AzTrials
AzTrials

Breast CancerPhase 3NCT00003857

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

A Phase 3 study testing tamoxifen citrate, adjuvant therapy and radiation therapy in people with Breast Cancer, run by Radiation Therapy Oncology Group at 369 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 26 to 120 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
tamoxifen citrate, adjuvant therapy and radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
636 participants
Where
369 sitesin 2 countries
Study dates
Dec 1999to 20 May 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 26 to 120 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

369 sites in 2 countries.

364 sites in 2 countries

United States300 sites

  • Leeward Radiation Oncology Center

    ‘Ewa Beach, Hawaii, 96706

  • Rosenfeld Cancer Center at Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Hickman Cancer Center at Bixby Medical Center

    Adrian, Michigan, 49221

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44307

  • Albuquerque Regional Medical Center at Lovelace Sandia Health System

    Albuquerque, New Mexico, 87102

  • University of New Mexico Cancer Research and Treatment Center

    Albuquerque, New Mexico, 87131-5636

  • St. John's Cancer Center at St. John's Medical Center

    Anderson, Indiana, 46016

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0942

  • DeCesaris Cancer Institute at Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • Theda Care Cancer Institute

    Appleton, Wisconsin, 54911

  • Northwest Community Hospital

    Arlington Heights, Illinois, 60005

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60507

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Good Shepherd Hospital

    Barrington, Illinois, 60010

  • Suburban Hospital

    Bethesda, Maryland, 20814

  • St. Luke's Hospital Cancer Center

    Bethlehem, Pennsylvania, 18015

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • Deaconess Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • St. Joseph Medical Center

    Bloomington, Illinois, 61701

  • Regional Cancer Institute at Bloomington Hospital

    Bloomington, Indiana, 47403

  • St. Luke's Mountain States Tumor Institute - Boise

    Boise, Idaho, 83712

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Cancer Research Center at Boston Medical Center

    Boston, Massachusetts, 02118

  • Cancer Treatment Center for Southern Kentucky

    Bowling Green, Kentucky, 42101

  • St. Vincent's Medical Center

    Bridgeport, Connecticut, 06606

  • Long Island College Hospital

    Brooklyn, New York, 11201

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Providence Saint Joseph Medical Center - Burbank

    Burbank, California, 91505

  • Lahey Clinic Medical Center - Burlington

    Burlington, Massachusetts, 01805

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont, 05401

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Mercy Cancer Center at Mercy Medical Center

    Canton, Ohio, 44708

  • St. Luke's Hospital

    Cedar Rapids, Iowa, 52402

  • Cedar Rapids Oncology Associates

    Cedar Rapids, Iowa, 52403

  • Mercy Regional Cancer Center at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7295

  • Blumenthal Cancer Center at Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Martha Jefferson Hospital Cancer Care Center

    Charlottesville, Virginia, 22901

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • John H. Stroger, Jr. Hospital of Cook County

    Chicago, Illinois, 60612-3785

  • Creticos Cancer Center at Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Enloe Cancer Center at Enloe Medical Center

    Chico, California, 95926

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Cancer Treatment Center at Good Samaritan Hospital

    Cincinnati, Ohio, 45220

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106

  • MetroHealth's Cancer Care Center at MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • Palmetto Health South Carolina Cancer Center

    Columbia, South Carolina, 29203

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

    Columbus, Ohio, 43210-1240

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214-3998

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Mount Carmel Health - West Hospital

    Columbus, Ohio, 43222

  • Mount Diablo Regional Cancer Center

    Concord, California, 94524-4110

  • Bethke Cancer Center at Emerson Hospital

    Concord, Massachusetts, 01742

  • Dartmouth - Hitchcock Concord

    Concord, New Hampshire, 03301

  • Batte Cancer Center at Northeast Medical Center

    Concord, North Carolina, 28025

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-0001

  • Mercy Fitzgerald Hospital

    Darby, Pennsylvania, 19023

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Seacoast Cancer Center at Wentworth-Douglass Hospital

    Dover, New Hampshire, 03820

  • Advocate Good Samaritan Hospital

    Downers Grove, Illinois, 60515

  • St. Mary's - Duluth Clinic Cancer Center

    Duluth, Minnesota, 55805

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Veterans Affairs Medical Center - East Orange

