AzTrials
AzTrials

Breast CancerPhase 3NCT00003906

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

A Phase 3 study testing Raloxifene and Tamoxifen in people with Breast Cancer, run by NSABP Foundation Inc at 516 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 35 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Raloxifene and Tamoxifen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19,747 participants
Where
516 sitesin 3 countries
Study dates
May 1999to Aug 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

516 sites in 3 countries.

324 sites in 3 countries

United States300 sites

  • Hendrick Cancer Center

    Abilene, Texas, 79601-2316

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Hickman Cancer Center at Bixby Medical Center

    Adrian, Michigan, 49221

  • Akron General Medical Center

    Akron, Ohio, 44302

  • New York Oncology Hematology, P.C. - Albany Regional Cancer Center

    Albany, New York, 12208

  • Hematology-Oncology Associates, PC

    Albuquerque, New Mexico, 87102

  • Lovelace Medical Center at Lovelace Sandia Health System

    Albuquerque, New Mexico, 87108

  • New Mexico Oncology-Hematology Consultants, Limited

    Albuquerque, New Mexico, 87109

  • University of New Mexico Cancer Research and Treatment Center

    Albuquerque, New Mexico, 87131

  • Sacred Heart Hospital

    Allentown, Pennsylvania, 18102

  • John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103

  • Bon Secours-Holy Family Health System

    Altoona, Pennsylvania, 16602

  • Harrington Cancer Center

    Amarillo, Texas, 79106

  • McFarland Clinic, P.C.

    Ames, Iowa, 50010

  • Kaiser Permanente Medical Center - Anaheim/Orange County

    Anaheim, California, 92805

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99519-6604

  • AnMed Health

    Anderson, South Carolina, 29621

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0752

  • Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • Northwest Community Hospital

    Arlington Heights, Illinois, 60005

  • Mission Hospitals

    Asheville, North Carolina, 28801

  • King's Daughters Medical Center

    Ashland, Kentucky, 41101

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342-1701

  • JFK Medical Center

    Atlantis, Florida, 33462

  • Medical College of Georgia

    Augusta, Georgia, 30912

  • Rush Copley Medical Center

    Aurora, Illinois, 60504-4206

  • Kaiser Permanente Medical Center - Baldwin Park

    Baldwin Park, California, 91706

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Greater Baltimore Medical Center and Cancer Center

    Baltimore, Maryland, 21204

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • Franklin Square Hospital Center

    Baltimore, Maryland, 21237

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Ochsner Clinic of Baton Rouge

    Baton Rouge, Louisiana, 70809

  • Baton Rouge General Medical Center

    Baton Rouge, Louisiana, 70821-2511

  • Battle Creek Health System

    Battle Creek, Michigan, 49016

  • Bay Diagnostic Center for Women

    Bay City, Michigan, 48708

  • Julie and Ben Rogers Cancer Center

    Beaumont, Texas, 77701

  • Kaiser Permanente Medical Center - Bellflower

    Bellflower, California, 90706

  • St. Joseph Hospital Community Cancer Center

    Bellingham, Washington, 98225

  • St. Charles Medical Center

    Bend, Oregon, 97701

  • Green Mountain Oncology Group

    Bennington, Vermont, 05201

  • Southwestern Vermont Regional Cancer Center

    Bennington, Vermont, 05201

  • Alta Bates Comprehensive Cancer Center

    Berkeley, California, 94704

  • Mountainview Medical

    Berlin Corners, Vermont, 05602

  • Suburban Hospital

    Bethesda, Maryland, 20814

  • St. Luke's Hospital Cancer Center

    Bethlehem, Pennsylvania, 18015

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Coast Oncology/Hematology, P.L.L.C.

