AzTrials
AzTrials

Breast CancerPhase 3NCT00053898

Anastrozole or Tamoxifen in Treating Postmenopausal Women With Ductal Carcinoma in Situ Who Are Undergoing Lumpectomy and Radiation Therapy

A Phase 3 study testing anastrozole, tamoxifen citrate and Radiation Therapy in people with Breast Cancer, run by NSABP Foundation Inc at 740 sites in 3 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: Estrogen can stimulate the growth of breast cancer cells. Tamoxifen may fight breast cancer by blocking the use of estrogen. Anastrozole may fight breast cancer by decreasing estrogen production. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Breast Cancer
What is being tested?
anastrozole, tamoxifen citrate and Radiation Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,104 participants
Where
740 sitesin 3 countries
Study dates
Jan 2003to May 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed ductal carcinoma in situ (DCIS) of the breast
  • Mixed DCIS and lobular carcinoma in situ (LCIS) allowed
  • Must have undergone lumpectomy
  • Margins must be histologically free of disease
  • Re-excision to obtain tumor-free margins allowed
  • No more than 84 days since prior lumpectomy or re-excision
  • More than 1 area of DCIS allowed provided all disease is removed with tumor-free margins
  • Masses or clusters of calcification that are clinically or mammographically suspicious must be biopsied
  • No prior invasive breast cancer or DCIS
  • Patients with a history of LCIS are eligible
  • No prior or concurrent invasive (including microinvasive) breast cancer
  • DCIS "suspicious" for microinvasion allowed
  • No bilateral malignancy
  • No mass or mammographic abnormality suspicious for malignancy in the opposite breast unless not malignant as proven by biopsy
  • No Paget's disease of the nipple
  • No positive ipsilateral axillary or intramammary nodes
  • No palpable nodes in the ipsilateral or contralateral axilla or palpable supraclavicular or infraclavicular nodes unless not involved with tumor as proven by biopsy
  • Hormone receptor status:
  • Estrogen- or progesterone-receptor positive as determined by immunohistochemistry
  • Borderline results are considered positive

PATIENT CHARACTERISTICS:

Age

  • See Menopausal status

Sex:

  • Female

Menopausal status:

  • Postmenopausal as defined by at least 1 of the following:
  • Prior documented bilateral oophorectomy
  • At least 12 months without spontaneous bleeding
  • Age 55 or over with prior hysterectomy without oophorectomy
  • Age 54 or under with prior hysterectomy without oophorectomy with a documented follicle-stimulating hormone level in the postmenopausal range

Performance status

  • Zubrod 0-2

Life expectancy

  • At least 10 years (excluding diagnosis of breast cancer)

Hematopoietic

  • WBC normal

Hepatic

  • AST normal
  • Bilirubin normal
  • Alkaline phosphatase normal
  • No hepatic disease that would preclude administration of study drugs

Renal

  • Creatinine normal
  • No renal disease that would preclude administration of study drugs

Cardiovascular

  • No prior documented cerebral vascular accident or transient ischemic attack
  • No prior deep vein thrombosis
  • No cardiovascular disease that would preclude administration of study drugs
  • No uncontrolled hypertension (i.e., systolic blood pressure at least 180 mm Hg or diastolic blood pressure at least 110 mm Hg based on the average of 2 or more readings at each of 2 or more visits after initial screening)
  • No uncontrolled atrial fibrillation

Pulmonary

  • No pulmonary embolus

Other

  • Not pregnant or nursing
  • Patients with a history of non-breast malignancies are eligible provided they have been disease-free for ≥ 5 years and are deemed by their physician to be at low risk for recurrence
  • No other malignancy within the past 5 years except treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the colon, or melanoma in situ
  • No psychiatric or addictive disorders that would preclude informed consent
  • No uncontrolled diabetes, defined as hemoglobin A1C greater than 9% (fasting glucose 200 mg/dL)
  • No nonmalignant systemic disease that would preclude administration of study drugs

PRIOR CONCURRENT THERAPY:

Endocrine therapy

  • No prior or concurrent aromatase inhibitors (e.g., exemestane or letrozole) or tamoxifen
  • No concurrent raloxifene or other selective estrogen receptor modulators
  • No concurrent sex hormone therapy (e.g., estrogen or progesterone replacement therapy, oral contraceptives, androgens, luteinizing hormone releasing hormone analogs, prolactin inhibitors, or antiandrogens)
  • Low-dose estrogen vaginal creams or Estring allowed