    East Orange, New Jersey, 07018-1095

  • Easton Regional Cancer Center at Easton Hospital

    Easton, Pennsylvania, 18042

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • John F. Kennedy Medical Center

    Edison, New Jersey, 08818

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • Green Bay Oncology, Limited - Escanaba

    Escanaba, Michigan, 49431

  • Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

  • North Bay Cancer Center

    Fairfield, California, 94533

  • Hudner Oncology Center at Saint Anne's Hospital

    Fall River, Massachusetts, 02721

  • St. Francis Hospital

    Federal Way, Washington, 98003

  • Blanchard Valley Medical Associates

    Findlay, Ohio, 45840

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Great Lakes Cancer Institute at McLaren Regional Medical Center

    Flint, Michigan, 48532

  • Parkview Regional Cancer Center at Parkview Health

    Fort Wayne, Indiana, 46805

  • MetroWest Medical Center - Framingham Union Hospital

    Framingham, Massachusetts, 01702

  • Washington Township Hospital

    Fremont, California, 94538

  • Saint Agnes Medical Center

    Fresno, California, 93720-3397

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610-0232

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • InterCommunity Cancer Center of Western Illinois

    Galesburg, Illinois, 61401

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0209

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Wayne Radiation Oncology

    Goldsboro, North Carolina, 27534

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Mercy Medical Center

    Grand Rapids, Michigan, 49503

  • Spectrum Health Cancer Care - Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Three Rivers Community Hospital

    Grants Pass, Oregon, 97527

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Green Bay Oncology, Limited at St. Vincent Hospital

    Green Bay, Wisconsin, 54301-3526

  • Green Bay Oncology, Limited at St. Mary's Hospital

    Green Bay, Wisconsin, 54303

  • St. Mary's Hospital Medical Center - Green Bay

    Green Bay, Wisconsin, 54303

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital

    Greenville, North Carolina, 27835-6028

  • Bon Secours St. Francis Health System

    Greenville, South Carolina, 29601

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • Queen's Cancer Institute at Queen's Medical Center

    Honolulu, Hawaii, 96813

  • St. Francis Medical Center

    Honolulu, Hawaii, 96817

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859

  • Saint Joseph's Mercy Cancer Center

    Hot Springs, Arkansas, 71913

  • M.D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

  • Cape Cod Hospital

    Hyannis, Massachusetts, 02601

  • Hematology Oncology Associates of Eastern Idaho

    Idaho Falls, Idaho, 83404

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5289

  • Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital

    Inglewood, California, 90301

  • Green Bay Oncology, Limited - Iron Mountain

    Iron Mountain, Michigan, 49801

  • Foote Hospital

    Jackson, Michigan, 49201

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Joliet Oncology-Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Good Samaritan Cancer Center at Good Samaritan Hospital

    Kearney, Nebraska, 68848-1990

  • Lenoir Memorial Cancer Center

    Kinston, North Carolina, 28501

  • Cascade Cancer Center at Evergreen Hospital Medical Center

    Kirkland, Washington, 98033

  • Howard Community Hospital at Howard Regional Health System

    Kokomo, Indiana, 46904

  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • Lakeland Regional Cancer Center at Lakeland Regional Medical Center

    Lakeland, Florida, 33805

  • St. Mary Regional Cancer Center

    Langhorne, Pennsylvania, 19047

  • Breslin Cancer Center at Ingham Regional Medical Center

    Lansing, Michigan, 48910

  • Doctor's Hospital of Laredo

    Laredo, Texas, 78041

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • Central Maine Medical Center

    Lewiston, Maine, 04240

  • Central Baptist Hospital

    Lexington, Kentucky, 40503-9985

  • St. Rita's Medical Center

    Lima, Ohio, 45801

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740-6395

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90089-9181

  • Lowell General Hospital

    Lowell, Massachusetts, 01854

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79410-1894

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County

    Madisonville, Kentucky, 42431

  • Elliot Regional Cancer Center at Elliot Hospital

    Manchester, New Hampshire, 03103

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Immanuel St. Joseph's Clinic

    Mankato, Minnesota, 56002

  • Strecker Cancer Center at Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Bay Area Cancer Care Center at Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Fox Chase Virtua Health Cancer Program - Marlton

