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| Sponsor: | Radiation Therapy Oncology Group |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Cancer and Leukemia Group B NCIC Clinical Trials Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003857 |
Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. It is not yet known if radiation therapy is more effective than observation, with or without tamoxifen, in treating ductal carcinoma in situ.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with that of observation, with or without tamoxifen, in treating women who have ductal carcinoma in situ.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: tamoxifen citrate Procedure: adjuvant therapy Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | Phase III Trial of Tamoxifen Alone vs. Tamoxifen Plus RT for Good Risk Duct Carcinoma In-Situ (DCIS) of the Female Breast |
| Estimated Enrollment: | 1790 |
| Study Start Date: | December 1999 |
| Estimated Primary Completion Date: | February 2004 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (under 50 vs 50 and over), final path margins (negative vs 3-9 mm vs at least 10 mm), mammographic size of primary (no greater than 1 cm vs greater than 1 cm to 2.5 cm), nuclei grade (low vs intermediate), and tamoxifen use (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,790 patients will be accrued for this study within 6 years.
Eligibility| Ages Eligible for Study: | 26 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Ductal carcinoma in situ (DCIS) of the breast detected by mammogram at the time of diagnosis
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Mobile Infirmary Medical Center | |
| Mobile, Alabama, United States, 36652-2144 | |
| United States, Alaska | |
| Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital | |
| Fairbanks, Alaska, United States, 99701 | |
| United States, Arizona | |
| Arizona Oncology Services Foundation | |
| Phoenix, Arizona, United States, 85013 | |
| United States, Arkansas | |
| Saint Joseph's Mercy Cancer Center | |
| Hot Springs, Arkansas, United States, 71913 | |
| United States, California | |
| Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital | |
| Inglewood, California, United States, 90301 | |
| Mount Diablo Regional Cancer Center | |
| Concord, California, United States, 94524-4110 | |
| CCOP - Santa Rosa Memorial Hospital | |
| Sana Rosa, California, United States, 95405 | |
| Enloe Cancer Center at Enloe Medical Center | |
| Chico, California, United States, 95926 | |
| John Muir/Mt. Diablo Comprehensive Cancer Center | |
| Walnut Creek, California, United States, 94598 | |
| Memorial Medical Center Cancer Services | |
| Modesto, California, United States, 95355 | |
| CCOP - Bay Area Tumor Institute | |
| Oakland, California, United States, 94609 | |
| North Bay Cancer Center | |
| Fairfield, California, United States, 94533 | |
| Providence Holy Cross Cancer Center | |
| Mission Hills, California, United States, 91346-9600 | |
| Providence Saint Joseph Medical Center - Burbank | |
| Burbank, California, United States, 91505 | |
| Radiological Associates of Sacramento Medical Group, Incorporated | |
| Sacramento, California, United States, 95815 | |
| Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center | |
| Pomona, California, United States, 91767 | |
| Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital | |
| Whittier, California, United States, 90602 | |
| Saint Agnes Medical Center | |
| Fresno, California, United States, 93720-3397 | |
| Torrance Memorial Medical Center | |
| Torrance, California, United States, 90509 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90089-9181 | |
| Washington Township Hospital | |
| Fremont, California, United States, 94538 | |
| United States, Connecticut | |
| Eastern Connecticut Hematology and Oncology Associates | |
| Norwich, Connecticut, United States, 06360 | |
| Hospital of Saint Raphael | |
| New Haven, Connecticut, United States, 06511 | |
| St. Vincent's Medical Center | |
| Bridgeport, Connecticut, United States, 06606 | |
| United States, Delaware | |
| CCOP - Christiana Care Health Services | |
| Newark, Delaware, United States, 19713 | |
| United States, District of Columbia | |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| Baptist-South Miami Regional Cancer Program | |
| Miami, Florida, United States, 33176 | |
| Lakeland Regional Cancer Center at Lakeland Regional Medical Center | |
| Lakeland, Florida, United States, 33805 | |
| Mayo Clinic - Jacksonville | |
| Jacksonville, Florida, United States, 32224 | |
| University of Florida Shands Cancer Center | |
