Radiation Therapy With or Without Optional Tamoxifen in Treating Women With Ductal Carcinoma in Situ

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Cancer and Leukemia Group B
NCIC Clinical Trials Group
NRG Oncology Foundation, Inc.
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00003857
First received: November 1, 1999
Last updated: July 30, 2014
Last verified: July 2014
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Trial of Tamoxifen Alone vs. Tamoxifen Plus Radiation Therapy for Good Risk Duct Carcinoma In-Situ (DCIS) of the Female Breast

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Local recurrence (e.g., invasive or noninvasive recurrence) [ Time Frame: From randomization to date of local failure in the treated breast or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ] [ Designated as safety issue: No ]
  • Time to distant metastasis [ Time Frame: From randomization to date of distant metastasis or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ] [ Designated as safety issue: No ]
  • Invasive local recurrence [ Time Frame: From randomization to date of invasive local failure in the treated breast or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ] [ Designated as safety issue: No ]
  • Salvage mastectomy rate [ Time Frame: Analysis occurs after all patients have been potentially followed for 5 years. ] [ Designated as safety issue: No ]

Enrollment: 636
Study Start Date: December 1999
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Observation +/- tamoxifen for 5 years
Observation +/- tamoxifen 20 mg per day for 5 years
Drug: tamoxifen citrate Procedure: adjuvant therapy
Experimental: Radiation therapy +/- tamoxifen for 5 years
Radiation therapy to the whole breast +/- tamoxifen 20 mg per day for 5 years
Drug: tamoxifen citrate Procedure: adjuvant therapy Radiation: radiation therapy

Detailed Description:

OBJECTIVES:

  • Compare the efficacy of whole breast radiotherapy vs observation with or without optional tamoxifen in decreasing or delaying the appearance of local failure (both invasive and in situ) and preventing the need for mastectomy in women with good-risk ductal carcinoma in situ (DCIS) of the breast.
  • Compare distant disease-free survival of patients treated with these regimens.

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.

  • Arm I: Patients undergo observation and may receive optional oral tamoxifen once daily (at the discretion of the physician) for 5 years.
  • Arm II: Beginning within 12 weeks after final surgery, patients receive radiotherapy to the whole breast once daily, 5 days a week, for 3.5-5.5 weeks. Patients may receive optional tamoxifen as in arm I.

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
Criteria

DISEASE CHARACTERISTICS:

  • Ductal carcinoma in situ (DCIS) of the breast detected by mammogram at the time of diagnosis

    • Unicentric
    • Lesions ≤ 2.5 cm
    • Low nuclei grade (NG1) or intermediate nuclei grade (NG2) with necrosis in < one third of the involved ducts
    • Inked margins ≥ 3 mm
    • Clinically node negative
    • Non-palpable
  • No suspicious areas on post-operative mammogram taken within 12 weeks after final surgery
  • No bloody nipple discharge
  • No more than 12 weeks since prior final surgery (arm II only)
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 26 and over

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • Not pregnant or nursing
  • No active connective tissue disorders (e.g., lupus or scleroderma)
  • No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • No other concurrent hormonal therapy (e.g., raloxifene, hormone replacement therapy, or birth control pills)