    Marlton, New Jersey, 08053

  • Upper Michigan Cancer Center at Marquette General Hospital

    Marquette, Michigan, 49855

  • Northwest Ohio Oncology Center

    Maumee, Ohio, 43623

  • Hillcrest Cancer Center at Hillcrest Hospital

    Mayfield Heights, Ohio, 44124

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • Dubs Cancer Center at Rogue Valley Medical Center

    Medford, Oregon, 97504

  • Providence Medford Medical Center

    Medford, Oregon, 97504

  • Community Memorial Hospital Cancer Care Center

    Menomonee Falls, Wisconsin, 53051

  • University of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Baptist-South Miami Regional Cancer Program

    Miami, Florida, 33176

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • Tucker Center for Cancer Care at Orange Regional Medical Center

    Middletown, New York, 10940-4199

  • MidMichigan Medical Center - Midland

    Midland, Michigan, 48670

  • Community Cancer Care at Milford Regional Medical Center

    Milford, Massachusetts, 01757

  • Columbia St. Mary's Cancer Care Center

    Milwaukee, Wisconsin, 53211

  • Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Providence Milwaukie Hospital

    Milwaukie, Oregon, 97222

  • Virginia Piper Cancer Institute at Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Trinity Cancer Care Center

    Minot, North Dakota, 58701

  • Providence Holy Cross Cancer Center

    Mission Hills, California, 91346-9600

  • Mobile Infirmary Medical Center

    Mobile, Alabama, 36652-2144

  • Memorial Medical Center Cancer Services

    Modesto, California, 95355

  • Cottonwood Hospital Medical Center

    Murray, Utah, 84107

  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08903

  • Saint Peter's University Hospital

    New Brunswick, New Jersey, 08903

  • Hospital of Saint Raphael

    New Haven, Connecticut, 06511

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11042

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Licking Memorial Cancer Care Program at Licking Memorial Hospital

    Newark, Ohio, 43055

  • BroMenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center

    Normal, Illinois, 61761

  • Eastern Connecticut Hematology and Oncology Associates

    Norwich, Connecticut, 06360

  • Caritas Norwood Hospital

    Norwood, Massachusetts, 02062

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609

  • Regional Cancer Center at Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066

  • Green Bay Oncology, Limited - Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Methodist Cancer Center at Methodist Hospital - Omaha

    Omaha, Nebraska, 68114

  • St. Charles Mercy Hospital

    Oregon, Ohio, 43616

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301-1792

  • Lutheran General Cancer Care Center

    Park Ridge, Illinois, 60068

  • Cancer Treatment Center at Pekin Hospital

    Pekin, Illinois, 61554

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615

  • Oncology Hematology Associates of Central Illinois, PC - Peoria

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61637

  • Northern Michigan Hospital

    Petoskey, Michigan, 49770

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Fox Chase-Temple Cancer Center CCOP Research Base

    Philadelphia, Pennsylvania, 19140

  • Arizona Oncology Services Foundation

    Phoenix, Arizona, 85013

  • Moore Regional Community Hospital Comprehensive Cancer Center

    Pinehurst, North Carolina, 28374

  • Mercy Cancer Institute at Mercy Hospital

    Pittsburgh, Pennsylvania, 15219

  • Hillman Cancer Center at University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15232

  • Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center

    Pomona, California, 91767

  • AtlantiCare Regional Medical Center

    Pomona, New Jersey, 08240

  • Maine Medical Center - Bramhall Campus

    Portland, Maine, 04102

  • Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center

    Portland, Oregon, 97210

  • Providence Cancer Center at Providence Portland Medical Center

    Portland, Oregon, 97213-2967

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Legacy Emanuel Hospital and Health Center & Children's Hospital

    Portland, Oregon, 97227

  • Cancer Institute at Oregon Health and Science University

    Portland, Oregon, 97239-3098

  • Naval Medical Center - Portsmouth

    Portsmouth, Virginia, 23708-2197

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84604

  • Rex Cancer Center at Rex Hospital

    Raleigh, North Carolina, 27607

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Reading Hospital and Medical Center

    Reading, Pennsylvania, 19612-6052

  • Booker Cancer Center at Riverview Medical Center

    Red Bank, New Jersey, 07701

  • Hubert H. Humphrey Cancer Center at North Memorial Medical Center

    Robbinsdale, Minnesota, 55422-2900

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • William Beaumont Hospital - Royal Oak Campus

    Royal Oak, Michigan, 48073

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • Community Cancer Center at Rutland Regional Medical Center

