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Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer

Phase 3
35 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer


- 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

- 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

Participants are followed annually after 5 years.

PROJECTED ACCRUAL: Approximately 19,000 participants will be accrued for this study within 5

Inclusion Criteria


- 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

- No bilateral or unilateral prophylactic mastectomy

- No prior invasive breast cancer or intraductal carcinoma in situ

- Hormone receptor status:

- Not specified



- 35 and over


- 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


- Granulocyte count at least 1,500/mm^3

- Complete blood count and differential normal

- Platelet count normal


- SGOT or SGPT normal

- Bilirubin normal

- Alkaline phosphatase normal


- Creatinine normal


- No cerebral vascular accident, transient ischemic attack, atrial fibrillation, or
uncontrolled hypertension

- No deep vein thrombosis


- No pulmonary embolus


- 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

- No clinical depression, psychiatric condition, or addictive disorder

- No uncontrolled diabetes


Biologic therapy:

- Not specified


- 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


- No prior breast radiotherapy


- See Disease Characteristics


- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Incidence of invasive breast cancer; superiority of one of the therapies.

Outcome Description:

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.

Outcome Time Frame:

Time from randomization to the occurance of invasive breast cancer.

Safety Issue:


Principal Investigator

Norman Wolmark, MD

Investigator Role:

Study Chair

Investigator Affiliation:

NSABP Foundation, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

May 1999

Completion Date:

August 2012

Related Keywords:

  • Breast Cancer
  • breast cancer
  • Breast Neoplasms



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McFarland Clinic, P.C.Ames, Iowa  50010
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Cancer Resource Center - LincolnLincoln, Nebraska  68510
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Hemet Valley Medical CenterHemet, California  92543
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Kaiser Foundation Hospital - West Los AngelesLos Angeles, California  90034
Mission Cancer Center at Mission HospitalMission Viejo, California  92691
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Wilshire Oncology Medical Group, Incorporated - PomonaPomona, California  91767-3021
North Valley Breast ClinicRedding, California  96001
Kaiser Permanente Medical Center - RiversideRiverside, California  92505
Sutter Roseville Medical CenterRoseville, California  95661
Santa Clarita Valley Cancer Center - UCLAValencia, California  91355
Kaiser Permanente Medical Cener - Woodland HillsWoodland Hills, California  91365-4084
Manchester Memorial HospitalManchester, Connecticut  06040-4188
Midstate Medical CenterMeriden, Connecticut  06451
Hematology Oncology, P.C.Stamford, Connecticut  06902
Windham Community Memorial HospitalWilliamantic, Connecticut  06226
Nanticoke Memorial HospitalSeaford, Delaware  19973
Providence HospitalWashington, District of Columbia  20017
Washington Hospital CenterWashington, District of Columbia  20010
JFK Medical CenterAtlantis, Florida  33462
St. Vincent's Medical CenterJacksonville, Florida  32203
Florida Hospital Medical CenterOrlando, Florida  32803-1273
West Florida Regional Medical CenterPensacola, Florida  32514-6088
Cancer Research Network Inc.Plantation, Florida  33324
Clinical Research Center of South FloridaStuart, Florida  34996
Medical College of GeorgiaAugusta, Georgia  30912
Cancer Care and Research Pavilion at St. Joseph's/CandlerSavannah, Georgia  31405-6013
Rush Copley Medical CenterAurora, Illinois  60504-4206
Our Lady of the Resurrection Medical CenterChicago, Illinois  60634
Rush Cancer Institute at Rush University Medical CenterChicago, Illinois  60612
Resurrection Medical CenterChicago, Illinois  60631
Sherman HospitalElgin, Illinois  60120-2198
St. Francis HospitalEvanston, Illinois  60202
Advocate South Suburban HospitalHazel Crest, Illinois  60429
Evanston Northwestern Health Care - Highland Park HospitalHighland Park, Illinois  60035-2497
Joliet Oncology Hematology Associates, Limited - JolietJoliet, Illinois  60435
Mid-Illinois Hematology-Oncology AssociatesNormal, Illinois  61761
Saint James Hospital and Health Centers Comprehensive Cancer InstituteOlympia Fields, Illinois  60461
Trinity Medical Center - WestRock Island, Illinois  61201
Memorial Medical CenterSpringfield, Illinois  62781
Center for Cancer Care at Goshen Health SystemGoshen, Indiana  46526
Indiana Regional Cancer CenterIndianapolis, Indiana  46256
Indiana Community Cancer Care, IncorporatedIndianapolis, Indiana  46202
Medical AssociatesClinton, Iowa  52732-5031
Jennie Edmundson Memorial HospitalCouncil Bluffs, Iowa  51503
Cedar Valley Medical Specialists, P.C.Waterloo, Iowa  50701
King's Daughters Medical CenterAshland, Kentucky  41101
HCA Kings Daughters Memorial HospitalFrankfort, Kentucky  40601
Cancer Care SpecialistsHouma, Louisiana  70360
Cancer Treatment Center at Christus Schumpert St. Mary PlaceShreveport, Louisiana  71101
Goodall HospitalSanford, Maine  04073
Frederick Memorial Hospital Regional Cancer Therapy CenterFrederick, Maryland  21701
Harvard Vanguard Medical Associates - KenmoreBoston, Massachusetts  02215
Saint Anne's HospitalFall River, Massachusetts  02721
Berkshire Physicians and Surgeons, P.C.Pittsfield, Massachusetts  01201
Jordan Hospital Club Cancer CenterPlymouth, Massachusetts  02360
Bay Diagnostic Center for WomenBay City, Michigan  48708
Community Health Center of Branch CountyColdwater, Michigan  49036
Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Flint Hematology OncologyFlint, Michigan  48532
Center for Hematology/OncologyJackson, Michigan  49201
Michigan State University Department of SurgeryLansing, Michigan  48912
Lapeer Regional HospitalLapeer, Michigan  48446
Mercy Memorial Hospital, CorporationMonroe, Michigan  48161-0067
Community Cancer Care SpecialistMount Clemens, Michigan  48043
Memorial HealthcareOwosso, Michigan  48867
Blue Water Oncology PC, Port HuronPort Huron, Michigan  48060
Saint Mary's Seton Cancer InstituteSaginaw, Michigan  48601
St. Luke's Medical ClinicDuluth, Minnesota  55805
Minnesota Cooperative Group ProgramMinneapolis, Minnesota  55407
Coast Oncology/Hematology, P.L.L.C.Biloxi, Mississippi  39530-4239