Radiotherapy

  • Radiotherapy for this cancer initiated before study is allowed

Surgery

  • See Disease Characteristics
  • No prior or concurrent mastectomy for DCIS
  • Prior sentinel node biopsy or axillary node dissection allowed provided nodes are pathologically negative

Other

  • No concurrent warfarin
  • No other systemic therapy for this cancer initiated before study
  • No other concurrent anticancer therapy unless permitted by the protocol investigator
  • No concurrent participation in another clinical trial of therapy for DCIS
  • Concurrent participation in protocol NSABP-B-39 allowed

Trial locations and contacts

740 sites in 3 countries.

316 sites in 3 countries

United States300 sites

  • Rosenfeld Cancer Center at Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Hickman Cancer Center at Bixby Medical Center

    Adrian, Michigan, 49221

  • Cancer Care Institute of Carolina at Aiken Regional Medical Centers

    Aiken, South Carolina, 29801

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44307

  • Akron City Hospital

    Akron, Ohio, 44309-2090

  • Phoebe Cancer Center at Phoebe Putney Memorial Hospital

    Albany, Georgia, 31701

  • Albany Medical Center Hospital

    Albany, New York, 12208

  • New York Oncology Hematology, PC at Albany Regional Cancer Care

    Albany, New York, 12208

  • Albert Lea Cancer Center at Albert Lea Medical Center

    Albert Lea, Minnesota, 56007

  • Hematology Oncology Associates, PC

    Albuquerque, New Mexico, 87106

  • Lovelace Medical Center

    Albuquerque, New Mexico, 87108

  • University of New Mexico Cancer Research and Treatment Center

    Albuquerque, New Mexico, 87131-5636

  • Sacred Heart Hospital

    Allentown, Pennsylvania, 18102

  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

    Allentown, Pennsylvania, 18105

  • Saint Anthony's Hospital at Saint Anthony's Health Center

    Alton, Illinois, 62002

  • McFarland Clinic, P. C.

    Ames, Iowa, 50010

  • Amsterdam Community Cancer Program

    Amsterdam, New York, 12010

  • Cancer Center at Providence Alaska Medical Center

    Anchorage, Alaska, 99519-6604

  • 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

  • Northeast Alabama Regional Medical Center

    Anniston, Alabama, 36202

  • Fox Valley Surgical Associates at Appleton Medical Center

    Appleton, Wisconsin, 54911

  • Theda Care Cancer Institute

    Appleton, Wisconsin, 54911

  • Hope A Women's Cancer Center

    Asheville, North Carolina, 28801

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina, 28801

  • Cancer Resource Center at King's Daughters Medical Center

    Ashland, Kentucky, 41101

  • Northeast Georgia Cancer Care, LLC

    Athens, Georgia, 30607

  • Emory Crawford Long Hospital

    Atlanta, Georgia, 30308

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • Northside Hospital Cancer Center