    Biloxi, Mississippi, 39530-4239

  • Quain & Ramstad Clinic

    Bismarck, North Dakota, 58501

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Cancer Research Center at Boston Medical Center

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Harvard Vanguard Medical Associates - Kenmore

    Boston, Massachusetts, 02215

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Providence Saint Joseph Medical Center - Burbank

    Burbank, California, 91505

  • Mills-Peninsula Health Services

    Burlingame, California, 94010

  • Lahey Clinic Medical Center - Burlington

    Burlington, Massachusetts, 01805

  • Vermont Cancer Center at University of Vermont

    Burlington, Vermont, 05401-3498

  • Cooper Cancer Institute

    Camden, New Jersey, 08103

  • Mercy Medical Center

    Canton, Ohio, 44708

  • Aultman Hospital Cancer Center at Aultman Health Foundation

    Canton, Ohio, 44710

  • CCOP - Cedar Rapids Oncology Project

    Cedar Rapids, Iowa, 52403-1206

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7295

  • Roper St. Francis Healthcare - Roper Hospital

    Charleston, South Carolina, 29401

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • David Lee Cancer Center at Charleston Area Medical Center

    Charleston, West Virginia, 25304-1297

  • Blumenthal Cancer Center at Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Presbyterian Healthcare

    Charlotte, North Carolina, 28233-3549

  • Martha Jefferson Hospital

    Charlottesville, Virginia, 22901

  • Saint Luke's Hospital

    Chesterfield, Missouri, 63017

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • MBCCOP - University of Illinois at Chicago

    Chicago, Illinois, 60612-7323

  • John H. Stroger, Jr. Hospital of Cook County

    Chicago, Illinois, 60612-9985

  • Rush Cancer Institute at Rush University Medical Center

    Chicago, Illinois, 60612

  • Resurrection Medical Center

    Chicago, Illinois, 60631

  • Our Lady of the Resurrection Medical Center

    Chicago, Illinois, 60634

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Creticos Cancer Center at Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Enloe Cancer Center at Enloe Medical Center

    Chico, California, 95926

  • Cancer Center at Christ Hospital

    Cincinnati, Ohio, 45219

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267-0502

  • Mid Delta Family Practice

    Cleveland, Mississippi, 38732

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • Fairview Hospital

    Cleveland, Ohio, 44111

  • Kaiser Permanente

    Cleveland, Ohio, 44120

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Medical Associates

    Clinton, Iowa, 52732-5031

  • North Idaho Cancer Center

    Coeur d'Alene, Idaho, 83814

  • Community Health Center of Branch County

    Coldwater, Michigan, 49036

  • Penrose Cancer Center

    Colorado Springs, Colorado, 80933

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • Palmetto Richland Memorial Hospital

    Columbia, South Carolina, 29203

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio, 43210-1240

  • Mount Diablo Medical Center

    Concord, California, 94524-4110

  • Louis Busch Hager Cancer Center at Mary Imogene Bassett Hospital

    Cooperstown, New York, 13326-1394

  • Corona Regional Medical Center

    Corona, California, 92882-3400

  • Jennie Edmundson Memorial Hospital

    Council Bluffs, Iowa, 51503

  • Presbyterian Hospital of Dallas

    Dallas, Texas, 75231

  • Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas

    Dallas, Texas, 75235-9154

  • Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Methodist Dallas Medical Center

    Dallas, Texas, 75265-5999

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-2001

  • Cancer Center of the Piedmont, Inc.

    Danville, Virginia, 24541

  • Danville Hematology and Oncology, Incorporated

    Danville, Virginia, 24541

  • Mercy Fitzgerald Hospital

    Darby, Pennsylvania, 19023

  • Genesis Regional Cancer Center at Genesis Medical Center

    Davenport, Iowa, 52803

  • Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • CCOP - Central Illinois

    Decatur, Illinois, 62526

  • CCOP - Colorado Cancer Research Program, Incorporated

    Denver, Colorado, 80209-5031

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309-1016

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • St. John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Doylestown Hospital

    Doylestown, Pennsylvania, 18901

  • Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • Wendt Regional Cancer Center of Finley Hospital

