Spots Global Cancer Trial Database for Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
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Trial Identification
Brief Title: Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
Official Title: A Phase III Trial Evaluating The Role Of Exemestane Plus GnRH Analogue As Adjuvant Therapy For Premenopausal Women With Endocrine Responsive Breast Cancer
Study ID: NCT00066703
Conditions
Study Description
Brief Summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of estrogen. It is not yet known whether giving triptorelin together with exemestane is more effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer. PURPOSE: This randomized phase III trial is studying triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women with hormone-responsive breast cancer.
Detailed Description: OBJECTIVES: * Compare the disease-free survival, breast cancer-free interval, distant recurrence-free interval and overall survival of premenopausal women with endocrine-responsive breast cancer when treated with triptorelin and exemestane vs triptorelin and tamoxifen. * Compare the quality of life, including late side effects of early menopause, of patients treated with these regimens. OUTLINE: This is a randomized, international, multicenter study. Patients are stratified according to planned use of concurrent adjuvant chemotherapy (yes vs no), and number of positive lymph nodes (0 vs 1 or more). Treatment duration is 5 years. Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter. Quality of life is assessed at baseline, every 6 months for 2 years, and annually for 3 years.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center, Burbank, California, United States
Rebecca and John Moores UCSD Cancer Center, La Jolla, California, United States
Providence Holy Cross Cancer Center, Mission Hills, California, United States
Desert Regional Medical Center Comprehensive Cancer Center, Palm Springs, California, United States
Sutter Cancer Center at Roseville Medical Center, Roseville, California, United States
Sutter Cancer Center, Sacramento, California, United States
Mercy General Hospital, Sacramento, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital, Whittier, California, United States
University of Colorado Cancer Center at UC Health Sciences Center, Aurora, Colorado, United States
Shaw Regional Cancer Center, Edwards, Colorado, United States
Poudre Valley Hospital, Fort Collins, Colorado, United States
Front Range Cancer Specialists, Fort Collins, Colorado, United States
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center, Farmington, Connecticut, United States
Sibley Memorial Hospital, Washington, District of Columbia, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida, United States
Northeast Georgia Medical Center, Gainesville, Georgia, United States
Mountain States Tumor Institute at St. Luke's Regional Medical Center, Boise, Idaho, United States
Kootenai Cancer Center - Coeur d'Alene, Coeur d'Alene, Idaho, United States
Resurrection Medical Center, Chicago, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute, Decatur, Illinois, United States
Evanston Hospital, Evanston, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
Elkhart Clinic, LLC, Elkhart, Indiana, United States
Elkhart General Hospital, Elkhart, Indiana, United States
Fort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana, United States
Howard Community Hospital, Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana, United States
Saint Joseph Regional Medical Center, Mishawaka, Indiana, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
Michiana Hematology-Oncology, PC - South Bend, South Bend, Indiana, United States
South Bend Clinic, South Bend, Indiana, United States
Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa, United States
Cancer Center of Kansas, PA - Chanute, Chanute, Kansas, United States
Cancer Center of Kansas, PA - Dodge City, Dodge City, Kansas, United States
Cancer Center of Kansas, PA - El Dorado, El Dorado, Kansas, United States
Cancer Center of Kansas-Independence, Independence, Kansas, United States
Cancer Center of Kansas, PA - Kingman, Kingman, Kansas, United States
Lawrence Memorial Hospital, Lawrence, Kansas, United States
Cancer Center of Kansas, PA - Newton, Newton, Kansas, United States
Menorah Medical Center, Overland Park, Kansas, United States
Cancer Center of Kansas, PA - Parsons, Parsons, Kansas, United States
Cancer Center of Kansas, PA - Pratt, Pratt, Kansas, United States
Cancer Center of Kansas, PA - Salina, Salina, Kansas, United States
Shawnee Mission Medical Center, Shawnee Mission, Kansas, United States
Cotton-O'Neil Cancer Center, Topeka, Kansas, United States
Cancer Center of Kansas, PA - Wellington, Wellington, Kansas, United States
Associates in Womens Health, PA - North Review, Wichita, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower, Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita, Wichita, Kansas, United States
CCOP - Wichita, Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield, Winfield, Kansas, United States
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, United States
Mercy Medical Center, Baltimore, Maryland, United States
Suburban Hospital, Bethesda, Maryland, United States
Frederick Memorial Hospital Regional Cancer Therapy Center, Frederick, Maryland, United States
Tufts Medical Center Cancer Center, Boston, Massachusetts, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Bethke Cancer Center at Emerson Hospital, Concord, Massachusetts, United States
Addison Gilbert Hospital, Gloucester, Massachusetts, United States
Lowell General Hospital, Lowell, Massachusetts, United States
NSMC Cancer Center - Peabody, Peabody, Massachusetts, United States
MidMichigan Medical Center - Midland, Midland, Michigan, United States
William Beaumont Hospital - Royal Oak Campus, Royal Oak, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph, Saint Joseph, Michigan, United States
Lakeside Cancer Specialists, PLLC, Saint Joseph, Michigan, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids, Minnesota, United States
Fairview Southdale Hospital, Edina, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital, Fridley, Minnesota, United States
HealthEast Cancer Care at St. John's Hospital, Maplewood, Minnesota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital, Minneapolis, Minnesota, United States
Hennepin County Medical Center - Minneapolis, Minneapolis, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center, Robbinsdale, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
Park Nicollet Cancer Center, Saint Louis Park, Minnesota, United States
Regions Hospital Cancer Care Center, Saint Paul, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
Ridgeview Medical Center, Waconia, Minnesota, United States
Truman Medical Center - Hospital Hill, Kansas City, Missouri, United States
Saint Luke's Cancer Institute at Saint Luke's Hospital, Kansas City, Missouri, United States
St. Joseph Medical Center, Kansas City, Missouri, United States
North Kansas City Hospital, Kansas City, Missouri, United States
CCOP - Kansas City, Kansas City, Missouri, United States
Research Medical Center, Kansas City, Missouri, United States
Heartland Regional Medical Center, Saint Joseph, Missouri, United States
Saint Louis University Cancer Center, Saint Louis, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, Saint Louis, Missouri, United States
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center, Grand Island, Nebraska, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton, Marlton, New Jersey, United States
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare, Vineland, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua West Jersey, Voorhees, New Jersey, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center, Bronx, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
NYU Cancer Institute at New York University Medical Center, New York, New York, United States
Randolph Hospital, Asheboro, North Carolina, United States
Mission Hospitals - Memorial Campus, Asheville, North Carolina, United States
Hope A Women's Cancer Center, Asheville, North Carolina, United States
Moses Cone Regional Cancer Center at Wesley Long Community Hospital, Greensboro, North Carolina, United States
Pardee Memorial Hospital, Hendersonville, North Carolina, United States
Kinston Medical Specialists, Kinston, North Carolina, United States
Annie Penn Cancer Center, Reidsville, North Carolina, United States
Aultman Cancer Center at Aultman Hospital, Canton, Ohio, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center, Cleveland, Ohio, United States
Geisinger Cancer Institute at Geisinger Health, Danville, Pennsylvania, United States
Geisinger Hazleton Cancer Center, Hazleton, Pennsylvania, United States
Geisinger Medical Group - Scenery Park, State College, Pennsylvania, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center, Wilkes-Barre, Pennsylvania, United States
CCOP - Greenville, Greenville, South Carolina, United States
Medical X-Ray Center, PC, Sioux Falls, South Dakota, United States
Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls, South Dakota, United States
Erlanger Cancer Center at Erlanger Hospital - Baroness, Chattanooga, Tennessee, United States
West Tennessee Cancer Center at Jackson-Madison County General Hospital, Jackson, Tennessee, United States
Doctor's Hospital of Laredo, Laredo, Texas, United States
Mountainview Medical, Berlin, Vermont, United States
Fletcher Allen Health Care - University Health Center Campus, Burlington, Vermont, United States
Madigan Army Medical Center - Tacoma, Tacoma, Washington, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals, Morgantown, West Virginia, United States
Langlade Memorial Hospital, Antigo, Wisconsin, United States
Aurora Memorial Hospital of Burlington, Burlington, Wisconsin, United States
Oncology Alliance - Franklin, Franklin, Wisconsin, United States
Oncology Alliance, SC - Milwaukee - East, Glendale, Wisconsin, United States
Oncology Alliance - Kenosha South, Kenosha, Wisconsin, United States
Aurora Advanced Healthcare East Mequon Clinic, Mequon, Wisconsin, United States
Columbia-Saint Mary's Hospital-Ozaukee, Mequon, Wisconsin, United States
Columbia Saint Mary's Water Tower Medical Commons Milwaukee, Mequon, Wisconsin, United States
Oncology Alliance, SC - Milwaukee - South, Milwaukee, Wisconsin, United States
Aurora Health Center - Racine, Racine, Wisconsin, United States
Aurora Health Center - Waukesha, Waukesha, Wisconsin, United States
University of Wisconcin Cancer Center at Aspirus Wausau Hospital, Wausau, Wisconsin, United States
Oncology Alliance, SC - Milwaukee - West, Wauwatosa, Wisconsin, United States
Cancer Therapy Centre at Campbelltown Hospital, Campbelltown, New South Wales, Australia
Coffs Harbour Health Campus, Coffs Harbour, New South Wales, Australia
Lismore Base Hospital, Lismore, New South Wales, Australia
Cancer Therapy Centre at Liverpool Hospital, Liverpool, New South Wales, Australia
Tamworth Base Hospital, Tamworth, New South Wales, Australia
Manning Base Hospital, Taree, New South Wales, Australia
Tweed Heads Hospital, Tweed Heads, New South Wales, Australia
Newcastle Mater Misericordiae Hospital, Waratah, New South Wales, Australia
Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia
Flinders Medical Centre, Bedford Park, South Australia, Australia
Royal Hobart Hospital, Hobart, Tasmania, Australia
Launceston General Hospital, Launceston, Tasmania, Australia
Box Hill Hospital, Box Hill, Victoria, Australia
Breast Unit Mercy Private, East Melbourne, Victoria, Australia
Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia
St. Vincent's Hospital - Melbourne, Fitzroy, Victoria, Australia
Austin Hospital, Heidelberg, Victoria, Australia
Alfred Hospital, Melbourne, Victoria, Australia
Maroondah Hospital, Ringwood East, Victoria, Australia
Royal Perth Hospital, Perth, Western Australia, Australia
Institut Jules Bordet, Brussels, , Belgium
Centre Hospitalier Hutois, Huy, , Belgium
U.Z. Gasthuisberg, Leuven, , Belgium
CHU Liege - Domaine Universitaire du Sart Tilman, Liege, , Belgium
Centre Hospitalier Peltzer-La Tourelle, Verviers, , Belgium
Hospital de Clinicas de Porto Alegre, Porto Alegre, Rio Grande Do Sul, Brazil
Tom Baker Cancer Centre - Calgary, Calgary, Alberta, Canada
Cross Cancer Institute at University of Alberta, Edmonton, Alberta, Canada
Doctor Leon Richard Oncology Centre, Moncton, New Brunswick, Canada
Margaret and Charles Juravinski Cancer Centre, Hamilton, Ontario, Canada
Trillium Health Centre - Mississauga Site, Toronto, Ontario, Canada
Windsor Regional Cancer Centre at Windsor Regional Hospital, Windsor, Ontario, Canada
Hopital Charles Lemoyne, Greenfield Park, Quebec, Canada
Allan Blair Cancer Centre at Pasqua Hospital, Regina, Saskatchewan, Canada
Saskatoon Cancer Centre at the University of Saskatchewan, Saskatoon, Saskatchewan, Canada
Cairo Oncology Center, Cairo, , Egypt
National Cancer Institute of Egypt, Cairo, , Egypt
Brustzentrum Klinikum Mittelbaden, Baden-Baden, , Germany
Klinikum Deggendorf, Deggendorf, , Germany
Frauenklinik des Universitaetsklinikum Erlangen, Erlangen, , Germany
Universitaetsfrauenklinik Frankfurt, Frankfurt, , Germany
Universitaets-Frauenklinik Goettingen, Göttingen, , Germany
St. Vincentius - Kliniken, Karlsruhe, , Germany
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck, Luebeck, , Germany
Universitatsklinik Mainz, Mainz, , Germany
Universitaetsfrauenklinik Mannheim, Mannheim, , Germany
Klinikum Schwaebisch Gmuend Stauferklinik, Mutlangen, , Germany
Klinikum Nuernberg - Klinikum Nord, Nuremberg, , Germany
Caritas - Krankenhaus Saint Josef, Regensburg, , Germany
Klinikum Obergoeltzsch Rodewisch, Rodewisch, , Germany
Klinikum Rosenheim, Rosenheim, , Germany
Klinikum Landkreis Tuttlingen, Tuttlingen, , Germany
National Institute of Oncology, Budapest, , Hungary
Tata Memorial Hospital, Mumbai, , India
Centro di Riferimento Oncologico - Aviano, Aviano, , Italy
Ospedali Riuniti di Bergamo, Bergamo, , Italy
Azienda Sanitaria di Bolzano, Bolzano, , Italy
Spedali Civili di Brescia, Brescia, , Italy
Ospedale Civile Ramazzini, Carpi, , Italy
European Institute of Oncology, Milan, , Italy
Fondazione Salvatore Maugeri, Pavia, , Italy
Misericordia e Dolce Hospital, Prato, , Italy
Ospedale Civile Rimini, Rimini, , Italy
Istituto Clinico Humanitas, Rozzano, , Italy
Policlinico Universitario Udine, Udine, , Italy
Ospedale di Circolo e Fondazione Macchi, Varese, , Italy
Waikato Hospital, Hamilton, , New Zealand
Instituto Nacional de Enfermedades Neoplasicas, Lima, , Peru
Institute of Oncology - Ljubljana, Ljubljana, , Slovenia
Sandton Oncology Centre, Johannesburg, , South Africa
Sahlgrenska University Hospital, Gothenburg, , Sweden
University Hospital of Linkoping, Linkoping, , Sweden
Skaraborgs Hospital, Skovde, , Sweden
Universitaetsspital-Basel, Basel, , Switzerland
Oncology Institute of Southern Switzerland, Bellinzona, , Switzerland
Inselspital Bern, Bern, , Switzerland
Oncocare Sonnenhof-Klinik Engeriedspital, Bern, , Switzerland
Kantonsspital Graubuenden, Chur, , Switzerland
Onkologie-Praxis ZeTup Chur, Chur, , Switzerland
Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland
Ospedale "la Carita", Locarno, Locarno, , Switzerland
Ospedale Civico, Lugano, , Switzerland
Ospedale Beata Vergine, Mendrisio, , Switzerland
Kantonsspital - St. Gallen, St. Gallen, , Switzerland
Regionalspital, Thun, , Switzerland
UniversitaetsSpital Zuerich, Zurich, , Switzerland
Addenbrooke's Hospital, Cambridge, England, United Kingdom
Peterborough Hospitals Trust, Peterborough, England, United Kingdom
South Tyneside District Hospital, South Shields, England, United Kingdom
Contact Details
Name: Olivia Pagani, MD
Affiliation: Oncology Institute of Southern Switzerland
Role: STUDY_CHAIR
Name: Barbara Walley, MD, FRCPC
Affiliation: Tom Baker Cancer Centre
Role: STUDY_CHAIR
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