    Atlanta, Georgia, 30342-1611

  • Saint Joseph's Hospital of Atlanta

    Atlanta, Georgia, 30342-1701

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342

  • Sturdy Memorial Hospital

    Attleboro, Massachusetts, 02703

  • Auburn Regional Center for Cancer Care

    Auburn, Washington, 98002

  • Augusta Oncology Associates - Walton Way

    Augusta, Georgia, 30901

  • MBCCOP-Medical College of Georgia Cancer Center

    Augusta, Georgia, 30912

  • Aurora Presbyterian Hospital

    Aurora, Colorado, 80012

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60507

  • WellStar Cobb Hospital

    Austell, Georgia, 30106

  • Seton Shivers Cancer Program at Brackenridge Hospital

    Austin, Texas, 78701

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • St. Agnes Cancer Center

    Baltimore, Maryland, 21229

  • Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center

    Baltimore, Maryland, 21237

  • CancerCare of Maine at Eastern Maine Medial Center

    Bangor, Maine, 04401

  • Ochsner Clinic of Baton Rouge

    Baton Rouge, Louisiana, 708169990

  • Battle Creek Health System Cancer Care Center

    Battle Creek, Michigan, 49017

  • Bay Regional Medical Center

    Bay City, Michigan, 48708

  • St. Francis Hospital and Health Centers - Beech Grove Campus

    Beech Grove, Indiana, 46107

  • Overlake Cancer Center at Overtake Hospital Medical Center

    Bellevue, Washington, 98004

  • St. Joseph Hospital Community Cancer Center

    Bellingham, Washington, 98225

  • MeritCare Clinic - Bemidji

    Bemidji, Minnesota, 56601

  • St. Charles Medical Center - Bend

    Bend, Oregon, 97701

  • Green Mountain Oncology Group

    Bennington, Vermont, 05201

  • Southwestern Vermont Regional Cancer Center

    Bennington, Vermont, 05201

  • Alta Bates Comprehensive Cancer Center

    Berkeley, California, 94704

  • Mountainview Medical

    Berlin Corners, Vermont, 05602

  • Suburban Hospital

    Bethesda, Maryland, 20814

  • National Naval Medical Center

    Bethesda, Maryland, 20889

  • St. Luke's Hospital Cancer Center

    Bethlehem, Pennsylvania, 18015

  • Mecosta County Medical Center

    Big Rapids, Michigan, 49307

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • Deaconess Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Comprehensive Cancer Center at University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Bismarck Cancer Center

    Bismarck, North Dakota, 58501

  • Cancer Care Center at Medcenter One Hospital

    Bismarck, North Dakota, 58501

  • Mid Dakota Clinic, P. C.

    Bismarck, North Dakota, 58501

  • St. Alexius Medical Center

    Bismarck, North Dakota, 58502

  • St. Joseph Medical Center

    Bloomington, Illinois, 61701

  • Regional Cancer Institute at Bloomington Hospital

    Bloomington, Indiana, 47403

  • Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center

    Boca Raton, Florida, 33486

  • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

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

    Boise, Idaho, 83712

  • Tufts - New England Medical Center

    Boston, Massachusetts, 02111

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

    Boston, Massachusetts, 02115

  • Cancer Research Center at Boston Medical Center

    Boston, Massachusetts, 02118

  • Caritas St. Elizabeth's Medical Center

    Boston, Massachusetts, 02135-2997

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Boulder Community Hospital

    Boulder, Colorado, 80301-9019

  • Ocean Medical Center at Meridian Health

    Brick, New Jersey, 08724

  • Bridgeport Hospital

    Bridgeport, Connecticut, 06610

  • St. Joseph Regional Cancer Center

    Bryan, Texas, 77802

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Providence Saint Joseph Medical Center - Burbank

    Burbank, California, 91505

  • Peninsula Medical Center

    Burlingame, California, 94010

  • Lahey Clinic Medical Center - Burlington

    Burlington, Massachusetts, 01805

  • Alamance Cancer Center

    Burlington, North Carolina, 27216

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont, 05401

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Graham Hospital

    Canton, Illinois, 61520

  • Mercy Cancer Center at Mercy Medical Center

    Canton, Ohio, 44708

  • Aultman Hospital Cancer Center at Aultman Health Foundation

    Canton, Ohio, 44710-1799

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63701

  • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital

    Cape Girardeau, Missouri, 63701

  • Carson-Tahoe Cancer Services at Carson Tahoe Regional Healthcare

    Carson City, Nevada, 89703

  • Memorial Hospital

    Carthage, Illinois, 62321

  • Iowa Blood and Cancer Care

    Cedar Rapids, Iowa, 52402

  • 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

  • Providence Centralia Hospital Regional Cancer Center

    Centralia, Washington, 98531-9027

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

    Chapel Hill, North Carolina, 27599-7295

  • Roper St. Francis Cancer Center at Roper Hospital

    Charleston, South Carolina, 29401

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division

    Charleston, West Virginia, 25304

  • Blumenthal Cancer Center at Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • Martha Jefferson Hospital Cancer Care Center

    Charlottesville, Virginia, 22901

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Erlanger Cancer Center

    Chattanooga, Tennessee, 37403

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Mercy Hospital and Medical Center

    Chicago, Illinois, 60616

  • Swedish Covenant Hospital

    Chicago, Illinois, 60625

  • Resurrection Medical Center

    Chicago, Illinois, 60631

  • Creticos Cancer Center at Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Christ Hospital Cancer Center

