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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003906
• Other study ID #: NSABP P-2
• Secondary ID: CDR0000067081
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: October 5, 2015
• Start date: May 1999
• Est. completion date: August 2012

Study information

• Verified date: October 2015
• Source: NSABP Foundation Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Federal GovernmentUnited States: Institutional Review BoardCanada: Ethics Review CommitteeCanada: Health Canada
• Study type: Interventional

Clinical 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.

PURPOSE: Randomized double-blinded clinical trial to compare the effectiveness of raloxifene with that of tamoxifen in preventing breast cancer in postmenopausal women.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19747
• Est. completion date: August 2012
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Raloxifene
60 mg/day plus placebo for 5 years
• Tamoxifen
20 mg/day plus placebo for 5 years

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Center - Calgary	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	CHUS-Hopital Fleurimont	Fleurimont	Quebec
Canada	Hopital Charles Lemoyne	Greenfield Park	Quebec
Canada	Familial Oncology Program	Kingston	Ontario
Canada	Credit Valley Hospital	Mississauga	Ontario
Canada	Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec
Canada	Jewish General Hospital - Montreal	Montreal	Quebec
Canada	Montreal General Hospital	Montreal	Quebec
Canada	Royal Victoria Hospital - Montreal	Montreal	Quebec
Canada	Ville Marie Breast Center	Montreal	Quebec
Canada	North York General Hospital, Ontario	North York	Ontario
Canada	Ottawa Regional Cancer Centre	Ottawa	Ontario
Canada	Hopital du Saint-Sacrement, Quebec	Quebec City	Quebec
Canada	Saskatoon Cancer Centre	Saskatoon	Saskatchewan
Canada	Centre Universitaire de Sante de L'Estrie	Sherbrooke	Quebec
Canada	Northwestern Ontario Regional Cancer Care	Thunder Bay	Ontario
Canada	St. Michael's Hospital - Toronto	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Toronto Sunnybrook Regional Cancer Centre	Toronto	Ontario
Canada	Women's College Ambulatory Care Center, Sunnybrook and Women's College Health Science Center	Toronto	Ontario
Canada	University Hospital - U.B.C. Site	Vancouver	British Columbia
Canada	CancerCare Manitoba	Winnipeg	Manitoba
Puerto Rico	MBCCOP - San Juan	San Juan
United States	Hendrick Cancer Center	Abilene	Texas
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan
United States	Akron General Medical Center	Akron	Ohio
United States	New York Oncology Hematology, P.C. - Albany Regional Cancer Center	Albany	New York
United States	Hematology-Oncology Associates, PC	Albuquerque	New Mexico
United States	Lovelace Medical Center at Lovelace Sandia Health System	Albuquerque	New Mexico
United States	New Mexico Oncology-Hematology Consultants, Limited	Albuquerque	New Mexico
United States	University of New Mexico Cancer Research and Treatment Center	Albuquerque	New Mexico
United States	John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Sacred Heart Hospital	Allentown	Pennsylvania
United States	Bon Secours-Holy Family Health System	Altoona	Pennsylvania
United States	Harrington Cancer Center	Amarillo	Texas
United States	McFarland Clinic, P.C.	Ames	Iowa
United States	Kaiser Permanente Medical Center - Anaheim/Orange County	Anaheim	California
United States	Providence Alaska Medical Center	Anchorage	Alaska
United States	AnMed Health	Anderson	South Carolina
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Anne Arundel Medical Center	Annapolis	Maryland
United States	Northwest Community Hospital	Arlington Heights	Illinois
United States	Mission Hospitals	Asheville	North Carolina
United States	King's Daughters Medical Center	Ashland	Kentucky
United States	CCOP - Atlanta Regional	Atlanta	Georgia
United States	JFK Medical Center	Atlantis	Florida
United States	Medical College of Georgia	Augusta	Georgia
United States	Rush Copley Medical Center	Aurora	Illinois
United States	Kaiser Permanente Medical Center - Baldwin Park	Baldwin Park	California
United States	Franklin Square Hospital Center	Baltimore	Maryland
United States	Greater Baltimore Medical Center and Cancer Center	Baltimore	Maryland
United States	Greenebaum Cancer Center at University of Maryland Medical Center	Baltimore	Maryland
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Eastern Maine Medical Center	Bangor	Maine
United States	Baton Rouge General Medical Center	Baton Rouge	Louisiana
United States	Ochsner Clinic of Baton Rouge	Baton Rouge	Louisiana
United States	Battle Creek Health System	Battle Creek	Michigan