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003857

  Hide Study Locations
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
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
Enloe Cancer Center at Enloe Medical Center
Chico, California, United States, 95926
Mount Diablo Regional Cancer Center
Concord, California, United States, 94524-4110
North Bay Cancer Center
Fairfield, California, United States, 94533
Washington Township Hospital
Fremont, California, United States, 94538
Saint Agnes Medical Center
Fresno, California, United States, 93720-3397
Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital
Inglewood, California, United States, 90301
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
Providence Holy Cross Cancer Center
Mission Hills, California, United States, 91346-9600
Memorial Medical Center Cancer Services
Modesto, California, United States, 95355
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
Pomona, California, United States, 91767
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, United States, 95815
University of California Davis Cancer Center
Sacramento, California, United States, 95817
CCOP - Santa Rosa Memorial Hospital
Sana Rosa, California, United States, 95405
Torrance Memorial Medical Center
Torrance, California, United States, 90509
John Muir/Mt. Diablo Comprehensive Cancer Center
Walnut Creek, California, United States, 94598
Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital
Whittier, California, United States, 90602
United States, Connecticut
St. Vincent's Medical Center
Bridgeport, Connecticut, United States, 06606
Hospital of Saint Raphael
New Haven, Connecticut, United States, 06511
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States, 06360
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
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0232
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
Lakeland, Florida, United States, 33805
Baptist-South Miami Regional Cancer Program
Miami, Florida, United States, 33176
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, Georgia
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Savannah, Georgia, United States, 31405
United States, Hawaii
Leeward Radiation Oncology Center
Ewa Beach, Hawaii, United States, 96706
Cancer Research Center of Hawaii
Honolula, Hawaii, United States, 96813
St. Francis Medical Center
Honolulu, Hawaii, United States, 96817
Queen's Cancer Institute at Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Tripler Army Medical Center
Honolulu, Hawaii, United States, 96859
United States, Idaho
St. Luke's Mountain States Tumor Institute - Boise
Boise, Idaho, United States, 83712
Hematology Oncology Associates of Eastern Idaho
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Northwest Community Hospital
Arlington Heights, Illinois, United States, 60005
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507
Good Shepherd Hospital
Barrington, Illinois, United States, 60010
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States, 60612-3785
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Creticos Cancer Center at Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States, 60657
Advocate Good Samaritan Hospital
Downers Grove, Illinois, United States, 60515
InterCommunity Cancer Center of Western Illinois
Galesburg, Illinois, United States, 61401
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Community Cancer Center
Normal, Illinois, United States, 61761
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States, 61554
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
Valley Cancer Center
Spring Valley, Illinois, United States, 61362
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
St. John's Cancer Center at St. John's Medical Center
Anderson, Indiana, United States, 46016
Regional Cancer Institute at Bloomington Hospital
Bloomington, Indiana, United States, 47403
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Parkview Regional Cancer Center at Parkview Health
Fort Wayne, Indiana, United States, 46805
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
Howard Community Hospital at Howard Regional Health System
Kokomo, Indiana, United States, 46904
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
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
Suburban Hospital
Bethesda, Maryland, United States, 20814
Peninsula Regional Medical Center
Salisbury, Maryland, United States, 21801
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States, 02118
Lahey Clinic Medical Center - Burlington
Burlington, Massachusetts, United States, 01805
Bethke Cancer Center at Emerson Hospital
Concord, Massachusetts, United States, 01742
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
Cape Cod Hospital
Hyannis, Massachusetts, United States, 02601
Lowell General Hospital
Lowell, Massachusetts, United States, 01854
Community Cancer Care at Milford Regional Medical Center
Milford, Massachusetts, United States, 01757
Caritas Norwood Hospital
Norwood, Massachusetts, United States, 02062
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
Springfield, Massachusetts, United States, 01199