    Cincinnati, Ohio, 45219

  • Cancer Treatment Center at Good Samaritan Hospital

    Cincinnati, Ohio, 45220

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • Oncology Hematology Care, Incorporated - Blue Ash

    Cincinnati, Ohio, 45242

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106

  • MetroHealth's Cancer Care Center at MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Cleveland Clinic Cancer Center at Fairview Hospital

    Cleveland, Ohio, 44111

  • Huron Hospital Cancer Care Center

    Cleveland, Ohio, 44112

  • Euclid Hospital

    Cleveland, Ohio, 44119

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Memorial Hospital

    Colorado Springs, Colorado, 80909

  • Penrose Cancer Center at Penrose Hospital

    Colorado Springs, Colorado, 80933

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • John B. Amos Community Cancer Center

    Columbus, Georgia, 31904

  • 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

  • Grant Riverside Cancer Services

    Columbus, Ohio, 43215

  • Mount Carmel West Hospital

    Columbus, Ohio, 43222

  • Doctors Hospital at Ohio Health

    Columbus, Ohio, 43228

  • Mount Diablo Regional Cancer Center

    Concord, California, 94524-4110

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Presbyterian Hospital of Dallas

    Dallas, Texas, 75231

  • Baylor University Medical Center - Dallas

    Dallas, Texas, 75246

  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

    Dallas, Texas, 75390

  • Praxair Cancer Center at Danbury Hospital

    Danbury, Connecticut, 06810

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-0001

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Genesis Regional Cancer Center at Genesis Medical Center

    Davenport, Iowa, 52803

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital

    Dayton, Ohio, 45406

  • Samaritan North Cancer Care Center

    Dayton, Ohio, 45415

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • Halifax Medical Center

    Daytona Beach, Florida, 32115

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • Charles B. Eberhart Cancer Center at DeKalb Medical Center

    Decatur, Georgia, 30033

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Presbyterian - St. Luke's Medical Center

    Denver, Colorado, 80218

  • St. Joseph Hospital

    Denver, Colorado, 80218

  • Rose Medical Center

    Denver, Colorado, 80220

  • CCOP - Colorado Cancer Research Program, Incorporated

    Denver, Colorado, 80224-2522

  • Parkland Oncology-Hematology Clinic at Parkland Medical Center

    Derry, New Hampshire, 03038

  • Mercy Capitol Hospital

    Des Moines, Iowa, 50307

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309

  • John Stoddard Cancer Center at Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at Mercy Cancer Center

    Des Moines, Iowa, 50314

  • Mercy Cancer Center at Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • John Stoddard Cancer Center at Iowa Lutheran Hospital

    Des Moines, Iowa, 50316-2301

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Seacoast Cancer Center at Wentworth-Douglass Hospital

    Dover, New Hampshire, 03820

  • Delaware County Regional Cancer Center at Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • Oncology Hematology Associates of Northern Pennsylvania, P.C. at Hahne Regional Cancer Center

    DuBois, Pennsylvania, 15801

  • Wendt Regional Cancer Center at Finley Hospital

    Dubuque, Iowa, 52001

  • Cancer Care Center at St. Luke's Hospital

    Duluth, Minnesota, 55805

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Miller-Dwan Medical Center

    Duluth, Minnesota, 55805

  • St. Mary's - Duluth Clinic Cancer Center

    Duluth, Minnesota, 55805

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Dale and Frances Hughes Cancer Center at Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

  • Shore Regional Cancer Center at Memorial Hospital - Easton

    Easton, Maryland, 21601

  • Easton Regional Cancer Center at Easton Hospital

    Easton, Pennsylvania, 18042

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Cancer Center of Kansas, P.A. - El Dorado

    El Dorado, Kansas, 67042

  • Sherman Hospital

    Elgin, Illinois, 60120

  • Alexian Brothers Radiation Oncology

    Elk Grove Village, Illinois, 60007

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Union Hospital Cancer Center at Union Hospital

    Elkton, Maryland, 21921

  • Elmhurst Memorial Hospital

    Elmhurst, Illinois, 60126

  • Falck Cancer Center at Arnot Ogden Medical Center

    Elmira, New York, 14905

  • Swedish Medical Center

    Englewood, Colorado, 80110

  • Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • Ephrata Cancer Center at Ephrata Community Hospital