United States	Bay Diagnostic Center for Women	Bay City	Michigan
United States	Julie and Ben Rogers Cancer Center	Beaumont	Texas
United States	Kaiser Permanente Medical Center - Bellflower	Bellflower	California
United States	St. Joseph Hospital Community Cancer Center	Bellingham	Washington
United States	St. Charles Medical Center	Bend	Oregon
United States	Green Mountain Oncology Group	Bennington	Vermont
United States	Southwestern Vermont Regional Cancer Center	Bennington	Vermont
United States	Alta Bates Comprehensive Cancer Center	Berkeley	California
United States	Mountainview Medical	Berlin	Vermont
United States	Suburban Hospital	Bethesda	Maryland
United States	St. Luke's Hospital Cancer Center	Bethlehem	Pennsylvania
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	Coast Oncology/Hematology, P.L.L.C.	Biloxi	Mississippi
United States	Quain & Ramstad Clinic	Bismarck	North Dakota
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Cancer Research Center at Boston Medical Center	Boston	Massachusetts
United States	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts
United States	Harvard Vanguard Medical Associates - Kenmore	Boston	Massachusetts
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Olympic Hematology and Oncology	Bremerton	Washington
United States	Albert Einstein Clinical Cancer Center	Bronx	New York
United States	Comprehensive Cancer Center at Our Lady of Mercy Medical Center	Bronx	New York
United States	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Providence Saint Joseph Medical Center - Burbank	Burbank	California
United States	Mills-Peninsula Health Services	Burlingame	California
United States	Lahey Clinic Medical Center - Burlington	Burlington	Massachusetts
United States	Vermont Cancer Center at University of Vermont	Burlington	Vermont
United States	Cooper Cancer Institute	Camden	New Jersey
United States	Aultman Hospital Cancer Center at Aultman Health Foundation	Canton	Ohio
United States	Mercy Medical Center	Canton	Ohio
United States	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	David Lee Cancer Center at Charleston Area Medical Center	Charleston	West Virginia
United States	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina
United States	Roper St. Francis Healthcare - Roper Hospital	Charleston	South Carolina
United States	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina
United States	Presbyterian Healthcare	Charlotte	North Carolina
United States	Martha Jefferson Hospital	Charlottesville	Virginia
United States	Saint Luke's Hospital	Chesterfield	Missouri
United States	Creticos Cancer Center at Advocate Illinois Masonic Medical Center	Chicago	Illinois
United States	John H. Stroger, Jr. Hospital of Cook County	Chicago	Illinois
United States	MBCCOP - University of Illinois at Chicago	Chicago	Illinois
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Our Lady of the Resurrection Medical Center	Chicago	Illinois
United States	Resurrection Medical Center	Chicago	Illinois
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois
United States	Rush Cancer Institute at Rush University Medical Center	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Enloe Cancer Center at Enloe Medical Center	Chico	California
United States	Bethesda North Hospital	Cincinnati	Ohio
United States	Cancer Center at Christ Hospital	Cincinnati	Ohio
United States	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Fairview Hospital	Cleveland	Ohio
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Kaiser Permanente	Cleveland	Ohio
United States	Mid Delta Family Practice	Cleveland	Mississippi
United States	Medical Associates	Clinton	Iowa
United States	North Idaho Cancer Center	Coeur d'Alene	Idaho
United States	Community Health Center of Branch County	Coldwater	Michigan
United States	Penrose Cancer Center	Colorado Springs	Colorado
United States	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri
United States	Palmetto Richland Memorial Hospital	Columbia	South Carolina
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	CCOP - Columbus	Columbus	Ohio
United States	Mount Diablo Medical Center	Concord	California
United States	Louis Busch Hager Cancer Center at Mary Imogene Bassett Hospital	Cooperstown	New York
United States	Corona Regional Medical Center	Corona	California
United States	Jennie Edmundson Memorial Hospital	Council Bluffs	Iowa
United States	Charles A. Sammons Cancer Center	Dallas	Texas
United States	Methodist Dallas Medical Center	Dallas	Texas
United States	Presbyterian Hospital of Dallas	Dallas	Texas
United States	Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas
United States	Cancer Center of the Piedmont, Inc.	Danville	Virginia
