Phase III Randomized Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer in Postmenopausal Women
Last Modified: 2/18/2009  First Published: 7/1/1999
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outline Published Results Related Publications Trial Contact Information Related Information Registry Information
Alternate Title
Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer in Postmenopausal Women
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
---|
Phase III | Prevention | Closed | 35 and over | NSABP-P-2 NCT00003906 |
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 5/31/01.)
Entry Criteria Disease Characteristics:
- Postmenopausal women at increased risk for developing invasive breast
cancer,
who meet one of the following criteria:
- At least 12 months since spontaneous menstrual
bleeding
- Prior documented hysterectomy and bilateral
salpingo-oophorectomy
- At least 55 years of age with prior hysterectomy with
or without
oophorectomy
- Age 35 to 54 with a prior hysterectomy
without oophorectomy OR
with a status of ovaries unknown with
documented follicle-stimulating
hormone level demonstrating elevation in
postmenopausal range
- Histologically confirmed lobular carcinoma in situ treated by local
excision
only OR at least 1.66% probability of invasive breast cancer within 5
years
using Breast Cancer Risk Assessment Profile
- No clinical evidence of malignancy on physical exam within the past 180 days
- No evidence of suspicious or malignant disease on bilateral mammogram
within
the past year
- No bilateral or unilateral prophylactic mastectomy
- No prior invasive breast cancer or intraductal carcinoma in situ
- Hormone receptor status:
Prior/Concurrent Therapy:
Biologic therapy: Chemotherapy: Endocrine therapy: - At least 3 months since prior estrogen or progesterone
replacement therapy, oral contraceptives, androgens, luteinizing hormone-releasing
hormone analogs, prolactin inhibitors, or antiandrogens
- At least 3 months since prior tamoxifen, raloxifene, or other
selective estrogen-receptor modulators of less than 3 months duration
- Concurrent Estring allowed
Radiotherapy: - No prior breast radiotherapy
Surgery: - See Disease Characteristics
Other: - No prior systemic adjuvant therapy for breast cancer
- No other participation in a cancer prevention or osteoporosis
prevention study involving pharmacologic intervention(s)
- NSABP-P-1 patients
who received placebo are eligible
- No concurrent warfarin or cholestyramine
- Concurrent calcitonin or nonhormonal medication (e.g., cholecalciferol, fluoride, or bisphosphonates) allowed
Patient Characteristics:
Age: Sex: Menopausal status: - See Disease Characteristics
Performance status: - No restricted normal activity for a significant portion of
each day
Life expectancy: Hematopoietic: - Granulocyte count at least 1,500/mm3
- Complete blood count and differential normal
- Platelet count
normal
Hepatic: - SGOT or SGPT normal
- Bilirubin normal
- Alkaline phosphatase
normal
Renal: Cardiovascular: - No cerebral vascular accident, transient ischemic attack,
atrial fibrillation, or uncontrolled hypertension
- No deep vein thrombosis
Pulmonary: Other: - No other prior malignancy within the past 5 years
except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No concurrent nonmalignant disease that would preclude
administration of tamoxifen or raloxifene
- No clinical depression, psychiatric condition, or addictive
disorder
- No uncontrolled diabetes
Expected Enrollment 19000Approximately 19,000 participants will be accrued for this study within 5 years. 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. Published ResultsVogel VG: The NSABP Study of Tamoxifen and Raloxifene (STAR) trial. Expert Rev Anticancer Ther 9 (1): 51-60, 2009.[PUBMED Abstract] Wickerham DL, Costantino JP, Vogel VG, et al.: The use of tamoxifen and raloxifene for the prevention of breast cancer. Recent Results Cancer Res 181: 113-9, 2009.[PUBMED Abstract] Ganz PA, Land SR, Wickerham DL, et al.: The Study of Tamoxifen and Raloxifene (STAR): Change in patient-reported outcomes (PROs) after the end of treatment. [Abstract] J Clin Oncol 25 (Suppl 18): A-1506, 2007. Ganz PA, Land SR, Wickerham DL, et al.: The study of tamoxifen and raloxifene (STAR): first report of patient-reported outcomes (PROs) from the NSABP P-2 breast cancer prevention study. [Abstract] J Clin Oncol 24 (Suppl 18): A-LBA561, 2006. Land SR, Wickerham DL, Costantino JP, et al.: Patient-reported symptoms and quality of life during treatment with tamoxifen or raloxifene for breast cancer prevention: the NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 trial. JAMA 295 (23): 2742-51, 2006.[PUBMED Abstract] Vogel VG, Costantino JP, Wickerham DL, et al.: The effects of tamoxifen versus raloxifene on the risk of developing noninvasive breast cancer in the NSABP study of tamoxifen and raloxifene (STAR) P-2 trial. [Abstract] Breast Cancer Res Treat 100 (Suppl 1): A-33, S16, 2006. Vogel VG, Costantino JP, Wickerham DL, et al.: Effects of tamoxifen vs raloxifene on the risk of developing invasive breast cancer and other disease outcomes: the NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 trial. JAMA 295 (23): 2727-41, 2006.[PUBMED Abstract] Related PublicationsCronin WM, Cecchini RS, Wickerham DL, et al.: Factors associated with participant adherence in the NSABP Study of Tamoxifen and Raloxifene (STAR). [Abstract] J Clin Oncol 26 (Suppl 15): A-6518, 2008. Land SR, Ritter MW, Costantino JP, et al.: Compliance with patient-reported outcomes in multicenter clinical trials: methodologic and practical approaches. J Clin Oncol 25 (32): 5113-20, 2007.[PUBMED Abstract] Gradishar WJ, Cella D: Selective estrogen receptor modulators and prevention of invasive breast cancer. JAMA 295 (23): 2784-6, 2006.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations National Surgical Adjuvant Breast and Bowel Project | | | Norman Wolmark, MD, Protocol chair | | Ph: 412-359-3336; 866-680-0004 |
| |
Related Information Web site for additional information 1
Registry Information | | Official Title | | Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer | | Trial Start Date | | 1999-05-26 | | Registered in ClinicalTrials.gov | | NCT00003906 2 | | Date Submitted to PDQ | | 1999-05-26 | | Information Last Verified | | 2006-06-07 | | NCI Grant/Contract Number | | CA12027 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
Table of Links
1 | http://www.nsabp.pitt.edu/STAR/Index.html |
2 | http://clinicaltrials.gov/ct/show/NCT00003906 |
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