    Ephrata, Pennsylvania, 17522

  • Regional Cancer Center - Erie

    Erie, Pennsylvania, 16505

  • Green Bay Oncology, Limited - Escanaba

    Escanaba, Michigan, 49431

  • Eureka Community Hospital

    Eureka, Illinois, 61530

  • Evanston Northwestern Health Care - Evanston Hospital

    Evanston, Illinois, 60201-1781

  • Exeter Hospital Center for Cancer Care

    Exeter, New Hampshire, 03833

  • 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

  • Dakota Cancer Institute at Innovis Health - Dakota Clinic

    Fargo, North Dakota, 58103

  • CCOP - MeritCare Hospital

    Fargo, North Dakota, 58122

  • MeritCare Medical Group

    Fargo, North Dakota, 58122

  • Cape Fear Valley Medical Center

    Fayetteville, North Carolina, 28304

  • St. Francis Hospital

    Federal Way, Washington, 98003

  • Blanchard Valley Medical Associates

    Findlay, Ohio, 45840

  • Hunterdon Regional Cancer Center at Hunterdon Medical Center

    Flemington, New Jersey, 08822

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Great Lakes Cancer Institute at McLaren Regional Medical Center

    Flint, Michigan, 48532

  • McLeod Regional Medical Center

    Florence, South Carolina, 29501

  • Central Wisconsin Cancer Program at Agnesian HealthCare

    Fond du Lac, Wisconsin, 54935

  • Front Range Cancer Specialists

    Fort Collins, Colorado, 80524

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Broward General Medical Center Cancer Center

    Fort Lauderdale, Florida, 33316

  • MetroWest Medical Center - Framingham Union Hospital

    Framingham, Massachusetts, 01702

  • Frederick Memorial Hospital Regional Cancer Therapy Center

    Frederick, Maryland, 21701

  • Kaiser Permanente - Fremont

    Fremont, California, 94538

  • Washington Township Hospital

    Fremont, California, 94538

  • Fremont Memorial Hospital

    Fremont, Ohio, 43420

  • California Cancer Center - Woodward Park Office

    Fresno, California, 93720

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • Virginia K. Crosson Cancer Center at St. Jude Medical Center

    Fullerton, California, 92835

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610-0232

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Galesburg Clinic

    Galesburg, Illinois, 61401

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • InterCommunity Cancer Center of Western Illinois

    Galesburg, Illinois, 61401

  • Medical and Surgical Specialists, L L C

    Galesburg, Illinois, 61401

  • Delnor Community Hospital - Geneva

    Geneva, Illinois, 60134

  • Banner Thunderbird Medical Center

    Glendale, Arizona, 85306

  • Glendale Memorial Hospital Comprehensive Cancer Center

    Glendale, California, 91204

  • Oncology Alliance, SC - Milwaukee - East

    Glendale, Wisconsin, 53212-1038

  • Charles R. Wood Cancer Center at Glens Falls Hospital

    Glens Falls, New York, 12801

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Center for Cancer Care at Goshen Health System

    Goshen, Indiana, 46527

  • Altru Cancer Center at Altru Hospital

    Grand Forks, North Dakota, 58201

  • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

    Grand Junction, Colorado, 81502

  • 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

  • Metropolitan Hospital

    Grand Rapids, Michigan, 49506

  • Big Sky Oncology

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Sletten Regional Cancer Institute

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • 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

  • Marin Cancer Institute at Marin General Hospital

    Greenbrae, California, 94904

  • Sutter Health - Western Division Cancer Research Group

    Greenbrae, California, 94904

  • Franklin Medical Center

    Greenfield, Massachusetts, 01301

  • Moses Cone Regional Cancer Center at Wesley Long Community Hospital

    Greensboro, North Carolina, 27403-1199

  • 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

  • CCOP - Northern New Jersey

    Hackensack, New Jersey, 07601

  • Cancer Institute of New Jersey at Hamilton

    Hamilton, New Jersey, 08690

  • Virginia Oncology Associates - Hampton

    Hampton, Virginia, 23666

  • PinnacleHealth Regional Cancer Center at Polyclinic Hospital

    Harrisburg, Pennsylvania, 17105

  • Helen and Harry Gray Cancer Center at Hartford Hospital

    Hartford, Connecticut, 06102-5037

  • Ingalls Cancer Care Center at Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Hattiesburg Clinic, P.A.

