Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003906
Status:
COMPLETED
Last Update Posted:
2015-10-06
First Post:
1999-11-01
Brief Title:
Study of Tamoxifen and Raloxifene STAR for the Prevention of Breast Cancer in Postmenopausal Women
Sponsor:
NSABP Foundation Inc
Organization:
NSABP Foundation Inc
Study Overview
Official Title:
Study of Tamoxifen and Raloxifene STAR for the Prevention of Breast Cancer
Status:
COMPLETED
Status Verified Date:
2015-10
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 raloxifene and tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells
PURPOSE Randomized double-blinded clinical trial to compare the effectiveness of raloxifene with that of tamoxifen in preventing breast cancer in postmenopausal women
PURPOSE Randomized double-blinded clinical trial to compare the effectiveness of raloxifene with that of tamoxifen in preventing breast cancer in postmenopausal women
Detailed Description:
OBJECTIVES
Determine whether raloxifene is more or less effective than tamoxifen in significantly reducing the incidence rate of invasive breast cancer in postmenopausal women
Evaluate the effects of tamoxifen and raloxifene on the incidence of intraductal carcinoma in situ lobular carcinoma in situ endometrial cancer ischemic heart disease fractures of the hip and spine or Colles fractures of the wrist in these participants
Evaluate the toxic effects of these regimens in these participants
Determine the effect of these regimens on the quality of life of these participants at selected centers Quality of life evaluation closed to accrual effective 53101
OUTLINE This is a randomized double-blind study Participants are stratified by age 35 to 49 vs 50 to 59 vs over 59 race black vs white vs other history of lobular carcinoma in situ yes vs no prior hysterectomy yes vs no and estimated absolute risk of invasive breast cancer within 5 years using the Gail modelless than 20 vs 20-29 vs 30-49 vs 50 or greater Participants are randomized to 1 of 2 arms
Arm I Participants receive oral tamoxifen plus placebo daily for 5 years
Arm II Participants receive oral raloxifene plus placebo daily for 5 years Quality of life is assessed at selected centers at baseline and at 6 12 18 24 30 36 42 48 54 60 and 72 months Quality of life evaluation closed to accrual effective 53101
Participants are followed annually after 5 years
PROJECTED ACCRUAL Approximately 19000 participants will be accrued for this study within 5 years
Determine whether raloxifene is more or less effective than tamoxifen in significantly reducing the incidence rate of invasive breast cancer in postmenopausal women
Evaluate the effects of tamoxifen and raloxifene on the incidence of intraductal carcinoma in situ lobular carcinoma in situ endometrial cancer ischemic heart disease fractures of the hip and spine or Colles fractures of the wrist in these participants
Evaluate the toxic effects of these regimens in these participants
Determine the effect of these regimens on the quality of life of these participants at selected centers Quality of life evaluation closed to accrual effective 53101
OUTLINE This is a randomized double-blind study Participants are stratified by age 35 to 49 vs 50 to 59 vs over 59 race black vs white vs other history of lobular carcinoma in situ yes vs no prior hysterectomy yes vs no and estimated absolute risk of invasive breast cancer within 5 years using the Gail modelless than 20 vs 20-29 vs 30-49 vs 50 or greater Participants are randomized to 1 of 2 arms
Arm I Participants receive oral tamoxifen plus placebo daily for 5 years
Arm II Participants receive oral raloxifene plus placebo daily for 5 years Quality of life is assessed at selected centers at baseline and at 6 12 18 24 30 36 42 48 54 60 and 72 months Quality of life evaluation closed to accrual effective 53101
Participants are followed annually after 5 years
PROJECTED ACCRUAL Approximately 19000 participants will be accrued for this study within 5 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 |
|---|---|---|---|
| CDR0000067081 | None | None | None |