| Gainesville, Florida, United States, 32610-0232 | |
| University of Miami Sylvester Comprehensive Cancer Center | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler | |
| Savannah, Georgia, United States, 31405 | |
| Northeast Georgia Medical Center | |
| Gainesville, Georgia, United States, 30501 | |
| United States, Hawaii | |
| Cancer Research Center of Hawaii | |
| Honolula, Hawaii, United States, 96813 | |
| Leeward Radiation Oncology Center | |
| Ewa Beach, Hawaii, United States, 96706 | |
| Queen's Cancer Institute at Queen's Medical Center | |
| Honolulu, Hawaii, United States, 96813 | |
| St. Francis Medical Center | |
| Honolulu, Hawaii, United States, 96817 | |
| Tripler Army Medical Center | |
| Honolulu, Hawaii, United States, 96859 | |
| United States, Idaho | |
| Hematology Oncology Associates of Eastern Idaho | |
| Idaho Falls, Idaho, United States, 83404 | |
| St. Luke's Mountain States Tumor Institute - Boise | |
| Boise, Idaho, United States, 83712 | |
| United States, Illinois | |
| Carle Cancer Center at Carle Foundation Hospital | |
| Urbana, Illinois, United States, 61801 | |
| BroMenn Regional Medical Center | |
| Normal, Illinois, United States, 61761 | |
| Cancer Treatment Center at Pekin Hospital | |
| Pekin, Illinois, United States, 61554 | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| Advocate Good Samaritan Hospital | |
| Downers Grove, Illinois, United States, 60515 | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| CCOP - Illinois Oncology Research Association | |
| Peoria, Illinois, United States, 61615 | |
| Community Cancer Center | |
| Normal, Illinois, United States, 61761 | |
| Creticos Cancer Center at Advocate Illinois Masonic Medical Center | |
| Chicago, Illinois, United States, 60657 | |
| Good Shepherd Hospital | |
| Barrington, Illinois, United States, 60010 | |
| InterCommunity Cancer Center of Western Illinois | |
| Galesburg, Illinois, United States, 61401 | |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | |
| Peoria, Illinois, United States, 61615 | |
| Joliet Oncology-Hematology Associates, Limited - West | |
| Joliet, Illinois, United States, 60435 | |
| Lutheran General Cancer Care Center | |
| Park Ridge, Illinois, United States, 60068 | |
| Methodist Medical Center of Illinois | |
| Peoria, Illinois, United States, 61636 | |
| Northwest Community Hospital | |
| Arlington Heights, Illinois, United States, 60005 | |
| John H. Stroger, Jr. Hospital of Cook County | |
| Chicago, Illinois, United States, 60612-3785 | |
| OSF St. Francis Medical Center | |
| Peoria, Illinois, United States, 61637 | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
| Chicago, Illinois, United States, 60611-3013 | |
| Rush-Copley Cancer Care Center | |
| Aurora, Illinois, United States, 60507 | |
| St. Joseph Medical Center | |
| Bloomington, Illinois, United States, 61701 | |
| Valley Cancer Center | |
| Spring Valley, Illinois, United States, 61362 | |
| United States, Indiana | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| Memorial Hospital of South Bend | |
| South Bend, Indiana, United States, 46601 | |
| Elkhart General Hospital | |
| Elkhart, Indiana, United States, 46515 | |
| Howard Community Hospital at Howard Regional Health System | |
| Kokomo, Indiana, United States, 46904 | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5289 | |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | |
| La Porte, Indiana, United States, 46350 | |
| Parkview Regional Cancer Center at Parkview Health | |
| Fort Wayne, Indiana, United States, 46805 | |
| Regional Cancer Institute at Bloomington Hospital | |
| Bloomington, Indiana, United States, 47403 | |
| Saint Anthony Memorial Health Centers | |
| Michigan City, Indiana, United States, 46360 | |
| St. John's Cancer Center at St. John's Medical Center | |
| Anderson, Indiana, United States, 46016 | |
| United States, Iowa | |
| Cedar Rapids Oncology Associates | |
| Cedar Rapids, Iowa, United States, 52403 | |
| Mercy Regional Cancer Center at Mercy Medical Center | |
| Cedar Rapids, Iowa, United States, 52403 | |
| St. Luke's Hospital | |
| Cedar Rapids, Iowa, United States, 52402 | |
| United States, Kansas | |
| St. Francis Comprehensive Cancer Center | |
| Topeka, Kansas, United States, 66606 | |
| Stormont-Vail Cancer Center | |
| Topeka, Kansas, United States, 66604 | |
| United States, Kentucky | |
| Cancer Treatment Center for Southern Kentucky | |
| Bowling Green, Kentucky, United States, 42101 | |
| Central Baptist Hospital | |
| Lexington, Kentucky, United States, 40503-9985 | |
| Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County | |