United States, Michigan
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States, 49221
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States, 49431
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Great Lakes Cancer Institute at McLaren Regional Medical Center
Flint, Michigan, United States, 48532
Spectrum Health Cancer Care - Butterworth Campus
Grand Rapids, Michigan, United States, 49503
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
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
Green Bay Oncology, Limited - Iron Mountain
Iron Mountain, Michigan, United States, 49801
Foote Hospital
Jackson, Michigan, United States, 49201
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Borgess Medical Center
Kalamazooaa, Michigan, United States, 49001
Breslin Cancer Center at Ingham Regional Medical Center
Lansing, Michigan, United States, 48910
Upper Michigan Cancer Center at Marquette General Hospital
Marquette, Michigan, United States, 49855
MidMichigan Medical Center - Midland
Midland, Michigan, United States, 48670
Northern Michigan Hospital
Petoskey, Michigan, United States, 49770
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
Seton Cancer Institute - Saginaw
Saginaw, Michigan, United States, 48601
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
St. Joseph, Michigan, United States, 49085
Munson Medical Center
Traverse City, Michigan, United States, 49684
St. John Macomb Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
St. Mary's - Duluth Clinic Cancer Center
Duluth, Minnesota, United States, 55805
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Immanuel St. Joseph's Clinic
Mankato, Minnesota, United States, 56002
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale, Minnesota, United States, 55422-2900
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Coborn Cancer Center
Saint Cloud, Minnesota, United States, 56303
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
CentraCare Clinic - River Campus
St. Cloud, Minnesota, United States, 56303
Park Nicollet Health Services
St. Louis Park, Minnesota, United States, 55416
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
United Hospital
St. Paul, Minnesota, United States, 55102
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Deaconess Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
Great Falls Clinic
Great Falls, Montana, United States, 59405
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
Seacoast Cancer Center at Wentworth-Douglass Hospital
Dover, New Hampshire, United States, 03820
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
Elliot Regional Cancer Center at Elliot Hospital
Manchester, New Hampshire, United States, 03103
United States, New Jersey
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States, 07018-1095
John F. Kennedy Medical Center
Edison, New Jersey, United States, 08818
Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center
Englewood, New Jersey, United States, 07631
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740-6395
Fox Chase Virtua Health Cancer Program - Marlton
Marlton, New Jersey, United States, 08053
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08903
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
AtlantiCare Regional Medical Center
Pomona, New Jersey, United States, 08240
Booker Cancer Center at Riverview Medical Center
Red Bank, New Jersey, United States, 07701
Fox Chase Cancer Center at St. Francis Medical Center
Trenton, New Jersey, United States, 08629
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
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
Long Island College Hospital
Brooklyn, New York, United States, 11201
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
North Shore University Hospital
Manhasset, New York, United States, 11030
Tucker Center for Cancer Care at Orange Regional Medical Center
Middletown, New York, United States, 10940-4199
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
CCOP - Hematology-Oncology Associates of Central New York
Syracuse, New York, United States, 13057
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Batte Cancer Center at Northeast Medical Center
Concord, North Carolina, United States, 28025
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Wayne Radiation Oncology
Goldsboro, North Carolina, United States, 27534
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
Greenville, North Carolina, United States, 27835-6028
Pardee Memorial Hospital
Hendersonville, North Carolina, United States, 28791
Lenoir Memorial Cancer Center
Kinston, North Carolina, United States, 28501
Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst, North Carolina, United States, 28374
Rex Cancer Center at Rex Hospital
Raleigh, North Carolina, United States, 27607
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
Zimmer Cancer Center at New Hanover Regional Medical Center
Wilmington, North Carolina, United States, 28401
Wilmed Radiation Oncology Services
Wilson, North Carolina, United States, 27893
United States, North Dakota
Trinity Cancer Care Center
Minot, North Dakota, United States, 58701