    Hattiesburg, Mississippi, 39401

  • Mason District Hospital

    Havana, Illinois, 62644

  • Kaiser Permanente Medical Center - Hayward

    Hayward, California, 94545

  • Saint Rose Hospital

    Hayward, California, 94545

  • Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Penn State Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • High Point Regional Hospital

    High Point, North Carolina, 27261

  • Hinsdale Hematology Oncology Associates

    Hinsdale, Illinois, 60521

  • Holland Community Hospital

    Holland, Michigan, 49423

  • Memorial Cancer Institute at Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • New Hampshire Oncology-Hematology, PA - Hooksett

    Hooksett, New Hampshire, 03106

  • Hopedale Medical Complex

    Hopedale, Illinois, 61747

  • Saint Joseph's Mercy Cancer Center

    Hot Springs, Arkansas, 71913

  • Terrebonne General Medical Center

    Houma, Louisiana, 70360

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

    Houston, Texas, 77030-4009

  • Baylor University Medical Center - Houston

    Houston, Texas, 77030

  • New York Oncology Hematology, P.C. at Cavell Cancer Treatment Program

    Hudson, New York, 12534

  • Marshall University Medical Center

    Huntington, West Virginia, 25701

  • St. Mary's Regional Cancer Center at St. Mary's Medical Center

    Huntington, West Virginia, 25702

  • Huntsville Hospital

    Huntsville, Alabama, 35801

Other trials in United States

Canada13 sites

  • Cross Cancer Institute at University of Alberta

    Edmonton, Alberta, T6G 1Z2

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V8

  • Hopital Notre-Dame du CHUM

    Montreal, Quebec, H2L 4M1

  • Hotel Dieu de Montreal

    Montreal, Quebec, H2W 1T8

  • CHUM Hopital Saint-Luc

    Montreal, Quebec, H2X 3J4

  • Royal Victoria Hospital - Montreal

    Montreal, Quebec, H3A 1A1

  • Montreal General Hospital

    Montreal, Quebec, H3G 1A4

  • Ottawa Hospital Regional Cancer Centre - General Campus

    Ottawa, Ontario, K1Y 4K7

  • Hopital du Saint-Sacrement, Quebec

    Québec, Quebec, G1S 4L8

  • Allan Blair Cancer Centre at Pasqua Hospital

    Regina, Saskatchewan, S4T 7T1

  • Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • Women's College Ambulatory Care Center at Sunnybrook and Women's College Health Science Center

    Toronto, Ontario, M5S 1B2

Other trials in Canada

Puerto Rico3 sites

  • Andres Grillasca Hospital

    Ponce, 00733

  • Hato Rey Hematology/Oncology Group

    San Juan, 00917

  • San Juan City Hospital

    San Juan, 00928

Other trials in Puerto Rico

About this study

Official title: A Clinical Trial Comparing Anastrozole With Tamoxifen in Postmenopausal Patients With Ductal Carcinoma in Situ (DCIS) Undergoing Lumpectomy With Radiation Therapy

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Tamoxifen may fight breast cancer by blocking the use of estrogen. Anastrozole may fight breast cancer by decreasing estrogen production. It is not yet known whether anastrozole is more effective than tamoxifen in preventing the recurrence of breast cancer.

PURPOSE: This randomized phase III trial is studying anastrozole to see how well it works compared to tamoxifen in preventing the recurrence of breast cancer in postmenopausal women with ductal carcinoma in situ who are undergoing lumpectomy and radiation therapy.