    Dubuque, Iowa, 52001

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • St. Luke's Medical Clinic

    Duluth, Minnesota, 55805

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Easton Hospital

    Easton, Pennsylvania, 18042

  • St. Elizabeth Medical Center

    Edgewood, Kentucky, 41017

  • Providence Memorial Hospital

    El Paso, Texas, 79902

  • Sherman Hospital

    Elgin, Illinois, 60120-2198

  • Scripps Memorial Hospitals-Stevens Cancer Center - Encinitas

    Encinitas, California, 92024

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • Ephrata Community Hopital

    Ephrata, Pennsylvania, 17522-1002

  • Regional Cancer Center - Erie

    Erie, Pennsylvania, 16505

  • CCOP - Evanston

    Evanston, Illinois, 60201

  • St. Francis Hospital

    Evanston, Illinois, 60202

  • Flynn Cancer Center at Providence Everett Medical Center - Pacific Campus

    Everett, Washington, 98258-0000

  • North Bay Cancer Center

    Fairfield, California, 94533

  • Saint Anne's Hospital

    Fall River, Massachusetts, 02721

  • CCOP - Merit Care Hospital

    Fargo, North Dakota, 58122

  • University of Connecticut Comprehensive Cancer Center at University of Connecticut Health Center

    Farmington, Connecticut, 06360-7106

  • Breast Associates

    Fayetteville, Arkansas, 72703

  • Cape Fear Valley Health System

    Fayetteville, North Carolina, 28302-2000

  • Blanchard Valley Medical Associates

    Findlay, Ohio, 45840

  • Hunterdon Regional Cancer Center

    Flemington, New Jersey, 08822

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Flint Hematology Oncology

    Flint, Michigan, 48532

  • McLeod Regional Medical Center

    Florence, South Carolina, 29501

  • Kaiser Permanente Medical Center - Fontana

    Fontana, California, 92335

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Surgical Associates

    Fort Smith, Arkansas, 72917

  • Harris Methodist Fort Worth

    Fort Worth, Texas, 76104

  • HCA Kings Daughters Memorial Hospital

    Frankfort, Kentucky, 40601

  • Frederick Memorial Hospital Regional Cancer Therapy Center

    Frederick, Maryland, 21701

  • Fremont Memorial Hospital

    Fremont, Ohio, 43420

  • Crosson Cancer Center at St. Jude Medical Center

    Fullerton, California, 92835

  • Gaston Hematology and Oncology

    Gastonia, North Carolina, 28054

  • Glendale Memorial Hospital Comprehensive Cancer Center

    Glendale, California, 91204

  • Charles R. Wood Foundation Cancer Center at Glens Falls Hospital

    Glens Falls, New York, 12801

  • Southeastern Medical Oncology Center

    Goldsboro, North Carolina, 27534

  • Center for Cancer Care at Goshen Health System

    Goshen, Indiana, 46526

  • Oncology/Hematology Associates

    Granada Hills, California, 91344

  • Genesys Regional Medical Center

    Grand Blanc, Michigan, 48439-8066

  • Saint Francis Medical Center

    Grand Island, Nebraska, 68802

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Montana Cancer Institute - Benefis Healthcare

    Great Falls, Montana, 59405

  • Marin General Hospital Cancer Institute

    Greenbrae, California, 94904

  • Moses Cone Regional Cancer Center at Wesley Long Community Hospital

    Greensboro, North Carolina, 27403-1199

  • Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina

    Greenville, North Carolina, 27858-4354

  • Cancer Centers of the Carolinas - Eastside

    Greenville, South Carolina, 29601

  • CCOP - Northern New Jersey

    Hackensack, New Jersey, 07601

  • Kaiser Permanente Medical Center - Harbor City

    Harbor City, California, 90710

  • Pinnacle Health Regional Cancer Center at Pinnacle Health System

    Harrisburg, Pennsylvania, 17105-8700

  • Hartford Hospital

    Hartford, Connecticut, 06102-5037

  • St. Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Hattiesburg Clinic, P.A.