United States, Ohio
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States, 44307
Mercy Cancer Center at Mercy Medical Center
Canton, Ohio, United States, 44708
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Bethesda North Hospital
Cincinnati, Ohio, United States, 45242
Cancer Treatment Center at Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210-1240
Mount Carmel Health - West Hospital
Columbus, Ohio, United States, 43222
CCOP - Columbus
Columbus, Ohio, United States, 43215
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
Lima Memorial Hospital
Lima, Ohio, United States, 45804
St. Rita's Medical Center
Lima, Ohio, United States, 45801
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Northwest Ohio Oncology Center
Maumee, Ohio, United States, 43623
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
St. Charles Mercy Hospital
Oregon, Ohio, United States, 43616
Firelands Regional Medical Center
Sandusky, Ohio, United States, 44870
Mercy Medical Center
Springfield, Ohio, United States, 45504
Promedica Cancer Center at Flower Hospital
Sylvania, Ohio, United States, 43560
Medical University of Ohio Cancer Center
Toledo, Ohio, United States, 43614
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43623
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States, 43623
St. Joseph Cancer Center at St. Joseph Health Center
Warren, Ohio, United States, 44484
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
Westerville, Ohio, United States, 43081
United States, Oklahoma
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Three Rivers Community Hospital
Grants Pass, Oregon, United States, 97527
Legacy Mount Hood Medical Center
Gresham, Oregon, United States, 97030
Providence Medford Medical Center
Medford, Oregon, United States, 97504
Dubs Cancer Center at Rogue Valley Medical Center
Medford, Oregon, United States, 97504
Providence Milwaukie Hospital
Milwaukie, Oregon, United States, 97222
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
Portland, Oregon, United States, 97210
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
Legacy Emanuel Hospital and Health Center & Children's Hospital
Portland, Oregon, United States, 97227
Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
Legacy Meridian Park Hospital
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
St. Luke's Hospital Cancer Center
Bethlehem, Pennsylvania, United States, 18015
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-0001
Mercy Fitzgerald Hospital
Darby, Pennsylvania, United States, 19023
Easton Regional Cancer Center at Easton Hospital
Easton, Pennsylvania, United States, 18042
St. Mary Regional Cancer Center
Langhorne, Pennsylvania, United States, 19047
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301-1792
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Fox Chase-Temple Cancer Center CCOP Research Base
Philadelphia, Pennsylvania, United States, 19140
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
Mercy Cancer Institute at Mercy Hospital
Pittsburgh, Pennsylvania, United States, 15219
Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, United States, 18501
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
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
Palmetto Health South Carolina Cancer Center
Columbia, South Carolina, United States, 29203
Bon Secours St. Francis Health System
Greenville, South Carolina, United States, 29601
CCOP - Greenville
Greenville, South Carolina, United States, 29615
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
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
Medical X-Ray Center, PC
Sioux Falls, South Dakota, United States, 57105
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0209
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Doctor's Hospital of Laredo
Laredo, Texas, United States, 78041
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410-1894
United States, Utah
Cottonwood Hospital Medical Center
Murray, Utah, United States, 84107
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
Dixie Regional Medical Center - East Campus
Saint George, Utah, United States, 84770
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States, 84106
LDS Hospital
Salt Lake City, Utah, United States, 84143
United States, Vermont
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States, 05401
Community Cancer Center at Rutland Regional Medical Center
Rutland, Vermont, United States, 05701
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
St. Francis Hospital
Federal Way, Washington, United States, 98003
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
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98122-4307
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Madigan Army Medical Center - Tacoma
Tacoma, Washington, United States, 98431
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, United States, 98668
United States, Wisconsin
Theda Care Cancer Institute
Appleton, Wisconsin, United States, 54911
Green Bay Oncology, Limited at St. Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
Green Bay, Wisconsin, United States, 54311
