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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
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Eli Lilly and Company
AstraZeneca
Information provided by (Responsible Party):
NSABP Foundation Inc

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date October 6, 2015
Study Start Date  ICMJE May 1999
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2010)
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:
  1. compared to tamoxifen, raloxifene significantly reduces the incidence rate of invasive breast cancer;
  2. compared to raloxifene, tamoxifen significantly reduces the incidence rate of invasive breast cancer; or
  3. the statistical superiority of one of the treatments cannot be demonstrated and the choice of therapy should be based on benefit/risk considerations.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00003906 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2010)
  • 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. ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer in Postmenopausal Women
Official Title  ICMJE Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer
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.

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 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Raloxifene
    60 mg/day plus placebo for 5 years
  • Drug: Tamoxifen
    20 mg/day plus placebo for 5 years
Study Arms  ICMJE
  • Active Comparator: Group 1
    Tamoxifen and placebo
    Intervention: Drug: Tamoxifen
  • Experimental: Group 2
    Raloxifene and Placebo
    Intervention: Drug: Raloxifene
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2009)
19747
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 a minimum projected 5 year probability of invasive breast cancer of at least 1.66%, 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:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 35 and over

Sex:

  • Female

Menopausal status:

  • See Disease Characteristics

Performance status:

  • No restricted normal activity for a significant portion of each day

Life expectancy:

  • At least 10 years

Hematopoietic:

  • Granulocyte count at least 1,500/mm^3
  • Complete blood count and differential normal
  • Platelet count normal

Hepatic:

  • SGOT or SGPT normal
  • Bilirubin normal
  • Alkaline phosphatase normal

Renal:

  • Creatinine normal

Cardiovascular:

  • No cerebral vascular accident, transient ischemic attack, atrial fibrillation, or uncontrolled hypertension
  • No deep vein thrombosis

Pulmonary:

  • No pulmonary embolus

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 35 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00003906
Other Study ID Numbers  ICMJE NSABP P-2
CDR0000067081
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NSABP Foundation Inc
Study Sponsor  ICMJE NSABP Foundation Inc
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Eli Lilly and Company
  • AstraZeneca
Investigators  ICMJE
Study Chair: Norman Wolmark, MD NSABP Foundation Inc
PRS Account NSABP Foundation Inc
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP