A Randomized Comparison Of Medroxyprogesterone Acetate (MA) And Observation For Prevention Of Endometrial Pathology In Postmenopausal Breast Cancer Patients Treated With Tamoxifen, Phase III
OBJECTIVES:
- Compare endometrial pathologic diagnoses (proliferative changes, simple or cystic
hyperplasia, complex adenomatous hyperplasia, hyperplasia with atypia, and carcinoma)
in postmenopausal women with breast carcinoma treated with adjuvant tamoxifen who are
randomly assigned to medroxyprogesterone acetate (MA) vs observation.
- Compare endometrial pathologic diagnoses (persistent endometrial hyperplasia, atypia,
or carcinoma) resulting in tamoxifen discontinuation and intermittent bleeding in
patients treated with these regimens.
- Characterize the incidence of spontaneous regression and progression of simple or
cystic hyperplasia in these patients.
- Characterize endometrial biopsy results using different endometrial stripe width
cut-off points, for cases in which the width is at least 5 mm by endovaginal ultrasound
in patients receiving tamoxifen.
- Compare changes over time in endometrial oncogene expression (e.g., c-fos, c-jun, p53,
IGF1) and receptor status in patients receiving tamoxifen with or without prior
chemotherapy who are randomly assigned to MA vs observation.
- Describe the associations among change in gene expression, receptor status, endometrial
abnormality, length of tamoxifen exposure, and prior chemotherapy in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
adjuvant chemotherapy (yes vs no), number of positive nodes (0-3 vs at least 4), and
endovaginal sonogram endometrial stripe (less than 5 mm vs at least 5 mm). Patients are
randomized to 1 of 2 arms.
All patients receive adjuvant oral tamoxifen daily for five years.
- Arm I: Patients undergo observation.
- Arm II: Patients receive oral medroxyprogesterone acetate on days 1-14. Treatment
repeats every 3 months for 5 years.
Patients are followed every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 330 patients (165 per arm) will be accrued for this study.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Endometrial pathologic diagnosis
Endometrial pathologic diagnosis at 2 years after registration
2 years after registration
No
Ronald K. Potkul, MD
Study Chair
Loyola University
United States: Food and Drug Administration
CDR0000065314
NCT00002920
March 1997
December 2009
Name | Location |
---|---|
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
MBCCOP - Hawaii | Honolulu, Hawaii 96813 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
MBCCOP - Massey Cancer Center | Richmond, Virginia 23298-0037 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York, New York 10016 |
Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
Veterans Affairs Outpatient Clinic - Martinez | Martinez, California 94553 |
CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
CCOP - Santa Rosa Memorial Hospital | Santa Rosa, California 95403 |
CCOP - Central Illinois | Springfield, Illinois 62526 |
Veterans Affairs Medical Center - Lexington | Lexington, Kentucky 40511-1093 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Columbus | Columbus, Ohio 43206 |
Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
CCOP - Dayton | Kettering, Ohio 45429 |
CCOP - Greenville | Greenville, South Carolina 29615 |
Harrington Cancer Center | Amarillo, Texas 79106 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
CCOP - Western Regional, Arizona | Phoenix, Arizona 85006-2726 |
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center | Orange, California 92868 |
University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
MBCCOP - University of Illinois at Chicago | Chicago, Illinois 60612 |
UMASS Memorial Cancer Center - University Campus | Worcester, Massachusetts 01605-2982 |
CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
MBCCOP - University of New Mexico HSC | Albuquerque, New Mexico 87131 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
North Shore University Hospital | Manhasset, New York 11030 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
MBCCOP - Gulf Coast | Mobile, Alabama 36688 |
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) | Phoenix, Arizona 85012 |
Veterans Affairs Medical Center - Tucson | Tucson, Arizona 85723 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Veterans Affairs Medical Center - Denver | Denver, Colorado 80220 |
Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago, Illinois 60612 |