United States	Danville Hematology and Oncology, Incorporated	Danville	Virginia
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Mercy Fitzgerald Hospital	Darby	Pennsylvania
United States	Genesis Regional Cancer Center at Genesis Medical Center	Davenport	Iowa
United States	Oakwood Hospital and Medical Center	Dearborn	Michigan
United States	CCOP - Central Illinois	Decatur	Illinois
United States	CCOP - Colorado Cancer Research Program, Incorporated	Denver	Colorado
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan
United States	St. John Hospital and Medical Center	Detroit	Michigan
United States	Doylestown Hospital	Doylestown	Pennsylvania
United States	Delaware County Memorial Hospital	Drexel Hill	Pennsylvania
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	Wendt Regional Cancer Center of Finley Hospital	Dubuque	Iowa
United States	CCOP - Duluth	Duluth	Minnesota
United States	St. Luke's Medical Clinic	Duluth	Minnesota
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Easton Hospital	Easton	Pennsylvania
United States	St. Elizabeth Medical Center	Edgewood	Kentucky
United States	Providence Memorial Hospital	El Paso	Texas
United States	Sherman Hospital	Elgin	Illinois
United States	Scripps Memorial Hospitals-Stevens Cancer Center - Encinitas	Encinitas	California
United States	Englewood Hospital and Medical Center	Englewood	New Jersey
United States	Ephrata Community Hopital	Ephrata	Pennsylvania
United States	Regional Cancer Center - Erie	Erie	Pennsylvania
United States	CCOP - Evanston	Evanston	Illinois
United States	St. Francis Hospital	Evanston	Illinois
United States	Flynn Cancer Center at Providence Everett Medical Center - Pacific Campus	Everett	Washington
United States	North Bay Cancer Center	Fairfield	California
United States	Saint Anne's Hospital	Fall River	Massachusetts
United States	CCOP - Merit Care Hospital	Fargo	North Dakota
United States	University of Connecticut Comprehensive Cancer Center at University of Connecticut Health Center	Farmington	Connecticut
United States	Breast Associates	Fayetteville	Arkansas
United States	Cape Fear Valley Health System	Fayetteville	North Carolina
United States	Blanchard Valley Medical Associates	Findlay	Ohio
United States	Hunterdon Regional Cancer Center	Flemington	New Jersey
United States	Flint Hematology Oncology	Flint	Michigan
United States	Hurley Medical Center	Flint	Michigan
United States	McLeod Regional Medical Center	Florence	South Carolina
United States	Kaiser Permanente Medical Center - Fontana	Fontana	California
United States	Poudre Valley Hospital	Fort Collins	Colorado
United States	Surgical Associates	Fort Smith	Arkansas
United States	Harris Methodist Fort Worth	Fort Worth	Texas
United States	HCA Kings Daughters Memorial Hospital	Frankfort	Kentucky
United States	Frederick Memorial Hospital Regional Cancer Therapy Center	Frederick	Maryland
United States	Fremont Memorial Hospital	Fremont	Ohio
United States	Crosson Cancer Center at St. Jude Medical Center	Fullerton	California
United States	Gaston Hematology and Oncology	Gastonia	North Carolina
United States	Glendale Memorial Hospital Comprehensive Cancer Center	Glendale	California
United States	Charles R. Wood Foundation Cancer Center at Glens Falls Hospital	Glens Falls	New York
United States	Southeastern Medical Oncology Center	Goldsboro	North Carolina
United States	Center for Cancer Care at Goshen Health System	Goshen	Indiana
United States	Oncology/Hematology Associates	Granada Hills	California
United States	Genesys Regional Medical Center	Grand Blanc	Michigan
United States	Saint Francis Medical Center	Grand Island	Nebraska
United States	CCOP - Grand Rapids	Grand Rapids	Michigan
United States	Montana Cancer Institute - Benefis Healthcare	Great Falls	Montana
United States	Marin General Hospital Cancer Institute	Greenbrae	California
United States	Moses Cone Regional Cancer Center at Wesley Long Community Hospital	Greensboro	North Carolina
United States	Cancer Centers of the Carolinas - Eastside	Greenville	South Carolina
United States	Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina	Greenville	North Carolina
United States	CCOP - Northern New Jersey	Hackensack	New Jersey
United States	Kaiser Permanente Medical Center - Harbor City	Harbor City	California
United States	Pinnacle Health Regional Cancer Center at Pinnacle Health System	Harrisburg	Pennsylvania
United States	Hartford Hospital	Hartford	Connecticut
United States	St. Francis Hospital and Medical Center	Hartford	Connecticut
United States	Ingalls Memorial Hospital	Harvey	Illinois
United States	Hattiesburg Clinic, P.A.	Hattiesburg	Mississippi
United States	Mercy Community Hospital	Havertown	Pennsylvania
