Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer in Postmenopausal Women
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|ClinicalTrials.gov Identifier: NCT00003906|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 6, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Raloxifene Drug: Tamoxifen||Phase 3|
- 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 5/31/01.)
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 model)(less than 2.0 vs 2.0-2.9 vs 3.0-4.9 vs 5.0 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 5/31/01.)
Participants are followed annually after 5 years.
PROJECTED ACCRUAL: Approximately 19,000 participants will be accrued for this study within 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19747 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer|
|Study Start Date :||May 1999|
|Primary Completion Date :||December 2005|
|Study Completion Date :||August 2012|
Active Comparator: Group 1
Tamoxifen and placebo
20 mg/day plus placebo for 5 years
Experimental: Group 2
Raloxifene and Placebo
60 mg/day plus placebo for 5 years
- Incidence of invasive breast cancer; superiority of one of the therapies. [ Time Frame: Time from randomization to the occurance of invasive breast cancer. ]
Determine which of the following is true:
- compared to tamoxifen, raloxifene significantly reduces the incidence rate of invasive breast cancer;
- compared to raloxifene, tamoxifen significantly reduces the incidence rate of invasive breast cancer; or
- the statistical superiority of one of the treatments cannot be demonstrated and the choice of therapy should be based on benefit/risk considerations.
- Effect of the study therapies on the incidence of intraductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS). [ Time Frame: Time from randomization to the occurance of DCIS or LCIS. ]
- Effect of the study therapies on the incidence of endometrial cancer. [ Time Frame: Time from randomization to the occurance of endometrial cancer. ]
- Effect of the study therapies on the incidence of ischemic heart disease. [ Time Frame: Time from randomization to the occurance of ischimic heart disease. ]
- Effect of the study therapies on the incidence of fractures of the hip, spine, or Colles' fractures of the wrist. [ Time Frame: Time from randomization to the occurance of fractures of the hip, spine, or Colles' fractures of the wrist. ]
- Effect of the study therapies on the toxicity and side effects of each therapy. [ Time Frame: Incidences of protocol defined toxicities and side effects. ]
- Effect of the study therapies on participants' quality of life. [ Time Frame: pre-entry, every 6 months for 5 years, and then annual after 5 years following randomization. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003906
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|Study Chair:||Norman Wolmark, MD||NSABP Foundation Inc|