    Rutland, Vermont, 05701

  • Radiological Associates of Sacramento Medical Group, Incorporated

    Sacramento, California, 95815

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Seton Cancer Institute - Saginaw

    Saginaw, Michigan, 48601

  • CentraCare Clinic - River Campus

    Saint Cloud, Minnesota, 56303

  • Coborn Cancer Center

    Saint Cloud, Minnesota, 56303

  • Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph

    Saint Joseph, Michigan, 49085

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Health Services

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital Cancer Care Center

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Peninsula Regional Medical Center

    Salisbury, Maryland, 21801

  • Utah Cancer Specialists at UCS Cancer Center

    Salt Lake City, Utah, 84106

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • Firelands Regional Medical Center

    Sandusky, Ohio, 44870

  • CCOP - Santa Rosa Memorial Hospital

    Santa Rosa, California, 95405

  • Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler

    Savannah, Georgia, 31405

  • Mercy Hospital Cancer Center - Scranton

    Scranton, Pennsylvania, 18501

  • CCOP - Virginia Mason Research Center

    Seattle, Washington, 98101

  • Group Health Central Hospital

    Seattle, Washington, 98112

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98122-4307

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195-6043

  • Medical X-Ray Center, PC

    Sioux Falls, South Dakota, 57105

  • Sioux Valley Hospital and University of South Dakota Medical Center

    Sioux Falls, South Dakota, 57117-5039

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Valley Cancer Center

    Spring Valley, Illinois, 61362

  • Baystate Regional Cancer Program at D'Amour Center for Cancer Care

    Springfield, Massachusetts, 01199

  • Mercy Medical Center

    Springfield, Ohio, 45504

  • Dixie Regional Medical Center - East Campus

    St. George, Utah, 84770

  • Mount Nittany Medical Center

    State College, Pennsylvania, 16803

  • Green Bay Oncology, Limited - Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235

  • Promedica Cancer Center at Flower Hospital

    Sylvania, Ohio, 43560

  • CCOP - Hematology-Oncology Associates of Central New York

    Syracuse, New York, 13057

  • Madigan Army Medical Center - Tacoma

    Tacoma, Washington, 98431

  • St. Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • Medical University of Ohio Cancer Center

    Toledo, Ohio, 43614

  • CCOP - Toledo Community Hospital

    Toledo, Ohio, 43623

  • Toledo Clinic, Incorporated - Main Clinic

    Toledo, Ohio, 43623

  • Stormont-Vail Cancer Center

    Topeka, Kansas, 66604

  • St. Francis Comprehensive Cancer Center

    Topeka, Kansas, 66606

  • Torrance Memorial Medical Center

    Torrance, California, 90509

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Fox Chase Cancer Center at St. Francis Medical Center

    Trenton, New Jersey, 08629

  • Legacy Meridian Park Hospital

    Tualatin, Oregon, 97062

  • Natalie Warren Bryant Cancer Center at St. Francis Hospital

    Tulsa, Oklahoma, 74136

  • Carle Cancer Center at Carle Foundation Hospital

    Urbana, Illinois, 61801

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Southwest Washington Medical Center Cancer Center

    Vancouver, Washington, 98668

  • Cancer Institute of New Jersey at Cooper - Voorhees

    Voorhees Township, New Jersey, 08043

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • John Muir/Mt. Diablo Comprehensive Cancer Center

    Walnut Creek, California, 94598

  • St. John Macomb Hospital

    Warren, Michigan, 48093

  • St. Joseph Cancer Center at St. Joseph Health Center

    Warren, Ohio, 44484

  • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Waukesha Memorial Hospital Regional Cancer Center

