A Phase III Trial Evaluating The Role Of Ovarian Function Suppression And The Role Of Exemestane As Adjuvant Therapies For Premenopausal Women With Endocrine Responsive Breast Cancer
OBJECTIVES:
- Compare ovarian function suppression (by triptorelin, oophorectomy, or ovarian
irradiation) in combination with tamoxifen vs tamoxifen alone; exemestane vs tamoxifen
alone; and exemestane vs ovarian function suppression in patients with
endocrine-responsive breast cancer.
- Compare the disease-free and overall survival of patients treated with these regimens.
- Compare the quality of life, including late side effects of early menopause, of
patients treated with these regimens.
- Compare the incidence of second (nonbreast) malignancies in patients treated with these
regimens.
- Compare the sites of first treatment failure in patients treated with these regimens.
- Compare the causes of death without cancer event
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, prior adjuvant/neoadjuvant chemotherapy (yes vs no), and number of
positive axillary and/or internal mammary lymph nodes (0 vs 1 or more) and intended initial
method of ovarian function suppression (triptorelin vs oophorectomy vs ovarian irradiation)
. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive oral tamoxifen daily.
- Arm II: Patients receive tamoxifen as in arm I and ovarian function suppression by 1 of
the following treatments:
- Triptorelin intramuscularly once every 28 days
- Surgical oophorectomy
- Ovarian irradiation once daily for 4 or 5 days
- Arm III: Patients receive oral exemestane daily and ovarian function suppression as in
arm II.
Treatment continues for 5 years in the absence of disease progression or unacceptable
toxicity.
Quality of life is assessed at baseline, every 6 months for 2 years, and then annually for 4
years.
After completion of study therapy, patients are followed periodically.
NOTE: Effective April 30, 2010, enrollment will cease...except for sites outside North
America that are also participating in IBCSG-24-02-SOFT-EST
PROJECTED ACCRUAL: A total of 3,000 patients (1,000 per treatment arm) will be accrued for
this study within 5 years.
NOTE: Effective April 30, 2010, enrollment will cease...except for sites outside North
America that are also participating in IBCSG-24-02-SOFT-EST
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease-free survival
For first time at a median follow up approximately 5 years
No
Prudence Francis, MD
Study Chair
Peter MacCallum Cancer Centre, Australia
United States: Federal Government
CDR0000316456
NCT00066690
August 2003
Name | Location |
---|---|
Suburban Hospital | Bethesda, Maryland 20814 |
Roswell Park Cancer Institute | Buffalo, New York 14263 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
Minnesota Oncology Hematology, PA - Maplewood | Maplewood, Minnesota 55109 |
HealthEast Cancer Care at St. John's Hospital | Maplewood, Minnesota 55109 |
Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota 55407 |
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale, Minnesota 55422-2900 |
St. Francis Cancer Center at St. Francis Medical Center | Shakopee, Minnesota 55379 |
Park Nicollet Cancer Center | St. Louis Park, Minnesota 55416 |
Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Minnesota Oncology Hematology, PA - Woodbury | Woodbury, Minnesota 55125 |
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota 57117-5039 |
Medical X-Ray Center, PC | Sioux Falls, South Dakota 57105 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
Dwight David Eisenhower Army Medical Center | Fort Gordon, Georgia 30905-5650 |
Monmouth Medical Center | Long Branch, New Jersey 07740-6395 |
St. Vincent Mercy Medical Center | Toledo, Ohio 43608 |
Northside Hospital Cancer Center | Atlanta, Georgia 30342-1611 |
CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx, New York 10461 |
Mission Hospitals - Memorial Campus | Asheville, North Carolina 28801 |
Medical University of Ohio Cancer Center | Toledo, Ohio 43614 |
Toledo Hospital | Toledo, Ohio 43606 |
Baylor University Medical Center - Houston | Houston, Texas 77030-2399 |
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital | Huntington, West Virginia 25701 |
St. Vincent's Comprehensive Cancer Center - Manhattan | New York, New York 10011 |
Chester County Hospital | West Chester, Pennsylvania 19380 |
Batte Cancer Center at Northeast Medical Center | Concord, North Carolina 28025 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Don Monti Comprehensive Cancer Center at North Shore University Hospital | Manhasset, New York 11030 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph, Michigan 49085 |