Mid Delta Family PracticeCleveland, Mississippi  38732
Jackson Oncology Associates, PLLCJackson, Mississippi  39202
North Mississippi Hematology and Oncology Associates, LimitedTupelo, Mississippi  38801
St. John's Regional Medical CenterJoplin, Missouri  64804
Freeman Cancer Institute at Freeman Health SystemJoplin, Missouri  64803-2644
Phelps County Regional Medical CenterRolla, Missouri  65401
Midwest Hematology Oncology Group, Inc.Saint Louis, Missouri  63109
Missouri Cancer Care, P.C. - St. CharlesSt. Charles, Missouri  63301
Ozarks Medical CenterWest Plains, Missouri  65775
Montana Cancer Institute - Benefis HealthcareGreat Falls, Montana  59405
Saint Francis Medical CenterGrand Island, Nebraska  68802
Englewood Hospital and Medical CenterEnglewood, New Jersey  07631
Underwood Memorial HospitalWoodbury, New Jersey  08096
New Mexico Oncology-Hematology Consultants, LimitedAlbuquerque, New Mexico  87109
New Mexico Cancer Care AssociatesSanta Fe, New Mexico  87505-7670
New York Oncology Hematology, P.C. - LathamLatham, New York  12110-0610
St. Francis Hospital and Health CentersPoughkeepsie, New York  12601
Gynecologic Oncology AssociatesRochester, New York  14620
University Hospital - Stony BrookStony Brook, New York  11794-8174
Gaston Hematology and OncologyGastonia, North Carolina  28054
Southeastern Medical Oncology CenterGoldsboro, North Carolina  27534
Cornerstone SurgeryHigh Point, North Carolina  27262
Raleigh Hematology/Oncology Associates, P.A. - Rex Cancer CenterRaleigh, North Carolina  27607
Cancer Center at Iredell Memorial HospitalStatesville, North Carolina  28687-1828
Forsyth Medical CenterWinston-Salem, North Carolina  27103
Quain & Ramstad ClinicBismarck, North Dakota  58501
Kaiser PermanenteCleveland, Ohio  44120
Fairview HospitalCleveland, Ohio  44111
Cleveland Clinic Health System STAR BCPTWarrensville Heights, Ohio  44122
Muskogee Regional Medical CenterMuskogee, Oklahoma  74401
Frank C. Love Cancer Institute at St. Anthony HospitalOklahoma City, Oklahoma  73101
Mercy Health CenterOklahoma City, Oklahoma  73120
Central Oklahoma Cancer Center at INTEGRIS Southwest Medical CenterOklahoma City, Oklahoma  73109
St. Charles Medical CenterBend, Oregon  97701
Bon Secours-Holy Family Health SystemAltoona, Pennsylvania  16602
Doylestown HospitalDoylestown, Pennsylvania  18901
Ephrata Community HopitalEphrata, Pennsylvania  17522-1002
Pinnacle Health Regional Cancer Center at Pinnacle Health SystemHarrisburg, Pennsylvania  17105-8700
Mercy Community HospitalHavertown, Pennsylvania  19083
Saint Mary Regional Cancer CenterLanghorne, Pennsylvania  19047
Riddle Memorial HospitalMedia, Pennsylvania  19063
Mercy Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19143
Chestnut Hill HealthcarePhiladelphia, Pennsylvania  19118
Frankford HospitalPhiladelphia, Pennsylvania  19114
Pennsylvania Oncology Hematology AssociatesPhiladelphia, Pennsylvania  19107
Crozer-Chester Medical CenterUpland, Pennsylvania  19013
AnMed HealthAnderson, South Carolina  29621
Roper St. Francis Healthcare - Roper HospitalCharleston, South Carolina  29401
McLeod Regional Medical CenterFlorence, South Carolina  29501
Cancer Centers of the Carolinas - EastsideGreenville, South Carolina  29601
Wellmont Holston Valley Hospital and Medical CenterKingsport, Tennessee  37662
U.T. Cancer Institute at University of Tennessee Medical CenterKnoxville, Tennessee  37920-2911
MBCCOP - Meharry Medical College - NashvilleNashville, Tennessee  37208-3599
Hendrick Cancer CenterAbilene, Texas  79601-2316
Julie and Ben Rogers Cancer CenterBeaumont, Texas  77701
Methodist Dallas Medical CenterDallas, Texas  75265-5999
Presbyterian Hospital of DallasDallas, Texas  75231
Providence Memorial HospitalEl Paso, Texas  79902
Harris Methodist Fort WorthFort Worth, Texas  76104
Texas Cancer Institute at St. Luke's Episcopal HospitalHouston, Texas  77030
Baylor Medical Center at GarlandIrving, Texas  75061
Sanchez Cancer CenterLaredo, Texas  78041
Memorial Health System of East TexasLufkin, Texas  75902
Baylor/Richardson Cancer CenterRichardson, Texas  75080
Danville Hematology and Oncology, IncorporatedDanville, Virginia  24541
Cancer Center of the Piedmont, Inc.Danville, Virginia  24541
Henrico Doctors' Hospital - Parham CampusRichmond, Virginia  23229
Flynn Cancer Center at Providence Everett Medical Center - Pacific CampusEverett, Washington  98258-0000
Cancer Care Northwest - Spokane NorthSpokane, Washington  99207
Yakima Regional Cancer Care CenterYakima, Washington  89802
David Lee Cancer Center at Charleston Area Medical CenterCharleston, West Virginia  25304-1297
Oncology Alliance, S.C.Milwaukee, Wisconsin  53215