    Waukesha, Wisconsin, 53188

  • West Allis Memorial Hospital

    West Milwaukee, Wisconsin, 53227

  • Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital

    Westerville, Ohio, 43081

  • Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital

    Whittier, California, 90602

  • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

    Wilkes-Barre, Pennsylvania, 18711

Other trials in United States

Canada64 sites

  • Royal Victoria Hospital of Barrie

    Barrie, Ontario, L4M 6M2

  • William Osler Health Centre

    Brampton, Ontario, L6W 2Z8

  • Prince Edward Island Cancer Centre at Queen Elizabeth Hospital

    Charlottetown, Prince Edward Island, C1A 8T5

  • Centre de Sante et de Services Sociaux de Chicoutimi

    Chicoutimi, Quebec, G7H 5H6

  • Cross Cancer Institute at University of Alberta

    Edmonton, Alberta, T6G 1Z2

  • CHUS-Hopital Fleurimont

    Fleurimont, Quebec, J1H 5N4

  • Northeastern Ontario Regional Cancer Centre

    Greater Sudbury, Ontario, P3E 5J1

  • Doctor Leon Richard Oncology Centre

    Greenfield Park, Quebec, J4V 2H1

  • Hopital Charles Lemoyne

    Greenfield Park, Quebec, J4V 2H1

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • St. Joseph's Hospital

    Hamilton, Ontario, L8N 4A6

  • Margaret and Charles Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • Centre Hospitalier Regional de Lanaudiere

    Joliette, Quebec, J6E 6J2

  • British Columbia Cancer Agency - Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • Cancer Centre of Southeastern Ontario at Kingston General Hospital

    Kingston, Ontario, K7L 5P9

  • Grand River Regional Cancer Centre at Grand River Hospital

    Kitchner, Ontario, N2G 1G3

  • Lethbridge Cancer Centre

    Lethbridge, Alberta, T1J 1W5

  • Hotel-Dieu de Levis

    Lévis, Quebec, G6V 3Z1

  • London Regional Cancer Program at London Health Sciences Centre

    London, Ontario, N6A 4L6

  • Markham Stouffville Hospital

    Markham, Ontario, L6B IAI

  • Trillium Health Centre - Mississauga Site

    Mississauga, Ontario, L5B 1B8

  • Moncton Hospital

    Moncton, New Brunswick, E1C 6ZB

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, (P.Q.) H2X 3J4

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec, H1T 2M4

  • Hotel Dieu de Montreal

    Montreal, Quebec, H2W 1T8

  • Hopital Sainte Justine

    Montreal, Quebec, H3T 1C5

  • Hopital Du Sacre-Coeur de Montreal

    Montreal, Quebec, H4J 1C5

  • Nanaimo Cancer Clinic at Nanaimo Regional General Hospital

    Nanaimo, British Columbia, V9S 2B7

  • Southlake Regional Health Centre

    Newmarket, Ontario, L3Y 2P9

  • Lions Gate Hospital

    North Vancouver, British Columbia, V7L 2P9

  • North York General Hospital - Ontario

    North York, Ontario, M2K 1E1

  • Male Health Centre - Oakville

    Oakville, Ontario, L6H 3PI

  • R. S. McLaughlin Durham Regional Cancer Centre at Lakeridge Health Oshawa

    Oshawa, Ontario, L1G 2B9

  • Ottawa Hospital Regional Cancer Centre - General Campus

    Ottawa, Ontario, K1H 8L6

  • Peterborough Oncology Clinic

    Peterborough, Ontario, K9H 7B6

  • Centre Hospitalier Universitaire de Quebec

    Québec, Quebec, G1R 2J6

  • Hopital du Saint-Sacrement - Quebec

    Québec, Quebec, G1S 4L8

  • Centre Hospitalier Regional de Rimouski

    Québec, G1S 4L8

  • Allan Blair Cancer Centre at Pasqua Hospital

    Regina, Saskatchewan, S4T 7T1

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Saskatoon Cancer Centre at the University of Saskatchewan

    Saskatoon, Saskatchewan, S7N 4H4

  • Algoma Regional Cancer Program at Sault Area Hospital

    Sault Ste. Marie, Ontario, P6A 2C4

  • Scarborough Hospital - General Campus

    Scarborough Village, Ontario, M1P 2V5

  • St. Catharines General Hospital at Niagara Health System

    St. Catharines, Ontario, L2R 5K3

  • Newfoundland Cancer Treatment and Research Foundation

    St. John's, Newfoundland and Labrador, A1B 3V6

  • L'Hopital Laval

    Ste-Foy, Quebec, G1V 4G5

  • BCCA - Fraser Valley Cancer Centre

    Surrey, British Columbia, V3V 1Z2

  • Cape Breton Cancer Centre

    Sydney, Nova Scotia, B1P 1P3

  • Northwestern Ontario Regional Cancer Care at Thunder Bay Regional Health Sciences Centre

    Thunder Bay, Ontario, P7B 6V4

  • Toronto East General Hospital

    Toronto, Ontario, M4C 3E7

  • Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • St. Michael's Hospital - Toronto