    Hattiesburg, Mississippi, 39401

  • Mercy Community Hospital

    Havertown, Pennsylvania, 19083

  • Advocate South Suburban Hospital

    Hazel Crest, Illinois, 60429

  • Hemet Valley Medical Center

    Hemet, California, 92543

  • Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Penn State Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Cornerstone Surgery

    High Point, North Carolina, 27262

  • Evanston Northwestern Health Care - Highland Park Hospital

    Highland Park, Illinois, 60035-2497

  • Hinsdale Hematology Oncology Associates

    Hinsdale, Illinois, 60521

  • Holland Community Hospital

    Holland, Michigan, 49423

  • MBCCOP - Hawaii

    Honolulu, Hawaii, 96813

  • New Hampshire Oncology-Hematology, PA - Hooksett

    Hooksett, New Hampshire, 03106

  • Cancer Care Specialists

    Houma, Louisiana, 70360

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Texas Cancer Institute at St. Luke's Episcopal Hospital

    Houston, Texas, 77030

  • Comprehensive Cancer Institute

    Huntsville, Alabama, 35801

  • Cleveland Clinic Cancer Center

    Independence, Ohio, 44131

  • Indiana Community Cancer Care, Incorporated

    Indianapolis, Indiana, 46202

  • Methodist Cancer Center at Methodist Hospital

    Indianapolis, Indiana, 46206-1367

  • Indiana Regional Cancer Center

    Indianapolis, Indiana, 46256

  • St. Vincent Hospital and Health Care Center

    Indianapolis, Indiana, 46260

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1009

  • Baylor Medical Center at Garland

    Irving, Texas, 75061

  • Center for Hematology/Oncology

    Jackson, Michigan, 49201

  • Jackson Oncology Associates, PLLC

    Jackson, Mississippi, 39202

  • St. Vincent's Medical Center

    Jacksonville, Florida, 32203

  • Baptist Regional Cancer Institute - Jacksonville

    Jacksonville, Florida, 32207

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Queens Cancer Center of Queens Hospital

    Jamaica, New York, 11432

  • Joliet Oncology Hematology Associates, Limited - Joliet

    Joliet, Illinois, 60435

  • Northeast Arkansas Clinic

    Jonesboro, Arkansas, 72401

  • Freeman Cancer Institute at Freeman Health System

    Joplin, Missouri, 64803-2644

  • St. John's Regional Medical Center

    Joplin, Missouri, 64804

  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center

    Jupiter, Florida, 33458

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-3731

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

    Kansas City, Kansas, 66160-7357

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Cancer Center at the Good Samaritan Health Systems

    Kearney, Nebraska, 68848-1990

  • Keesler Medical Center - Keesler Air Force Base

    Keesler Air Force Base, Mississippi, 39534-2576

  • CCOP - Dayton

    Kettering, Ohio, 45429

  • Wellmont Holston Valley Hospital and Medical Center

    Kingsport, Tennessee, 37662

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • U.T. Cancer Institute at University of Tennessee Medical Center

    Knoxville, Tennessee, 37920-2911

  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • Wilford Hall Medical Center

    Lackland Air Force Base, Texas, 78236-5300

  • Oncology Institute of Greater Lafayette

    Lafayette, Indiana, 47904

  • Watson Clinic

    Lakeland, Florida, 33804-5000

  • Lakeland Regional Cancer Center at Lakeland Regional Medical Center

    Lakeland, Florida, 33804

  • Valley Tumor Medical Group

    Lancaster, California, 93534

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17604-3555

  • Saint Mary Regional Cancer Center

    Langhorne, Pennsylvania, 19047

  • Michigan State University Department of Surgery

    Lansing, Michigan, 48912

  • Lapeer Regional Hospital

    Lapeer, Michigan, 48446

  • Sanchez Cancer Center

    Laredo, Texas, 78041

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • New York Oncology Hematology, P.C. - Latham

    Latham, New York, 12110-0610

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Central Baptist Hospital

    Lexington, Kentucky, 40503

  • Markey Cancer Center at University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536-0093

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • Cancer Resource Center - Lincoln

    Lincoln, Nebraska, 68510-4844

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • St. Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Loma Linda University Cancer Institute at Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Todd Cancer Institute at Long Beach Memorial Medical Center