United States	Advocate South Suburban Hospital	Hazel Crest	Illinois
United States	Hemet Valley Medical Center	Hemet	California
United States	Pardee Memorial Hospital	Hendersonville	North Carolina
United States	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Cornerstone Surgery	High Point	North Carolina
United States	Evanston Northwestern Health Care - Highland Park Hospital	Highland Park	Illinois
United States	Hinsdale Hematology Oncology Associates	Hinsdale	Illinois
United States	Holland Community Hospital	Holland	Michigan
United States	MBCCOP - Hawaii	Honolulu	Hawaii
United States	New Hampshire Oncology-Hematology, PA - Hooksett	Hooksett	New Hampshire
United States	Cancer Care Specialists	Houma	Louisiana
United States	Baylor College of Medicine	Houston	Texas
United States	Texas Cancer Institute at St. Luke's Episcopal Hospital	Houston	Texas
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Comprehensive Cancer Institute	Huntsville	Alabama
United States	Cleveland Clinic Cancer Center	Independence	Ohio
United States	Indiana Community Cancer Care, Incorporated	Indianapolis	Indiana
United States	Indiana Regional Cancer Center	Indianapolis	Indiana
United States	Methodist Cancer Center at Methodist Hospital	Indianapolis	Indiana
United States	St. Vincent Hospital and Health Care Center	Indianapolis	Indiana
United States	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa
United States	Baylor Medical Center at Garland	Irving	Texas
United States	Center for Hematology/Oncology	Jackson	Michigan
United States	Jackson Oncology Associates, PLLC	Jackson	Mississippi
United States	Baptist Regional Cancer Institute - Jacksonville	Jacksonville	Florida
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	St. Vincent's Medical Center	Jacksonville	Florida
United States	Queens Cancer Center of Queens Hospital	Jamaica	New York
United States	Joliet Oncology Hematology Associates, Limited - Joliet	Joliet	Illinois
United States	Northeast Arkansas Clinic	Jonesboro	Arkansas
United States	Freeman Cancer Institute at Freeman Health System	Joplin	Missouri
United States	St. John's Regional Medical Center	Joplin	Missouri
United States	Ella Milbank Foshay Cancer Center at Jupiter Medical Center	Jupiter	Florida
United States	CCOP - Kalamazoo	Kalamazoo	Michigan
United States	Kalispell Regional Medical Center	Kalispell	Montana
United States	CCOP - Kansas City	Kansas City	Missouri
United States	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Kansas City	Kansas
United States	Cancer Center at the Good Samaritan Health Systems	Kearney	Nebraska
United States	Keesler Medical Center - Keesler Air Force Base	Keesler AFB	Mississippi
United States	CCOP - Dayton	Kettering	Ohio
United States	Wellmont Holston Valley Hospital and Medical Center	Kingsport	Tennessee
United States	Thompson Cancer Survival Center	Knoxville	Tennessee
United States	U.T. Cancer Institute at University of Tennessee Medical Center	Knoxville	Tennessee
United States	Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center	La Crosse	Wisconsin
United States	Rebecca and John Moores UCSD Cancer Center	La Jolla	California
United States	Wilford Hall Medical Center	Lackland Air Force Base	Texas
United States	Oncology Institute of Greater Lafayette	Lafayette	Indiana
United States	Lakeland Regional Cancer Center at Lakeland Regional Medical Center	Lakeland	Florida
United States	Watson Clinic	Lakeland	Florida
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	Valley Tumor Medical Group	Lancaster	California
United States	Saint Mary Regional Cancer Center	Langhorne	Pennsylvania
United States	Michigan State University Department of Surgery	Lansing	Michigan
United States	Lapeer Regional Hospital	Lapeer	Michigan
United States	Sanchez Cancer Center	Laredo	Texas
United States	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	New York Oncology Hematology, P.C. - Latham	Latham	New York
United States	Beebe Medical Center	Lewes	Delaware
United States	Central Baptist Hospital	Lexington	Kentucky
United States	Markey Cancer Center at University of Kentucky Chandler Medical Center	Lexington	Kentucky
United States	Lima Memorial Hospital	Lima	Ohio
United States	Cancer Resource Center - Lincoln	Lincoln	Nebraska
United States	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	St. Barnabas Medical Center	Livingston	New Jersey
United States	Loma Linda University Cancer Institute at Loma Linda University Medical Center	Loma Linda	California
United States	Pacific Shores Medical Group Comprehensive Hematology-Oncology Services - Long Beach	Long Beach	California
United States	Todd Cancer Institute at Long Beach Memorial Medical Center	Long Beach	California
United States	Monmouth Medical Center	Long Branch	New Jersey
United States	Cecilia Gonzalez De La Hoya Cancer Center at White Memorial Medical Center	Los Angeles	California
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	Kaiser Foundation Hospital - West Los Angeles	Los Angeles	California
United States	Kaiser Permanente Medical Center - Los Angeles	Los Angeles	California
United States	St. Vincent Medical Center - Los Angeles	Los Angeles	California
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	Baptist Hospital East - Louisville	Louisville	Kentucky
United States	James Graham Brown Cancer Center at University of Louisville	Louisville	Kentucky
United States	Norton Healthcare Cancer Center	Louisville	Kentucky
United States	Joe Arrington Cancer Research and Treatment Center	Lubbock	Texas
United States	Southwest Cancer and Research Center at University Medical Center	Lubbock	Texas
United States	Memorial Health System of East Texas	Lufkin	Texas
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Manchester Memorial Hospital	Manchester	Connecticut
United States	CCOP - North Shore University Hospital	Manhasset	New York
United States	Marquette General Hospital	Marquette	Michigan
United States	CCOP - Marshfield Clinic Research Foundation	Marshfield	Wisconsin
United States	Mercy Cancer Center at Mercy Medical Center - North Iowa	Mason City	Iowa
United States	St. Luke's Hospital	Maumee	Ohio
United States	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois
United States	Riddle Memorial Hospital	Media	Pennsylvania
United States	Baptist Cancer Institute - Memphis at Baptist Memorial Hospital - Memphis	Memphis	Tennessee
United States	Midstate Medical Center	Meriden	Connecticut
United States	University of Miami Sylvester Cancer Center	Miami	Florida
United States	CCOP - Mount Sinai Medical Center	Miami Beach	Florida
United States	Saint Anthony Memorial Health Centers	Michigan City	Indiana
United States	South Jersey Regional Cancer Center	Millville	New Jersey
United States	Aurora Sinai Medical Center	Milwaukee	Wisconsin
United States	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	Oncology Alliance, S.C.	Milwaukee	Wisconsin
United States	Hennepin County Medical Center - Minneapolis	Minneapolis	Minnesota
United States	Minnesota Cooperative Group Program	Minneapolis	Minnesota
United States	University of Minnesota	Minneapolis	Minnesota
United States	Mission Cancer Center at Mission Hospital	Mission Viejo	California
United States	MBCCOP - Gulf Coast	Mobile	Alabama
United States	Sutter Gould Medical Foundation	Modesto	California
United States	Mercy Memorial Hospital, Corporation	Monroe	Michigan
United States	Community Cancer Care Specialist	Mount Clemens	Michigan
United States	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital	Mount Holly	New Jersey
United States	Ball Memorial Hospital Cancer Center	Muncie	Indiana
United States	Community Hospital	Munster	Indiana
United States	Muskogee Regional Medical Center	Muskogee	Oklahoma
United States	Edward Hospital Cancer Center	Naperville	Illinois
United States	Southern New Hampshire Medical Center	Nashua	New Hampshire
United States	MBCCOP - Meharry Medical College - Nashville	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center	Nashville	Tennessee
United States	New Britain General Hospital	New Britain	Connecticut
United States	Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Hospital of St. Raphael	New Haven	Connecticut
United States	Yale Comprehensive Cancer Center	New Haven	Connecticut
United States	Lawrence and Memorial Hospital	New London	Connecticut
United States	CCOP - Ochsner	New Orleans	Louisiana
United States	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana
United States	Tulane Cancer Center at Tulane University Hospital and Clinic	New Orleans	Louisiana
United States	Herbert Irving Comprehensive Cancer Center at Columbia University	New York	New York
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	NYU School of Medicine's Kaplan Comprehensive Cancer Center	New York	New York
United States	Saint Vincent Catholic Medical Center of New York	New York	New York
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Virginia Oncology Associates - Newport News	Newport News	Virginia
United States	Caritas Norwood Hospital	Norfolk	Massachusetts
United States	Mid-Illinois Hematology-Oncology Associates	Normal	Illinois
United States	Leavey Cancer Center at Northridge Hospital Medical Center	Northridge	California
United States	Eastern Connecticut Hematology and Oncology Associates	Norwich,	Connecticut
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	Breast Health Center	Oceanside	California
United States	Central Oklahoma Cancer Center at INTEGRIS Southwest Medical Center	Oklahoma City	Oklahoma
United States	Frank C. Love Cancer Institute at St. Anthony Hospital	Oklahoma City	Oklahoma
United States	Mercy Health Center	Oklahoma City	Oklahoma
United States	Oklahoma University Medical Center at University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Saint James Hospital and Health Centers Comprehensive Cancer Institute	Olympia Fields	Illinois
United States	Alegent Health - Immanuel Medical Center	Omaha	Nebraska
United States	Bergan Mercy Medical Center	Omaha	Nebraska
United States	Creighton University Medical Center	Omaha	Nebraska
United States	Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha	Omaha	Nebraska
United States	Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center	Orange	California
United States	St. Joseph Hospital Regional Cancer Center - Orange	Orange	California
United States	Florida Hospital Medical Center	Orlando	Florida
United States	MD Anderson Cancer Center Orlando	Orlando	Florida
United States	Ottumwa Regional Health Center	Ottumwa	Iowa
United States	Memorial Healthcare	Owosso	Michigan
United States	Ventura Hematology - Oncology Specialists - Oxnard	Oxnard	California
United States	Comprehensive Cancer Centers of the Desert	Palm Springs	California
United States	Palo Alto Medical Foundation	Palo Alto	California
United States	Kaiser Permanente Medical Group	Panorama City	California
United States	Cancer Center at Paoli Memorial Hospital	Paoli	Pennsylvania
United States	Lutheran General Cancer Care Center	Park Ridge	Illinois
United States	Camden-Clark Memorial Hospital	Parkersburg	West Virginia
United States	Parma Community General Hospital	Parma	Ohio
United States	Huntington Cancer Center at Huntington Hospital	Pasadena	California
United States	NSMC Cancer Center	Peabody	Massachusetts
United States	West Florida Regional Medical Center	Pensacola	Florida
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	Abramson Cancer Center at University of Pennsylvania Medical Center	Philadelphia	Pennsylvania
United States	Albert Einstein Cancer Center	Philadelphia	Pennsylvania
United States	Chestnut Hill Healthcare	Philadelphia	Pennsylvania
United States	Fox Chase - Temple Cancer Center	Philadelphia	Pennsylvania
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Frankford Hospital	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	Mercy Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Pennsylvania Oncology Hematology Associates	Philadelphia	Pennsylvania
United States	Warren Hospital	Phillipsburg	New Jersey
United States	CCOP - Western Regional, Arizona	Phoenix	Arizona
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Hillman Cancer Center at University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	Berkshire Physicians and Surgeons, P.C.	Pittsfield	Massachusetts
United States	Cancer Research Network Inc.	Plantation	Florida
United States	Jordan Hospital Club Cancer Center	Plymouth	Massachusetts
United States	Atlantic City Medical Center	Pomona	New Jersey
United States	Wilshire Oncology Medical Group, Incorporated - Pomona	Pomona	California
United States	Blue Water Oncology PC, Port Huron	Port Huron	Michigan
United States	Cancer Institute at Oregon Health and Science University	Portland	Oregon
United States	CCOP - Columbia River Oncology Program	Portland	Oregon
United States	Kaiser Permanente Center for Health Research	Portland	Oregon
United States	Pottstown Memorial Regional Cancer Center	Pottstown	Pennsylvania
United States	St. Francis Hospital and Health Centers	Poughkeepsie	New York
United States	Vassar Brothers Medical Center	Poughkeepsie	New York
United States	Rhode Island Hospital	Providence	Rhode Island
United States	St. Mary-Corwin Regional Medical Center	Pueblo	Colorado
United States	Raleigh Hematology/Oncology Associates, P.A. - Rex Cancer Center	Raleigh	North Carolina
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	Reading Hospital and Medical Center	Reading	Pennsylvania
United States	Booker Cancer Center at Riverview Medical Center	Red Bank	New Jersey
United States	North Valley Breast Clinic	Redding	California
United States	Baylor/Richardson Cancer Center	Richardson	Texas
United States	Henrico Doctors' Hospital - Parham Campus	Richmond	Virginia
United States	MBCCOP - Massey Cancer Center	Richmond	Virginia
United States	Valley Hospital	Ridgewood	New Jersey
United States	Kaiser Permanente Medical Center - Riverside	Riverside	California
United States	Oncology and Hematology Associates of Southwest Virginia, Inc.	Roanoke	Virginia
United States	Genesee Surgical Associates	Rochester	New York
United States	Gynecologic Oncology Associates	Rochester	New York
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Trinity Medical Center - West	Rock Island	Illinois
United States	Rockford Clinic	Rockford	Illinois
United States	Saint Anthony Medical Center	Rockford	Illinois
United States	Swedish-American Regional Cancer Center	Rockford	Illinois
United States	Phelps County Regional Medical Center	Rolla	Missouri
United States	Sutter Roseville Medical Center	Roseville	California
United States	CCOP - Beaumont	Royal Oak	Michigan
United States	Community Cancer Center at Rutland Regional Medical Center	Rutland	Vermont
United States	Sutter Breast Cancer Group	Sacramento	California
United States	Saint Mary's Seton Cancer Institute	Saginaw	Michigan
United States	CCOP - St. Louis-Cape Girardeau	Saint Louis	Missouri
United States	Midwest Hematology Oncology Group, Inc.	Saint Louis	Missouri
United States	Missouri Baptist Cancer Center	Saint Louis	Missouri
United States	Siteman Cancer Center	Saint Louis	Missouri
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego	San Diego	California
United States	Naval Medical Center - San Diego	San Diego	California
United States	California Pacific Medical Center - California Campus	San Francisco	California
United States	UCSF Comprehensive Cancer Center	San Francisco	California
United States	Firelands Regional Medical Center	Sandusky	Ohio
United States	Goodall Hospital	Sanford	Maine
United States	Cancer Center of Santa Barbara	Santa Barbara	California
United States	New Mexico Cancer Care Associates	Santa Fe	New Mexico
United States	CCOP - Santa Rosa Memorial Hospital	Santa Rosa	California
United States	Cancer Care and Research Pavilion at St. Joseph's/Candler	Savannah	Georgia
United States	Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center	Savannah	Georgia
United States	Maine Center for Cancer Medicine and Blood Disorders - Scarborough	Scarborough	Maine
United States	CCOP - Mayo Clinic Scottsdale Oncology Program	Scottsdale	Arizona
United States	Nanticoke Memorial Hospital	Seaford	Delaware
United States	CCOP - Virginia Mason Research Center	Seattle	Washington
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington
United States	Grand View Hospital	Sellersville	Pennsylvania
United States	Cancer Treatment Center at Christus Schumpert St. Mary Place	Shreveport	Louisiana
United States	Siouxland Hematology-Oncology	Sioux City	Iowa
United States	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota
United States	Edward H. Kaplan MD and Associates	Skokie	Illinois
United States	Somerset Medical Center	Somerville	New Jersey
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	Providence Cancer Institute at Providence Hospital	Southfield	Michigan
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Cancer Care Northwest - Spokane North	Spokane	Washington
United States	Rockwood Clinic P.S.	Spokane	Washington
United States	Baystate Regional Cancer Program at Baystate Medical Center	Springfield	Massachusetts
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	Memorial Medical Center	Springfield	Illinois
United States	St. John's Hospital	Springfield	Illinois
United States	St. John's Regional Health Center	Springfield	Missouri
United States	Missouri Cancer Care, P.C. - St. Charles	St. Charles	Missouri
United States	Hematology Oncology, P.C.	Stamford	Connecticut
United States	Stanford Cancer Center at Stanford University Medical Center	Stanford	California
United States	Cancer Center at Iredell Memorial Hospital	Statesville	North Carolina
United States	University Hospital - Stony Brook	Stony Brook	New York
United States	Clinical Research Center of South Florida	Stuart	Florida
United States	Flower Hospital - ProMedica Health System	Sylvania	Ohio
United States	CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.	Syracuse	New York
United States	University Hospital at State University of New York - Upstate Medical University	Syracuse	New York
United States	CCOP - Northwest	Tacoma	Washington
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	CCOP - Scott and White Hospital	Temple	Texas
United States	CCOP - Toledo Community Hospital	Toledo	Ohio
United States	Medical College of Ohio Cancer Institute	Toledo	Ohio
United States	St. Charles Hospital	Toledo	Ohio
United States	St. Vincent Mercy Medical Center	Toledo	Ohio
United States	Toledo Clinic, Incorporated	Toledo	Ohio
United States	Toledo Hospital	Toledo	Ohio
United States	Community Medical Center	Toms River	New Jersey
United States	Torrance Memorial Medical Center	Torrance	California
United States	Northwestern Connecticut Oncology-Hematology Associates	Torrington	Connecticut
United States	Munson Medical Center	Traverse City	Michigan