| Madisonville, Kentucky, United States, 42431 | |
| United States, Maine | |
| Central Maine Medical Center | |
| Lewiston, Maine, United States, 04240 | |
| Maine Medical Center - Bramhall Campus | |
| Portland, Maine, United States, 04102 | |
| United States, Maryland | |
| DeCesaris Cancer Institute at Anne Arundel Medical Center | |
| Annapolis, Maryland, United States, 21401 | |
| Greater Baltimore Medical Center | |
| Baltimore, Maryland, United States, 21204 | |
| Peninsula Regional Medical Center | |
| Salisbury, Maryland, United States, 21801 | |
| Suburban Hospital | |
| Bethesda, Maryland, United States, 20814 | |
| United States, Massachusetts | |
| Cape Cod Hospital | |
| Hyannis, Massachusetts, United States, 02601 | |
| Bethke Cancer Center at Emerson Hospital | |
| Concord, Massachusetts, United States, 01742 | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Cancer Research Center at Boston Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| Baystate Regional Cancer Program at D'Amour Center for Cancer Care | |
| Springfield, Massachusetts, United States, 01199 | |
| Caritas Norwood Hospital | |
| Norwood, Massachusetts, United States, 02062 | |
| Community Cancer Care at Milford Regional Medical Center | |
| Milford, Massachusetts, United States, 01757 | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Hudner Oncology Center at Saint Anne's Hospital | |
| Fall River, Massachusetts, United States, 02721 | |
| MetroWest Medical Center - Framingham Union Hospital | |
| Framingham, Massachusetts, United States, 01702 | |
| Lowell General Hospital | |
| Lowell, Massachusetts, United States, 01854 | |
| Massachusetts General Hospital Cancer Center | |
| Boston, Massachusetts, United States, 02114 | |
| Lahey Clinic Medical Center - Burlington | |
| Burlington, Massachusetts, United States, 01805 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| Borgess Medical Center | |
| Kalamazooaa, Michigan, United States, 49001 | |
| Breslin Cancer Center at Ingham Regional Medical Center | |
| Lansing, Michigan, United States, 48910 | |
| Bronson Methodist Hospital | |
| Kalamazoo, Michigan, United States, 49007 | |
| Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | |
| St. Joseph, Michigan, United States, 49085 | |
| CCOP - Michigan Cancer Research Consortium | |
| Ann Arbor, Michigan, United States, 48106 | |
| Foote Hospital | |
| Jackson, Michigan, United States, 49201 | |
| Genesys Hurley Cancer Institute | |
| Flint, Michigan, United States, 48503 | |
| Great Lakes Cancer Institute at McLaren Regional Medical Center | |
| Flint, Michigan, United States, 48532 | |
| Green Bay Oncology, Limited - Escanaba | |
| Escanaba, Michigan, United States, 49431 | |
| Green Bay Oncology, Limited - Iron Mountain | |
| Iron Mountain, Michigan, United States, 49801 | |
| Hickman Cancer Center at Bixby Medical Center | |
| Adrian, Michigan, United States, 49221 | |
| Josephine Ford Cancer Center at Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| Lacks Cancer Center at Saint Mary's Mercy Medical Center | |
| Grand Rapids, Michigan, United States, 49503 | |
| CCOP - Grand Rapids | |
| Grand Rapids, Michigan, United States, 49503 | |
| MidMichigan Medical Center - Midland | |
| Midland, Michigan, United States, 48670 | |
| Munson Medical Center | |
| Traverse City, Michigan, United States, 49684 | |
| Northern Michigan Hospital | |
| Petoskey, Michigan, United States, 49770 | |
| Seton Cancer Institute - Saginaw | |
| Saginaw, Michigan, United States, 48601 | |
| Spectrum Health Cancer Care - Butterworth Campus | |
| Grand Rapids, Michigan, United States, 49503 | |
| St. John Macomb Hospital | |
| Warren, Michigan, United States, 48093 | |
| William Beaumont Hospital - Royal Oak Campus | |
| Royal Oak, Michigan, United States, 48073 | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0942 | |
| Upper Michigan Cancer Center at Marquette General Hospital | |
| Marquette, Michigan, United States, 49855 | |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | |
| Grosse Pointe Woods, Michigan, United States, 48236 | |
| West Michigan Cancer Center | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital | |
| Ann Arbor, Michigan, United States, 48106-0995 | |
| United States, Minnesota | |
| Park Nicollet Health Services | |
| St. Louis Park, Minnesota, United States, 55416 | |
| CentraCare Clinic - River Campus | |
| St. Cloud, Minnesota, United States, 56303 | |
| Coborn Cancer Center | |
| Saint Cloud, Minnesota, United States, 56303 | |
| Fairview Ridges Hospital | |
| Burnsville, Minnesota, United States, 55337 | |
| Fairview Southdale Hospital | |
| Edina, Minnesota, United States, 55435 | |
| Hubert H. Humphrey Cancer Center at North Memorial Medical Center | |
| Robbinsdale, Minnesota, United States, 55422-2900 | |
| Immanuel St. Joseph's Clinic | |
| Mankato, Minnesota, United States, 56002 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| Mercy and Unity Cancer Center at Unity Hospital | |
| Fridley, Minnesota, United States, 55432 | |
| Mercy and Unity Cancer Center at Mercy Hospital | |
| Coon Rapids, Minnesota, United States, 55433 | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| Regions Hospital Cancer Care Center | |
| St. Paul, Minnesota, United States, 55101 | |
| Ridgeview Medical Center | |
| Waconia, Minnesota, United States, 55387 | |
| St. Mary's - Duluth Clinic Cancer Center | |
| Duluth, Minnesota, United States, 55805 | |
| United Hospital | |
| St. Paul, Minnesota, United States, 55102 | |
| Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | |
| Minneapolis, Minnesota, United States, 55407 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216 | |
| United States, Missouri | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| United States, Montana | |
| CCOP - Montana Cancer Consortium | |
| Billings, Montana, United States, 59101 | |
| Deaconess Billings Clinic - Downtown | |
| Billings, Montana, United States, 59107-7000 | |
| Great Falls Clinic | |
| Great Falls, Montana, United States, 59405 | |
| Northern Rockies Radiation Oncology Center | |
| Billings, Montana, United States, 59101 | |
| United States, Nebraska | |
| Good Samaritan Cancer Center at Good Samaritan Hospital | |
| Kearney, Nebraska, United States, 68848-1990 | |
| Methodist Cancer Center at Methodist Hospital - Omaha | |
| Omaha, Nebraska, United States, 68114 | |
| United States, Nevada | |
| CCOP - Nevada Cancer Research Foundation | |
| Las Vegas, Nevada, United States, 89106 | |
| United States, New Hampshire | |
| Dartmouth - Hitchcock Concord | |
| Concord, New Hampshire, United States, 03301 | |
| Elliot Regional Cancer Center at Elliot Hospital | |
| Manchester, New Hampshire, United States, 03103 | |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| Seacoast Cancer Center at Wentworth-Douglass Hospital | |
| Dover, New Hampshire, United States, 03820 | |
| United States, New Jersey | |
| AtlantiCare Regional Medical Center | |
| Pomona, New Jersey, United States, 08240 | |
| Booker Cancer Center at Riverview Medical Center | |
| Red Bank, New Jersey, United States, 07701 | |
| Cancer Institute of New Jersey at Cooper - Voorhees | |
| Voorhees, New Jersey, United States, 08043 | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08903 | |
| Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center | |
| Englewood, New Jersey, United States, 07631 | |
| Fox Chase Cancer Center at St. Francis Medical Center | |
| Trenton, New Jersey, United States, 08629 | |
| Fox Chase Virtua Health Cancer Program - Marlton | |
| Marlton, New Jersey, United States, 08053 | |
| John F. Kennedy Medical Center | |
| Edison, New Jersey, United States, 08818 | |
| Monmouth Medical Center | |
| Long Branch, New Jersey, United States, 07740-6395 | |
| Newark Beth Israel Medical Center | |
| Newark, New Jersey, United States, 07112 | |
| Saint Peter's University Hospital | |
| New Brunswick, New Jersey, United States, 08903 | |
| Veterans Affairs Medical Center - East Orange | |
| East Orange, New Jersey, United States, 07018-1095 | |
| United States, New Mexico | |
| Albuquerque Regional Medical Center at Lovelace Sandia Health System | |
| Albuquerque, New Mexico, United States, 87102 | |
| University of New Mexico Cancer Research and Treatment Center | |
| Albuquerque, New Mexico, United States, 87131-5636 | |
| United States, New York | |
| CCOP - Hematology-Oncology Associates of Central New York | |
| Syracuse, New York, United States, 13057 | |
| CCOP - North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| Long Island College Hospital | |
| Brooklyn, New York, United States, 11201 | |
| Long Island Jewish Medical Center | |
| New Hyde Park, New York, United States, 11042 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| Tucker Center for Cancer Care at Orange Regional Medical Center | |
| Middletown, New York, United States, 10940-4199 | |
| United States, North Carolina | |
| Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital | |
| Greenville, North Carolina, United States, 27835-6028 | |
| Blumenthal Cancer Center at Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Lenoir Memorial Cancer Center | |
| Kinston, North Carolina, United States, 28501 | |
| Batte Cancer Center at Northeast Medical Center | |
