Patients receive oral anastrozole and oral placebo once daily for 5 years
Beginning within 8 weeks of randomization all patients also undergo whole breast radiotherapy unless the patient is enrolled in protocol NSABP-B-39 and randomized to the partial breast irradiation group
Patients are followed every 6 months for 5 years and then annually thereafter
For patients enrolled in the quality of life study quality of life is assessed at baseline and then every 6 months for 6 years
NOTE The quality of life study closed to accrual as of 122804
PROJECTED ACCRUAL A total of 3000 patients 1500 per treatment arm will be accrued for this study within 5 years arm I and arm II closed to accrual as of 61506
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 |
|---|---|---|---|
| ACOSOG-NSABP-B-35 | None | None | None |
| NSABP-B-35 | None | None | None |
| SWOG-NSABP-B-35 | None | None | None |
| NCCTG-NSABP-B-35 | None | None | None |