    Long Beach, California, 90801-1428

  • Pacific Shores Medical Group Comprehensive Hematology-Oncology Services - Long Beach

    Long Beach, California, 90813

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740-6395

  • Kaiser Permanente Medical Center - Los Angeles

    Los Angeles, California, 90027

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90033-0804

  • Cecilia Gonzalez De La Hoya Cancer Center at White Memorial Medical Center

    Los Angeles, California, 90033

  • Kaiser Foundation Hospital - West Los Angeles

    Los Angeles, California, 90034

  • St. Vincent Medical Center - Los Angeles

    Los Angeles, California, 90057-1901

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

  • Norton Healthcare Cancer Center

    Louisville, Kentucky, 40202-5070

  • James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

  • Baptist Hospital East - Louisville

    Louisville, Kentucky, 40207

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79410-1894

  • Southwest Cancer and Research Center at University Medical Center

    Lubbock, Texas, 79415

  • Memorial Health System of East Texas

    Lufkin, Texas, 75902

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • Manchester Memorial Hospital

    Manchester, Connecticut, 06040-4188

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • Marquette General Hospital

    Marquette, Michigan, 49855

  • CCOP - Marshfield Clinic Research Foundation

    Marshfield, Wisconsin, 54449

  • Mercy Cancer Center at Mercy Medical Center - North Iowa

    Mason City, Iowa, 50401

  • St. Luke's Hospital

    Maumee, Ohio, 43537

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • Riddle Memorial Hospital

    Media, Pennsylvania, 19063

  • Baptist Cancer Institute - Memphis at Baptist Memorial Hospital - Memphis

    Memphis, Tennessee, 38117

  • Midstate Medical Center

    Meriden, Connecticut, 06451

  • University of Miami Sylvester Cancer Center

    Miami, Florida, 33136

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • South Jersey Regional Cancer Center

    Millville, New Jersey, 08332

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53201-0342

  • Oncology Alliance, S.C.

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Minnesota Cooperative Group Program

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center - Minneapolis

    Minneapolis, Minnesota, 55415

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Mission Cancer Center at Mission Hospital

    Mission Viejo, California, 92691

  • MBCCOP - Gulf Coast

    Mobile, Alabama, 36688

  • Sutter Gould Medical Foundation

    Modesto, California, 95353

  • Mercy Memorial Hospital, Corporation

    Monroe, Michigan, 48161-0067

  • Community Cancer Care Specialist

    Mount Clemens, Michigan, 48043

  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital

    Mount Holly, New Jersey, 08060

  • Ball Memorial Hospital Cancer Center

    Muncie, Indiana, 47303-3499

  • Community Hospital

    Munster, Indiana, 46321

  • Muskogee Regional Medical Center

    Muskogee, Oklahoma, 74401

  • Edward Hospital Cancer Center

    Naperville, Illinois, 60540-7499

  • Southern New Hampshire Medical Center

    Nashua, New Hampshire, 03061

  • MBCCOP - Meharry Medical College - Nashville

    Nashville, Tennessee, 37208-3599

  • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

    Nashville, Tennessee, 37232-6838

  • New Britain General Hospital

    New Britain, Connecticut, 06050

  • Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Hospital of St. Raphael

    New Haven, Connecticut, 06511

  • Yale Comprehensive Cancer Center

    New Haven, Connecticut, 06520-8028

  • Lawrence and Memorial Hospital

    New London, Connecticut, 06320

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • Tulane Cancer Center at Tulane University Hospital and Clinic