| Concord, North Carolina, United States, 28025 | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Moore Regional Community Hospital Comprehensive Cancer Center | |
| Pinehurst, North Carolina, United States, 28374 | |
| Pardee Memorial Hospital | |
| Hendersonville, North Carolina, United States, 28791 | |
| Rex Cancer Center at Rex Hospital | |
| Raleigh, North Carolina, United States, 27607 | |
| Rutherford Hospital | |
| Rutherfordton, North Carolina, United States, 28139 | |
| Wayne Memorial Hospital, Incorporated | |
| Goldsboro, North Carolina, United States, 27534 | |
| Wayne Radiation Oncology | |
| Goldsboro, North Carolina, United States, 27534 | |
| Wilmed Radiation Oncology Services | |
| Wilson, North Carolina, United States, 27893 | |
| Zimmer Cancer Center at New Hanover Regional Medical Center | |
| Wilmington, North Carolina, United States, 28401 | |
| United States, North Dakota | |
| Trinity Cancer Care Center | |
| Minot, North Dakota, United States, 58701 | |
| United States, Ohio | |
| Adena Regional Medical Center | |
| Chillicothe, Ohio, United States, 45601 | |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | |
| Columbus, Ohio, United States, 43210-1240 | |
| Lima Memorial Hospital | |
| Lima, Ohio, United States, 45804 | |
| Blanchard Valley Medical Associates | |
| Findlay, Ohio, United States, 45840 | |
| Cancer Treatment Center at Good Samaritan Hospital | |
| Cincinnati, Ohio, United States, 45220 | |
| Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106 | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43215 | |
| CCOP - Toledo Community Hospital | |
| Toledo, Ohio, United States, 43623 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Firelands Regional Medical Center | |
| Sandusky, Ohio, United States, 44870 | |
| Grady Memorial Hospital | |
| Delaware, Ohio, United States, 43015 | |
| Hillcrest Cancer Center at Hillcrest Hospital | |
| Mayfield Heights, Ohio, United States, 44124 | |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | |
| Newark, Ohio, United States, 43055 | |
| Bethesda North Hospital | |
| Cincinnati, Ohio, United States, 45242 | |
| McDowell Cancer Center at Akron General Medical Center | |
| Akron, Ohio, United States, 44307 | |
| Medical University of Ohio Cancer Center | |
| Toledo, Ohio, United States, 43614 | |
| Mercy Cancer Center at Mercy Medical Center | |
| Canton, Ohio, United States, 44708 | |
| Mercy Medical Center | |
| Springfield, Ohio, United States, 45504 | |
| MetroHealth's Cancer Care Center at MetroHealth Medical Center | |
| Cleveland, Ohio, United States, 44109 | |
| Mount Carmel Health - West Hospital | |
| Columbus, Ohio, United States, 43222 | |
| St. Joseph Cancer Center at St. Joseph Health Center | |
| Warren, Ohio, United States, 44484 | |
| Northwest Ohio Oncology Center | |
| Maumee, Ohio, United States, 43623 | |
| Promedica Cancer Center at Flower Hospital | |
| Sylvania, Ohio, United States, 43560 | |
| Riverside Methodist Hospital Cancer Care | |
| Columbus, Ohio, United States, 43214-3998 | |
| St. Charles Mercy Hospital | |
| Oregon, Ohio, United States, 43616 | |
| Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital | |
| Westerville, Ohio, United States, 43081 | |
| St. Rita's Medical Center | |
| Lima, Ohio, United States, 45801 | |
| St. Vincent Mercy Medical Center | |
| Toledo, Ohio, United States, 43608 | |
| Strecker Cancer Center at Marietta Memorial Hospital | |
| Marietta, Ohio, United States, 45750 | |
| Toledo Clinic, Incorporated - Main Clinic | |
| Toledo, Ohio, United States, 43623 | |
| United States, Oklahoma | |
| Natalie Warren Bryant Cancer Center at St. Francis Hospital | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Oregon | |
| Cancer Institute at Oregon Health and Science University | |
| Portland, Oregon, United States, 97239-3098 | |
| Legacy Meridian Park Hospital | |
| Tualatin, Oregon, United States, 97062 | |
| Dubs Cancer Center at Rogue Valley Medical Center | |
| Medford, Oregon, United States, 97504 | |
| Legacy Emanuel Hospital and Health Center & Children's Hospital | |
| Portland, Oregon, United States, 97227 | |
| Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center | |
| Portland, Oregon, United States, 97210 | |
| CCOP - Columbia River Oncology Program | |
| Portland, Oregon, United States, 97225 | |
| Legacy Mount Hood Medical Center | |
| Gresham, Oregon, United States, 97030 | |
| Providence Cancer Center at Providence Portland Medical Center | |
| Portland, Oregon, United States, 97213-2967 | |
| Providence Medford Medical Center | |
| Medford, Oregon, United States, 97504 | |