Front Range Cancer Specialists | Fort Collins, Colorado 80528 |
Salinas Valley Memorial Hospital | Salinas, California 93901 |
Kaiser Permanente Medical Office -Vandever Medical Office | San Diego, California 92120 |
John Muir/Mt. Diablo Comprehensive Cancer Center | Walnut Creek, California 94598 |
Poudre Valley Hospital | Fort Collins, Colorado 80524 |
Saint Joseph's Hospital of Atlanta | Atlanta, Georgia 30342-1701 |
Piedmont Hospital | Atlanta, Georgia 30309 |
WellStar Cobb Hospital | Austell, Georgia 30106 |
Charles B. Eberhart Cancer Center at DeKalb Medical Center | Decatur, Georgia 30033 |
Gwinnett Medical Center | Lawrenceville, Georgia 30045 |
Kennestone Cancer Center at Wellstar Kennestone Hospital | Marietta, Georgia 30060 |
Southern Regional Medical Center | Riverdale, Georgia 30274-2600 |
Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Hickman Cancer Center at Bixby Medical Center | Adrian, Michigan 49221 |
Upper Michigan Cancer Center at Marquette General Hospital | Marquette, Michigan 49855 |
Community Cancer Center of Monroe | Monroe, Michigan 48162 |
Kingsbury Center for Cancer Care at Cheshire Medical Center | Keene, New Hampshire 03431 |
Wood County Oncology Center | Bowling Green, Ohio 43402 |
Lima Memorial Hospital | Lima, Ohio 45804 |
Northwest Ohio Oncology Center | Maumee, Ohio 43537 |
Toledo Clinic - Oregon | Oregon, Ohio 43616 |
St. Charles Mercy Hospital | Oregon, Ohio 43616 |
North Coast Cancer Care, Incorporated | Sandusky, Ohio 44870 |
Toledo Clinic, Incorporated - Main Clinic | Toledo, Ohio 43623 |
Fulton County Health Center | Wauseon, Ohio 43567 |
St. Mary Regional Cancer Center | Langhorne, Pennsylvania 19047 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
Missouri Baptist Cancer Center | St. Louis, Missouri 63131 |
Eastern Connecticut Hematology and Oncology Associates | Norwich, Connecticut 06360 |
Carl and Dorothy Bennett Cancer Center at Stamford Hospital | Stamford, Connecticut 06904 |
Harbin Clinic Cancer Center - Medical Oncology | Rome, Georgia 30165 |
McFarland Clinic, PC | Ames, Iowa 50010 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
Haematology-Oncology Associates of Ohio and Michigan, PC | Lambertville, Michigan 48144 |
Mercy Memorial Hospital - Monroe | Monroe, Michigan 48162 |
Flower Hospital Cancer Center | Sylvania, Ohio 43560 |
St. Anne Mercy Hospital | Toledo, Ohio 43623 |
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
Hematology and Oncology Associates of Northeastern Pennsylvania | Scranton, Pennsylvania 18510 |
Fredericksburg Oncology, Incorporated | Fredericksburg, Virginia 22401 |
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center | Green Bay, Wisconsin 54311 |
Vince Lombardi Cancer Clinic - Marinette | Marinette, Wisconsin 54143 |
Community Hospital | Munster, Indiana 46321 |
Aurora Sinai Medical Center | Milwaukee, Wisconsin 53201-0342 |
Lowell General Hospital | Lowell, Massachusetts 01854 |
Rutherford Hospital | Rutherfordton, North Carolina 28139 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Dana-Farber/Brigham and Women's Cancer Center | Boston, Massachusetts 02115 |
Glendale Memorial Hospital Comprehensive Cancer Center | Glendale, California 91204 |
MBCCOP - Meharry Medical College - Nashville | Nashville, Tennessee 37208-3599 |
Providence Cancer Center | Anchorage, Alaska 99508 |
Cancer Center at Phoenixville Hospital | Phoenixville, Pennsylvania 19460 |
Center for Cancer Care at OSF Saint Anthony Medical Center | Rockford, Illinois 61108 |
Mercy General Hospital | Sacramento, California 95819 |
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care | Concord, New Hampshire 03301 |
Center for Cancer Care at Exeter Hospital | Exeter, New Hampshire 03833 |
New Hampshire Oncology - Hematology, PA - Hooksett | Hooksett, New Hampshire 03106 |
AnMed Cancer Center | Anderson, South Carolina 29621 |
NSMC Cancer Center - Peabody | Peabody, Massachusetts 01960 |
Nashville Oncology Associates, PC | Nashville, Tennessee 37203 |
Cancer Care Center at John Muir Health - Concord Campus | Concord, California 94524-4110 |
Renown Institute for Cancer at Renown Regional Medical Center | Reno, Nevada 89502 |
Aurora Women's Pavilion of West Allis Memorial Hospital | West Allis, Wisconsin 53227 |
Bendheim Cancer Center at Greenwich Hospital | Greenwich, Connecticut 06830 |
Norwalk Hospital | Norwalk, Connecticut 06856 |
Community Regional Cancer Care at Community Hospital North | Indianapolis, Indiana 46256 |
Community Regional Cancer Care at Community Hospital East | Indianapolis, Indiana 46219 |
Erlanger Cancer Center at Erlanger Hospital - Baroness | Chattanooga, Tennessee 37403 |
Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh, Wisconsin 54904 |