    New Orleans, Louisiana, 70112

Other trials in United States

Canada23 sites

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • CHUS-Hopital Fleurimont

    Fleurimont, Quebec, J1H 5N4

  • Hopital Charles Lemoyne

    Greenfield Park, Quebec, J4V 2H1

  • Familial Oncology Program

    Kingston, Ontario, K7L 5P9

  • Credit Valley Hospital

    Mississauga, Ontario, L5M 2N1

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2L-4M1

  • Royal Victoria Hospital - Montreal

    Montreal, Quebec, H3A 1A1

  • Montreal General Hospital

    Montreal, Quebec, H3G 1A4

  • Ville Marie Breast Center

    Montreal, Quebec, H3G 1L5

  • Jewish General Hospital - Montreal

    Montreal, Quebec, H3T 1E2

  • North York General Hospital, Ontario

    North York, Ontario, M2E 1K1

  • Ottawa Regional Cancer Centre

    Ottawa, Ontario, K1H 1C4

  • Hopital du Saint-Sacrement, Quebec

    Québec, Quebec, G1S 4L8

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Centre Universitaire de Sante de L'Estrie

    Sherbrooke, Quebec, J1H 5N4

  • Northwestern Ontario Regional Cancer Care

    Thunder Bay, Ontario, P7A 7T1

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario, M4N 3M5

  • St. Michael's Hospital - Toronto

    Toronto, Ontario, M5B 1W8

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

  • Women's College Ambulatory Care Center, Sunnybrook and Women's College Health Science Center

    Toronto, Ontario, M5S 1B6

  • University Hospital - U.B.C. Site

    Vancouver, British Columbia, V6T 2B5

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Puerto Rico1 site

  • MBCCOP - San Juan

    San Juan, 00927-5800

Other trials in Puerto Rico

About this study

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

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.

Read the 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.

Conditions
Breast Cancer
Being tested
Raloxifene, Tamoxifen
Keywords
breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RaloxifeneDrug

    60 mg/day plus placebo for 5 years

  • TamoxifenDrug

    20 mg/day plus placebo for 5 years

Study groups in NCT00003906
Study groupRoleWhat they receive
Group 1Active comparatorTamoxifen and placebo
Receives: Drug: Tamoxifen
Group 2ExperimentalRaloxifene and Placebo
Receives: Drug: Raloxifene

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Time from randomization to the occurance of invasive breast cancer.

Secondary outcomes (6)

  1. Effect of the study therapies on the incidence of intraductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS).

    Measured: Time from randomization to the occurance of DCIS or LCIS.

  2. Effect of the study therapies on the incidence of endometrial cancer.

    Measured: Time from randomization to the occurance of endometrial cancer.

  3. Effect of the study therapies on the incidence of ischemic heart disease.

    Measured: Time from randomization to the occurance of ischimic heart disease.

  4. Effect of the study therapies on the incidence of fractures of the hip, spine, or Colles' fractures of the wrist.

    Measured: Time from randomization to the occurance of fractures of the hip, spine, or Colles' fractures of the wrist.

  5. Effect of the study therapies on the toxicity and side effects of each therapy.

    Measured: Incidences of protocol defined toxicities and side effects.

  6. Effect of the study therapies on participants' quality of life.

    Measured: pre-entry, every 6 months for 5 years, and then annual after 5 years following randomization.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startMay 1999
  3. Primary completionDec 2005
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
19,747 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003906
Sponsor's protocol ID
NSABP P-2
Other IDs
CDR0000067081
Status last verified
Oct 2015
First submitted
1 Nov 1999
Last updated
6 Oct 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Cronin 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, Julian TB, Cronin WM, Haile SR, Wolmark N, Ganz PA. Compliance with patient-reported outcomes in multicenter clinical trials: methodologic and practical approaches. J Clin Oncol. 2007 Nov 10;25(32):5113-20. doi: 10.1200/JCO.2007.12.1749.

    PubMed 17991930

  • Gradishar WJ, Cella D. Selective estrogen receptor modulators and prevention of invasive breast cancer. JAMA. 2006 Jun 21;295(23):2784-6. doi: 10.1001/jama.295.23.jed60037. Epub 2006 Jun 5. No abstract available.

    PubMed 16754726

  • Vogel VG. The NSABP Study of Tamoxifen and Raloxifene (STAR) trial. Expert Rev Anticancer Ther. 2009 Jan;9(1):51-60. doi: 10.1586/14737140.9.1.51.