| Providence Milwaukie Hospital | |
| Milwaukie, Oregon, United States, 97222 | |
| Providence St. Vincent Medical Center | |
| Portland, Oregon, United States, 97225 | |
| Three Rivers Community Hospital | |
| Grants Pass, Oregon, United States, 97527 | |
| United States, Pennsylvania | |
| Bryn Mawr Hospital | |
| Bryn Mawr, Pennsylvania, United States, 19010 | |
| CCOP - MainLine Health | |
| Wynnewood, Pennsylvania, United States, 19096 | |
| Easton Regional Cancer Center at Easton Hospital | |
| Easton, Pennsylvania, United States, 18042 | |
| Fox Chase-Temple Cancer Center CCOP Research Base | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | |
| Wilkes-Barre, Pennsylvania, United States, 18711 | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822-0001 | |
| St. Luke's Hospital Cancer Center | |
| Bethlehem, Pennsylvania, United States, 18015 | |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19107-5541 | |
| Lankenau Cancer Center at Lankenau Hospital | |
| Wynnewood, Pennsylvania, United States, 19096 | |
| Mercy Cancer Institute at Mercy Hospital | |
| Pittsburgh, Pennsylvania, United States, 15219 | |
| Mercy Fitzgerald Hospital | |
| Darby, Pennsylvania, United States, 19023 | |
| Mercy Hospital Cancer Center - Scranton | |
| Scranton, Pennsylvania, United States, 18501 | |
| Mount Nittany Medical Center | |
| State College, Pennsylvania, United States, 16803 | |
| Paoli Memorial Hospital | |
| Paoli, Pennsylvania, United States, 19301-1792 | |
| Reading Hospital and Medical Center | |
| Reading, Pennsylvania, United States, 19612-6052 | |
| Rosenfeld Cancer Center at Abington Memorial Hospital | |
| Abington, Pennsylvania, United States, 19001 | |
| Hillman Cancer Center at University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| St. Mary Regional Cancer Center | |
| Langhorne, Pennsylvania, United States, 19047 | |
| York Cancer Center at Wellspan Health | |
| York, Pennsylvania, United States, 17403 | |
| United States, South Carolina | |
| AnMed Health Cancer Center | |
| Anderson, South Carolina, United States, 29621 | |
| Bon Secours St. Francis Health System | |
| Greenville, South Carolina, United States, 29601 | |
| CCOP - Greenville | |
| Greenville, South Carolina, United States, 29615 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | |
| Spartanburg, South Carolina, United States, 29303 | |
| Palmetto Health South Carolina Cancer Center | |
| Columbia, South Carolina, United States, 29203 | |
| United States, South Dakota | |
| Medical X-Ray Center, PC | |
| Sioux Falls, South Dakota, United States, 57105 | |
| Rapid City Regional Hospital | |
| Rapid City, South Dakota, United States, 57701 | |
| Sioux Valley Hospital and University of South Dakota Medical Center | |
| Sioux Falls, South Dakota, United States, 57117-5039 | |
| United States, Texas | |
| Doctor's Hospital of Laredo | |
| Laredo, Texas, United States, 78041 | |
| Joe Arrington Cancer Research and Treatment Center | |
| Lubbock, Texas, United States, 79410-1894 | |
| M.D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555-0209 | |
| United States, Utah | |
| Cottonwood Hospital Medical Center | |
| Murray, Utah, United States, 84107 | |
| Dixie Regional Medical Center - East Campus | |
| Saint George, Utah, United States, 84770 | |
| LDS Hospital | |
| Salt Lake City, Utah, United States, 84143 | |
| McKay-Dee Hospital Center | |
| Ogden, Utah, United States, 84403 | |
| Utah Cancer Specialists at UCS Cancer Center | |
| Salt Lake City, Utah, United States, 84106 | |
| Utah Valley Regional Medical Center - Provo | |
| Provo, Utah, United States, 84604 | |
| United States, Vermont | |
| Community Cancer Center at Rutland Regional Medical Center | |
| Rutland, Vermont, United States, 05701 | |
| Fletcher Allen Health Care - University Health Center Campus | |
| Burlington, Vermont, United States, 05401 | |
| United States, Virginia | |
| Martha Jefferson Hospital Cancer Care Center | |
| Charlottesville, Virginia, United States, 22901 | |
| Naval Medical Center - Portsmouth | |
| Portsmouth, Virginia, United States, 23708-2197 | |
| United States, Washington | |
| Cancer Care Northwest - Spokane South | |
| Spokane, Washington, United States, 99202 | |
| Cascade Cancer Center at Evergreen Hospital Medical Center | |
| Kirkland, Washington, United States, 98033 | |
| CCOP - Virginia Mason Research Center | |
| Seattle, Washington, United States, 98101 | |
| Group Health Central Hospital | |
| Seattle, Washington, United States, 98112 | |
| University Cancer Center at University of Washington Medical Center | |
| Seattle, Washington, United States, 98195-6043 | |
| Southwest Washington Medical Center Cancer Center | |
| Vancouver, Washington, United States, 98668 | |
| St. Francis Hospital | |
| Federal Way, Washington, United States, 98003 | |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | |
| Seattle, Washington, United States, 98122-4307 | |
| Madigan Army Medical Center - Tacoma | |
| Tacoma, Washington, United States, 98431 | |
| United States, Wisconsin | |
| Bay Area Cancer Care Center at Bay Area Medical Center | |
| Marinette, Wisconsin, United States, 54143 | |
| Theda Care Cancer Institute | |
| Appleton, Wisconsin, United States, 54911 | |
| Community Memorial Hospital Cancer Care Center | |
| Menomonee Falls, Wisconsin, United States, 53051 | |
| Green Bay Oncology, Limited - Oconto Falls | |
| Oconto Falls, Wisconsin, United States, 54154 | |
| Green Bay Oncology, Limited - Sturgeon Bay | |
| Sturgeon Bay, Wisconsin, United States, 54235 | |
| Green Bay Oncology, Limited at St. Mary's Hospital | |
| Green Bay, Wisconsin, United States, 54303 | |
| Green Bay Oncology, Limited at St. Vincent Hospital | |
| Green Bay, Wisconsin, United States, 54301-3526 | |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | |
| La Crosse, Wisconsin, United States, 54601 | |
| Regional Cancer Center at Oconomowoc Memorial Hospital | |
| Oconomowoc, Wisconsin, United States, 53066 | |
| St. Mary's Hospital Medical Center - Green Bay | |
| Green Bay, Wisconsin, United States, 54303 | |
| St. Vincent Hospital Regional Cancer Center | |
| Green Bay, Wisconsin, United States, 54307-3508 | |
| Columbia St. Mary's Cancer Care Center | |
| Milwaukee, Wisconsin, United States, 53211 | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-6164 | |
| Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center | |
| Green Bay, Wisconsin, United States, 54311 | |
| Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center | |
| Milwaukee, Wisconsin, United States, 53215 | |
| Waukesha Memorial Hospital Regional Cancer Center | |
| Waukesha, Wisconsin, United States, 53188 | |
| West Allis Memorial Hospital | |
| West Milwaukee, Wisconsin, United States, 53227 | |
| Canada | |
| Centre Hospitalier Regional de Rimouski | |
| Quebec, Canada, G1S 4L8 | |
| Canada, Alberta | |
| Cross Cancer Institute at University of Alberta | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Lethbridge Cancer Centre | |
| Lethbridge, Alberta, Canada, T1J 1W5 | |
| Canada, British Columbia | |
| BCCA - Fraser Valley Cancer Centre | |
| Surrey, British Columbia, Canada, V3V 1Z2 | |
| British Columbia Cancer Agency - Centre for the Southern Interior | |
| Kelowna, British Columbia, Canada, V1Y 5L3 | |
| British Columbia Cancer Agency - Vancouver Cancer Centre | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| British Columbia Cancer Agency - Vancouver Island Cancer Centre | |
| Victoria, British Columbia, Canada, V8R 6V5 | |
| G. Steinhoff Clinical Research | |
| Victoria, British Columbia, Canada, V8V 3N1 | |
| Lions Gate Hospital | |
| North Vancouver, British Columbia, Canada, V7L 2P9 | |
| Nanaimo Cancer Clinic at Nanaimo Regional General Hospital | |
| Nanaimo, British Columbia, Canada, V9S 2B7 | |
| Prostate Centre at Vancouver General Hospital | |
| Vancouver, British Columbia, Canada, V5Z 3J5 | |
| Providence Health Care - Vancouver | |
| Vancouver, British Columbia, Canada, V6Z 1Y6 | |
| Canada, Manitoba | |
| CancerCare Manitoba | |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Canada, New Brunswick | |
| Moncton Hospital | |
| Moncton, New Brunswick, Canada, E1C 6ZB | |
| Saint John Regional Hospital | |
| Saint John, New Brunswick, Canada, E2L 4L2 | |
| Canada, Newfoundland and Labrador | |
| Newfoundland Cancer Treatment and Research Foundation | |
| St. Johns, Newfoundland and Labrador, Canada, A1B 3V6 | |
| Canada, Nova Scotia | |
| Cape Breton Cancer Centre | |
| Sydney, Nova Scotia, Canada, B1P 1P3 | |
| Nova Scotia Cancer Centre | |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Canada, Ontario | |
| Algoma Regional Cancer Program at Sault Area Hospital | |
| Sault Sainte Marie, Ontario, Canada, P6A 2C4 | |
| Cancer Centre of Southeastern Ontario at Kingston General Hospital | |
| Kingston, Ontario, Canada, K7L 5P9 | |
| Grand River Regional Cancer Centre at Grand River Hospital | |
| Kitchner, Ontario, Canada, N2G 1G3 | |
| Humber River Regional Hospital - Weston | |
| Weston, Ontario, Canada, M9N 1N8 | |
| London Regional Cancer Program at London Health Sciences Centre | |
| London, Ontario, Canada, N6A 4L6 | |
| Male Health Centre - North York | |
| Toronto, Ontario, Canada, M6A 3B5 | |
| Male Health Centre - Oakville | |