United States	Capital Health System at Mercer	Trenton	New Jersey
United States	Arizona Cancer Center at University of Arizona Health Sciences Center	Tucson	Arizona
United States	CCOP - Oklahoma	Tulsa	Oklahoma
United States	St. John Health System	Tulsa	Oklahoma
United States	North Mississippi Hematology and Oncology Associates, Limited	Tupelo	Mississippi
United States	University of Texas Health Center at Tyler	Tyler	Texas
United States	Crozer-Chester Medical Center	Upland	Pennsylvania
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	Santa Clarita Valley Cancer Center - UCLA	Valencia	California
United States	Kaiser Permanente Medical Center - Vallejo	Vallejo	California
United States	St. John Macomb Hospital	Warren	Michigan
United States	Cleveland Clinic Health System STAR BCPT	Warrensville Heights	Ohio
United States	Lombardi Cancer Center at Georgetown University Medical Center	Washington	District of Columbia
United States	Providence Hospital	Washington	District of Columbia
United States	Washington Hospital Center	Washington	District of Columbia
United States	Cedar Valley Medical Specialists, P.C.	Waterloo	Iowa
United States	Waukesha Memorial Hospital Regional Cancer Center	Waukesha	Wisconsin
United States	UW Cancer Center Wausau Hospital	Wausau	Wisconsin
United States	Fulton County Health Center	Wauseon	Ohio
United States	Chester County Hospital	West Chester	Pennsylvania
United States	Palm Beach Cancer Institute	West Palm Beach	Florida
United States	Ozarks Medical Center	West Plains	Missouri
United States	CCOP - Wichita	Wichita	Kansas
United States	Windham Community Memorial Hospital	Williamantic	Connecticut
United States	Rice Memorial Hospital	Willmar	Minnesota
United States	CCOP - Christiana Care Health Services	Wilmington	Delaware
United States	New Hanover Regional Medical Center	Wilmington	North Carolina
United States	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina
United States	Forsyth Medical Center	Winston-Salem	North Carolina
United States	Underwood Memorial Hospital	Woodbury	New Jersey
United States	Kaiser Permanente Medical Cener - Woodland Hills	Woodland Hills	California
United States	University of Massachusetts Memorial Medical Center - University Campus	Worcester	Massachusetts
United States	Lankenau Cancer Center at Lankenau Hospital	Wynnewood	Pennsylvania
United States	Yakima Regional Cancer Care Center	Yakima	Washington
United States	Wellspan Health - York Cancer Center	York	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
NSABP Foundation Inc	AstraZeneca, Eli Lilly and Company, National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

References & Publications (10)

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.

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.

Gradishar WJ, Cella D. Selective estrogen receptor modulators and prevention of invasive breast cancer. JAMA. 2006 Jun 21;295(23):2784-6. Epub 2006 Jun 5. — View Citation

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. Review. — View Citation

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 — View Citation

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 — View Citation

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)

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. Review. Erratum in: Expert Rev Anticancer Ther. 2009 Mar;9(3):388. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of invasive breast cancer; superiority of one of the therapies.	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.	Time from randomization to the occurance of invasive breast cancer.	No
Secondary	Effect of the study therapies on the incidence of intraductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS).		Time from randomization to the occurance of DCIS or LCIS.	No
Secondary	Effect of the study therapies on the incidence of endometrial cancer.		Time from randomization to the occurance of endometrial cancer.	No
Secondary	Effect of the study therapies on the incidence of ischemic heart disease.		Time from randomization to the occurance of ischimic heart disease.	No
Secondary	Effect of the study therapies on the incidence of fractures of the hip, spine, or Colles' fractures of the wrist.		Time from randomization to the occurance of fractures of the hip, spine, or Colles' fractures of the wrist.	No
Secondary	Effect of the study therapies on the toxicity and side effects of each therapy.		Incidences of protocol defined toxicities and side effects.	Yes
Secondary	Effect of the study therapies on participants' quality of life.		pre-entry, every 6 months for 5 years, and then annual after 5 years following randomization.	No