    PubMed 19105706

  • Wickerham DL, Costantino JP, Vogel VG, Cronin WM, Cecchini RS, Ford LG, Wolmark N. The use of tamoxifen and raloxifene for the prevention of breast cancer. Recent Results Cancer Res. 2009;181:113-9. doi: 10.1007/978-3-540-69297-3_12.

    PubMed 19213563

  • 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, Ritter MW, Vogel VG, Lee M, Pajon ER, Wade JL 3rd, Dakhil S, Lockhart JB Jr, Wolmark N, Ganz PA. 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. 2006 Jun 21;295(23):2742-51. doi: 10.1001/jama.295.23.joc60075. Epub 2006 Jun 5.

    PubMed 16754728

  • 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, Cronin WM, Cecchini RS, Atkins JN, Bevers TB, Fehrenbacher L, Pajon ER Jr, Wade JL 3rd, Robidoux A, Margolese RG, James J, Lippman SM, Runowicz CD, Ganz PA, Reis SE, McCaskill-Stevens W, Ford LG, Jordan VC, Wolmark N; National Surgical Adjuvant Breast and Bowel Project (NSABP). 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. 2006 Jun 21;295(23):2727-41. doi: 10.1001/jama.295.23.joc60074. Epub 2006 Jun 5.

    PubMed 16754727

  • McCaskill-Stevens W, Wilson JW, Cook ED, Edwards CL, Gibson RV, McElwain DL, Figueroa-Moseley CD, Paskett ED, Roberson NL, Wickerham DL, Wolmark N. National Surgical Adjuvant Breast and Bowel Project Study of Tamoxifen and Raloxifene trial: advancing the science of recruitment and breast cancer risk assessment in minority communities. Clin Trials. 2013 Apr;10(2):280-91. doi: 10.1177/1740774512470315. Epub 2013 Jan 18.

    PubMed 23335675

  • Cecchini RS, Costantino JP, Cauley JA, Cronin WM, Wickerham DL, Land SR, Weissfeld JL, Wolmark N. Body mass index and the risk for developing invasive breast cancer among high-risk women in NSABP P-1 and STAR breast cancer prevention trials. Cancer Prev Res (Phila). 2012 Apr;5(4):583-92. doi: 10.1158/1940-6207.CAPR-11-0482. Epub 2012 Feb 7.

    PubMed 22318751

  • Goetz MP, Schaid DJ, Wickerham DL, Safgren S, Mushiroda T, Kubo M, Batzler A, Costantino JP, Vogel VG, Paik S, Carlson EE, Flockhart DA, Wolmark N, Nakamura Y, Weinshilboum RM, Ingle JN, Ames MM. Evaluation of CYP2D6 and efficacy of tamoxifen and raloxifene in women treated for breast cancer chemoprevention: results from the NSABP P1 and P2 clinical trials. Clin Cancer Res. 2011 Nov 1;17(21):6944-51. doi: 10.1158/1078-0432.CCR-11-0860. Epub 2011 Aug 31.

    PubMed 21880792

  • Vogel VG, Costantino JP, Wickerham DL, Cronin WM, Cecchini RS, Atkins JN, Bevers TB, Fehrenbacher L, Pajon ER, Wade JL 3rd, Robidoux A, Margolese RG, James J, Runowicz CD, Ganz PA, Reis SE, McCaskill-Stevens W, Ford LG, Jordan VC, Wolmark N; National Surgical Adjuvant Breast and Bowel Project. Update of the National Surgical Adjuvant Breast and Bowel Project Study of Tamoxifen and Raloxifene (STAR) P-2 Trial: Preventing breast cancer. Cancer Prev Res (Phila). 2010 Jun;3(6):696-706. doi: 10.1158/1940-6207.CAPR-10-0076. Epub 2010 Apr 19.

    PubMed 20404000

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Raloxifene and Tamoxifen in people with Breast Cancer, run by NSABP Foundation Inc at 516 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 516 sites in United States, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of invasive breast cancer; superiority of one of the therapies. (time frame: Time from randomization to the occurance of invasive breast cancer.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003906, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2015.

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