| Oakville, Ontario, Canada, L6H 3PI | |
| Margaret and Charles Juravinski Cancer Centre | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Markham Stouffville Hospital | |
| Markham, Ontario, Canada, L6B IAI | |
| Mount Sinai Hospital - Toronto | |
| Toronto, Ontario, Canada, M5G 1X5 | |
| North York General Hospital - Ontario | |
| North York, Ontario, Canada, M2K 1E1 | |
| Northeastern Ontario Regional Cancer Centre | |
| Sudbury, Ontario, Canada, P3E 5J1 | |
| St. Joseph's Hospital | |
| Hamilton, Ontario, Canada, L8N 4A6 | |
| Ottawa Hospital Regional Cancer Centre - General Campus | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Peterborough Oncology Clinic | |
| Peterborough, Ontario, Canada, K9H 7B6 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| R. S. McLaughlin Durham Regional Cancer Centre at Lakeridge Health Oshawa | |
| Oshawa, Ontario, Canada, L1G 2B9 | |
| Royal Victoria Hospital of Barrie | |
| Barrie, Ontario, Canada, L4M 6M2 | |
| Scarborough Hospital - General Campus | |
| Scarborough, Ontario, Canada, M1P 2V5 | |
| Southlake Regional Health Centre | |
| Newmarket, Ontario, Canada, L3Y 2P9 | |
| St. Catharines General Hospital at Niagara Health System | |
| St. Catharines, Ontario, Canada, L2R 5K3 | |
| St. Joseph's Health Centre - Toronto | |
| Toronto, Ontario, Canada, M6R 1B5 | |
| Northwestern Ontario Regional Cancer Care at Thunder Bay Regional Health Sciences Centre | |
| Thunder Bay, Ontario, Canada, P7B 6V4 | |
| St. Michael's Hospital - Toronto | |
| Toronto, Ontario, Canada, M5B 1W8 | |
| Toronto East General Hospital | |
| Toronto, Ontario, Canada, M4C 3E7 | |
| Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Trillium Health Centre - Mississauga Site | |
| Mississauga, Ontario, Canada, L5B 1B8 | |
| William Osler Health Centre | |
| Brampton, Ontario, Canada, L6W 2Z8 | |
| Windsor Regional Cancer Centre at Windsor Regional Hospital | |
| Windsor, Ontario, Canada, N8W 2X3 | |
| Canada, Prince Edward Island | |
| Prince Edward Island Cancer Centre at Queen Elizabeth Hospital | |
| Charlottetown, Prince Edward Island, Canada, C1A 8T5 | |
| Canada, Quebec | |
| Centre de Sante et de Services Sociaux de Chicoutimi | |
| Chicoutimi, Quebec, Canada, G7H 5H6 | |
| Centre Hospitalier de l'Universite de Montreal | |
| Montreal, Quebec, Canada, (P.Q.) H2X 3J4 | |
| Centre Hospitalier Regional de Lanaudiere | |
| Joliette, Quebec, Canada, J6E 6J2 | |
| Centre Hospitalier Universitaire de Quebec | |
| Quebec City, Quebec, Canada, G1R 2J6 | |
| CHUS-Hopital Fleurimont | |
| Fleurimont, Quebec, Canada, J1H 5N4 | |
| Doctor Leon Richard Oncology Centre | |
| Greenfield Park, Quebec, Canada, J4V 2H1 | |
| Hopital Charles Lemoyne | |
| Greenfield Park, Quebec, Canada, J4V 2H1 | |
| Hopital Du Sacre-Coeur de Montreal | |
| Montreal, Quebec, Canada, H4J 1C5 | |
| Hopital du Saint-Sacrement - Quebec | |
| Quebec City, Quebec, Canada, G1S 4L8 | |
| Hopital Sainte Justine | |
| Montreal, Quebec, Canada, H3T 1C5 | |
| Hotel Dieu de Montreal | |
| Montreal, Quebec, Canada, H2W 1T8 | |
| Hotel-Dieu de Levis | |
| Levis, Quebec, Canada, G6V 3Z1 | |
| L'Hopital Laval | |
| Ste-Foy, Quebec, Canada, G1V 4G5 | |
| Maisonneuve-Rosemont Hospital | |
| Montreal, Quebec, Canada, H1T 2M4 | |
| Canada, Saskatchewan | |
| Allan Blair Cancer Centre at Pasqua Hospital | |
| Regina, Saskatchewan, Canada, S4T 7T1 | |
| Saskatoon Cancer Centre at the University of Saskatchewan | |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
| Study Chair: | Beryl McCormick, MD | Memorial Sloan-Kettering Cancer Center |
| Investigator: | Clifford A. Hudis, MD | Memorial Sloan-Kettering Cancer Center |
| Study Chair: | Barbara L. Smith, MD, PhD | Massachusetts General Hospital |
| Study Chair: | Timothy J. Whelan, MD | Margaret and Charles Juravinski Cancer Centre |
| Investigator: | Eileen Rakovitch, MD | Edmond Odette Cancer Centre at Sunnybrook |
More Information
| Study ID Numbers: | CDR0000067020, RTOG-9804, CAN-NCIC-MA26, CALGB-49801, RTOG-DEV-1026 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003857 History of Changes |
| Health Authority: | United States: Federal Government |
|
breast cancer in situ ductal breast carcinoma in situ |
|
Estrogen Antagonists Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Skin Diseases Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Breast Neoplasms Bone Density Conservation Agents Selective Estrogen Receptor Modulators Tamoxifen |
Pharmacologic Actions Carcinoma Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Neoplasms, Ductal, Lobular, and Medullary Adenocarcinoma Breast Diseases Neoplasms, Glandular and Epithelial |