    Toronto, Ontario, M5B 1W8

  • Mount Sinai Hospital - Toronto

    Toronto, Ontario, M5G 1X5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • Male Health Centre - North York

    Toronto, Ontario, M6A 3B5

  • St. Joseph's Health Centre - Toronto

    Toronto, Ontario, M6R 1B5

  • Prostate Centre at Vancouver General Hospital

    Vancouver, British Columbia, V5Z 3J5

  • British Columbia Cancer Agency - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

  • Providence Health Care - Vancouver

    Vancouver, British Columbia, V6Z 1Y6

  • British Columbia Cancer Agency - Vancouver Island Cancer Centre

    Victoria, British Columbia, V8R 6V5

  • G. Steinhoff Clinical Research

    Victoria, British Columbia, V8V 3N1

  • Humber River Regional Hospital - Weston

    Weston, Ontario, M9N 1N8

  • Windsor Regional Cancer Centre at Windsor Regional Hospital

    Windsor, Ontario, N8W 2X3

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

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

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.

Read the 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.

Conditions
Breast Cancer
Being tested
tamoxifen citrate, adjuvant therapy, radiation therapy
Keywords
breast cancer in situ, ductal breast carcinoma in situ
Medical subject headings
Breast Neoplasms, Breast Carcinoma In Situ, Carcinoma, Intraductal, Noninfiltrating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tamoxifen citrateDrug

  • adjuvant therapyProcedure or surgery

  • radiation therapyRadiation

Study groups in NCT00003857
Study groupRoleWhat they receive
Observation +/- tamoxifen for 5 yearsActive comparatorObservation +/- tamoxifen 20 mg per day for 5 years
Receives: Drug: tamoxifen citrate; Procedure: adjuvant therapy
Radiation therapy +/- tamoxifen for 5 yearsExperimentalRadiation therapy to the whole breast +/- tamoxifen 20 mg per day for 5 years
Receives: Drug: tamoxifen citrate; Procedure: adjuvant therapy; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Local recurrence (e.g., invasive or noninvasive recurrence)

    Measured: 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.

Secondary outcomes (4)

  1. Overall survival

    Measured: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.

  2. Time to distant metastasis

    Measured: From randomization to date of distant metastasis or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.

  3. Invasive local recurrence

    Measured: 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.

  4. Salvage mastectomy rate

    Measured: Analysis occurs after all patients have been potentially followed for 5 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startDec 1999
  3. Primary completionFeb 2004
  4. Study completion20 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
636 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003857
Sponsor's protocol ID
RTOG-9804
Other IDs
CDR0000067020, CAN-NCIC-MA26, CALGB-49801, NCI-2011-02038
Status last verified
May 2022
First submitted
1 Nov 1999
Last updated
25 May 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • McCormick B, Winter K, Hudis C, Kuerer HM, Rakovitch E, Smith BL, Sneige N, Moughan J, Shah A, Germain I, Hartford AC, Rashtian A, Walker EM, Yuen A, Strom EA, Wilcox JL, Vallow LA, Small W Jr, Pu AT, Kerlin K, White J. RTOG 9804: a prospective randomized trial for good-risk ductal carcinoma in situ comparing radiotherapy with observation. J Clin Oncol. 2015 Mar 1;33(7):709-15. doi: 10.1200/JCO.2014.57.9029. Epub 2015 Jan 20.

    PubMed 25605856

  • McCormick B, Winter KA, Woodward W, Kuerer HM, Sneige N, Rakovitch E, Smith BL, Germain I, Hartford AC, O'Rourke MA, Walker EM, Strom EA, Hopkins JO, Pierce LJ, Pu AT, Sumida KNM, Vesprini D, Moughan J, White JR. Randomized Phase III Trial Evaluating Radiation Following Surgical Excision for Good-Risk Ductal Carcinoma In Situ: Long-Term Report From NRG Oncology/RTOG 9804. J Clin Oncol. 2021 Nov 10;39(32):3574-3582. doi: 10.1200/JCO.21.01083. Epub 2021 Aug 18.

    PubMed 34406870

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing tamoxifen citrate, adjuvant therapy and radiation therapy in people with Breast Cancer, run by Radiation Therapy Oncology Group at 369 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 369 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003857, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.

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