Veterans Affairs Medical Center - Wichita | Wichita, Kansas 67218 |
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
Louisiana State University Health Sciences Center - Shreveport | Shreveport, Louisiana 71130-3932 |
Veterans Affairs Medical Center - Shreveport | Shreveport, Louisiana 71130 |
Veterans Affairs Medical Center - Detroit | Detroit, Michigan 48201-1932 |
Veterans Affairs Medical Center - Jackson | Jackson, Mississippi 39216 |
CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
Veterans Affairs Medical Center - Albuquerque | Albuquerque, New Mexico 87108-5138 |
Veterans Affairs Medical Center - Cincinnati | Cincinnati, Ohio 45220-2288 |
Veterans Affairs Medical Center - Portland | Portland, Oregon 97207 |
Veterans Affairs Medical Center - Charleston | Charleston, South Carolina 29401-5799 |
Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio, Texas 78284 |
Veterans Affairs Medical Center - Temple | Temple, Texas 76504 |
Veterans Affairs Medical Center - Salt Lake City | Salt Lake City, Utah 84148 |
CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
Veterans Affairs Medical Center - Seattle | Seattle, Washington 98108 |
CCOP - Northwest | Tacoma, Washington 98405-0986 |
Veterans Affairs Medical Center - New Orleans | New Orleans, Louisiana 70112 |
Puget Sound Oncology Consortium | Seattle, Washington 98109 |
Naval Medical Center - San Diego | San Diego, California 92134-3202 |
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
Veterans Affairs Medical Center - Memphis | Memphis, Tennessee 38104 |
Providence Alaska Medical Center | Anchorage, Alaska 99508 |
Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
University of California Davis Cancer Center | Sacramento, California 95817 |
Broward General Medical Center | Fort Lauderdale, Florida 33316 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
Louis A. Weiss Memorial Hospital | Chicago, Illinois 60640 |
West Suburban Center for Cancer Care | River Forest, Illinois 60305 |
Cooper University Hospital | Camden, New Jersey 08103 |
Veterans Affairs Medical Center - Asheville | Asheville, North Carolina 28805 |
Lenoir Memorial Hospital Cancer Center | Kinston, North Carolina 28503-1678 |
FirstHealth Moore Regional Hospital | Pinehurst, North Carolina 28374 |
Veterans Affairs Medical Center - Amarillo | Amarillo, Texas 79106 |
Virginia Oncology Associates - Norfolk | Norfolk, Virginia 23502 |
CCOP - Beaumont | Royal Oak, Michigan 48073-6769 |
Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Veterans Affairs Medical Center - Tampa (Haley) | Tampa, Florida 33612 |
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536-0084 |
Tulane Cancer Center at Tulane University Hospital and Clinic | New Orleans, Louisiana 70112 |
Cancer Research Center at Boston Medical Center | Boston, Massachusetts 02118 |
St. Louis University Hospital Cancer Center | Saint Louis, Missouri 63110 |
Herbert Irving Comprehensive Cancer Center at Columbia University | New York, New York 10032 |
Cancer Institute at Oregon Health and Science University | Portland, Oregon 97201-3098 |
Oklahoma University Medical Center | Oklahoma City, Oklahoma 73104 |
Mount Sinai Medical Center | New York, New York 10029 |
SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Vermont Cancer Center at University of Vermont | Burlington, Vermont 05405-0075 |
MBCCOP - Howard University Cancer Center | Washington, District of Columbia 20060 |
Veterans Affairs Medical Center - Little Rock | Little Rock, Arkansas 72205 |
Veterans Affairs Medical Center - Loma Linda (Pettis) | Loma Linda, California 92357 |
Lombardi Cancer Center at Georgetown University Medical Center | Washington, District of Columbia 20007 |
Veterans Affairs Medical Center - Hines | Hines, Illinois 60141 |
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
Josephine Ford Cancer Center at Henry Ford Health System | Detroit, Michigan 48202 |
Providence Cancer Institute at Providence Hospital - Southfield | Southfield, Michigan 48075 |
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha, Nebraska 68198-7680 |
New Hampshire Oncology-Hematology, PA - Hooksett | Hooksett, New Hampshire 03106 |
NorthEast Oncology Associates - Concord | Concord, North Carolina 28025 |
Arthur G. James Cancer Hospital at Ohio State University | Columbus, Ohio 43210-1240 |
University of Tennessee Cancer Institute at Methodist Central Hospital | Memphis, Tennessee 38104 |
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke | Roanoke, Virginia 24014 |