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Community Memorial Hospital Cancer Care Center
Menomonee Falls, Wisconsin, United States, 53051
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Columbia St. Mary's Cancer Care Center
Milwaukee, Wisconsin, United States, 53211
Regional Cancer Center at Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States, 53066
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, United States, 53188
West Allis Memorial Hospital
West Milwaukee, Wisconsin, United States, 53227
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
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
Nanaimo Cancer Clinic at Nanaimo Regional General Hospital
Nanaimo, British Columbia, Canada, V9S 2B7
Lions Gate Hospital
North Vancouver, British Columbia, Canada, V7L 2P9
BCCA - Fraser Valley Cancer Centre
Surrey, British Columbia, Canada, V3V 1Z2
Prostate Centre at Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 3J5
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Providence Health Care - Vancouver
Vancouver, British Columbia, Canada, V6Z 1Y6
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Victoria, British Columbia, Canada, V8R 6V5
G. Steinhoff Clinical Research
Victoria, British Columbia, Canada, V8V 3N1
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
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Cape Breton Cancer Centre
Sydney, Nova Scotia, Canada, B1P 1P3
Canada, Ontario
Royal Victoria Hospital of Barrie
Barrie, Ontario, Canada, L4M 6M2
William Osler Health Centre
Brampton, Ontario, Canada, L6W 2Z8
St. Joseph's Hospital
Hamilton, Ontario, Canada, L8N 4A6
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
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
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Markham Stouffville Hospital
Markham, Ontario, Canada, L6B IAI
Trillium Health Centre - Mississauga Site
Mississauga, Ontario, Canada, L5B 1B8
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y 2P9
North York General Hospital - Ontario
North York, Ontario, Canada, M2K 1E1
Male Health Centre - Oakville
Oakville, Ontario, Canada, L6H 3PI
R. S. McLaughlin Durham Regional Cancer Centre at Lakeridge Health Oshawa
Oshawa, Ontario, Canada, L1G 2B9
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Peterborough Oncology Clinic
Peterborough, Ontario, Canada, K9H 7B6
Algoma Regional Cancer Program at Sault Area Hospital
Sault Sainte Marie, Ontario, Canada, P6A 2C4
Scarborough Hospital - General Campus
Scarborough, Ontario, Canada, M1P 2V5
St. Catharines General Hospital at Niagara Health System
St. Catharines, Ontario, Canada, L2R 5K3
Northeastern Ontario Regional Cancer Centre
Sudbury, Ontario, Canada, P3E 5J1
Northwestern Ontario Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada, P7B 6V4
Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
St. Joseph's Health Centre - Toronto
Toronto, Ontario, Canada, M6R 1B5
Mount Sinai Hospital - Toronto
Toronto, Ontario, Canada, M5G 1X5
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Toronto East General Hospital
Toronto, Ontario, Canada, M4C 3E7
Male Health Centre - North York
Toronto, Ontario, Canada, M6A 3B5
St. Michael's Hospital - Toronto
Toronto, Ontario, Canada, M5B 1W8
Humber River Regional Hospital - Weston
Weston, Ontario, Canada, M9N 1N8
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
CHUS-Hopital Fleurimont
Fleurimont, Quebec, Canada, J1H 5N4
Hopital Charles Lemoyne
Greenfield Park, Quebec, Canada, J4V 2H1
Doctor Leon Richard Oncology Centre
Greenfield Park, Quebec, Canada, J4V 2H1
Centre Hospitalier Regional de Lanaudiere
Joliette, Quebec, Canada, J6E 6J2
Hotel-Dieu de Levis
Levis, Quebec, Canada, G6V 3Z1
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, (P.Q.) H2X 3J4
Hopital Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
Hotel Dieu de Montreal
Montreal, Quebec, Canada, H2W 1T8
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
Hopital du Saint-Sacrement - Quebec
Quebec City, Quebec, Canada, G1S 4L8
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, Canada, G1R 2J6
L'Hopital Laval
Ste-Foy, Quebec, Canada, G1V 4G5
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
Canada
Centre Hospitalier Regional de Rimouski
Quebec, Canada, G1S 4L8
Sponsors and Collaborators
Radiation Therapy Oncology Group
Cancer and Leukemia Group B
NCIC Clinical Trials Group
NRG Oncology Foundation, Inc.
Investigators
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 Odette Cancer Centre at Sunnybrook
  More Information

Additional Information:
No publications provided

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00003857     History of Changes
Other Study ID Numbers: RTOG-98-04, CDR0000067020, CAN-NCIC-MA26, CALGB-49801, RTOG-DEV-1026, NCI-2011-02038
Study First Received: November 1, 1999
Last Updated: July 30, 2014
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
breast cancer in situ
ductal breast carcinoma in situ

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Carcinoma in Situ
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Tamoxifen
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 18, 2014