Read the detailed description

OBJECTIVES:

  • Compare the value of anastrozole vs tamoxifen, in terms of preventing recurrence (i.e., local, regional, and distant recurrences and contralateral breast cancer), after lumpectomy and radiotherapy in postmenopausal women with ductal carcinoma in situ (DCIS).
  • Compare subsequent disease occurrence, in terms of invasive breast cancer (local, regional, distant, or contralateral), ipsilateral and contralateral breast cancer (invasive and DCIS), and non-breast second primary malignancies, in patients treated with these drugs.
  • Compare quality of life and symptoms of patients treated with these drugs.*
  • Compare quality-adjusted survival time of patients treated with these drugs.*
  • Compare the occurrence of osteoporotic fractures in patients treated with these drugs.
  • Compare disease-free and overall survival of patients treated with these drugs. NOTE: *The quality of life study closed to accrual as of 12/28/04.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age (under 60 vs 60 and over). Patients are randomized to 1 of 2 treatment arms (arm I and arm II closed to accrual as of 6/15/06).

  • Arm I (closed to accrual as of 6/15/06): Patients receive oral tamoxifen and oral placebo once daily for 5 years.
  • Arm II (closed to accrual as of 6/15/06): Patients receive oral anastrozole and oral placebo once daily for 5 years.

Beginning within 8 weeks of randomization, all patients also undergo whole breast radiotherapy, unless the patient is enrolled in protocol NSABP-B-39 and randomized to the partial breast irradiation group.

Patients are followed every 6 months for 5 years, and then annually thereafter.

For patients enrolled in the quality of life study, quality of life is assessed at baseline and then every 6 months for 6 years.*

NOTE: *The quality of life study closed to accrual as of 12/28/04.

PROJECTED ACCRUAL: A total of 3,000 patients (1,500 per treatment arm) will be accrued for this study within 5 years (arm I and arm II closed to accrual as of 6/15/06).

Conditions
Breast Cancer
Being tested
anastrozole, tamoxifen citrate, 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.

  • anastrozoleDrug

    1 mg/day and placebo for 5 years

  • tamoxifen citrateDrug

    20 mg/day and placebo for 5 years

  • Radiation TherapyRadiation

    Adjuvant radiation therapy

Study groups in NCT00053898
Study groupRoleWhat they receive
Group 1Active comparatortamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years
Receives: Drug: tamoxifen citrate; Radiation: Radiation Therapy
Group 2Experimentalanastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years
Receives: Drug: anastrozole; Radiation: Radiation Therapy

What is being measured

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

  1. Percentage of Patients Free From Breast Cancer

    Percentage of patients free from breast cancer event at 10 years where events include local, regional, or distant recurrence or contralateral breast cancer, invasive or DCIS.

    Measured: 10 years

Secondary outcomes (9)

  1. Percentage of Patients Free From Invasive Breast Cancer

    Percentage of patients free from an invasive breast cancer event where events include invasive local, regional, or distant recurrence, or contralateral breast cancer, occurring as a first cancer event. Note that this endpoint includes only invasive breast cancers and the primary endpoint includes both invasive and DCIS breast cancers.

    Measured: 10 years

  2. Percentage of Patients Free From Ipsilateral Recurrence

    Percentage of patients free from a breast cancer recurrence in the ipsilateral breast (invasive and DCIS), occurring as a first cancer event.

    Measured: 10 years

  3. Percentage of Patients Free From Contralateral Breast Cancer

    Percentage of patients free from a breast cancer recurrence in the contralateral breast (invasive and DCIS), occurring as a first cancer event.

    Measured: 10 years

  4. Percentage of Patients Free From Non-breast Secondary Cancer

    Percentage of patients free from any non-breast second primary cancer other than squamous or basal cell carcinoma of the skin, carcinoma in situ of the colon, melanoma in situ, or carcinoma in situ of the cervix, occurring as a first cancer event.

    Measured: 10 years

  5. Percentage of Patients Free From Osteoporotic Fractures

    Percentage of patients free from fractures of the hip, spine, and wrist.

    Measured: 10 years

  6. Percentage of Patients Alive and Disease-free

    Percentage of patients free from a disease-free survival event where events include any recurrence, second primary cancer, and death from any cause. Lobular carcinoma in situ (LCIS), basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the colon, melanoma in situ, and cervical carcinoma in situ will not be included as recurrences or second primary cancer.

    Measured: 10 years

  7. Percentage of Patients Alive (Overall Survival)

    Percentage of patients alive.

    Measured: 10 years

  8. Quality of Life-Short Form 12 (SF-12) Physical Health Component Score

    The primary outcome of the QOL substudy was the Medical Outcomes Study-Short Form 12 (SF-12) physical health component scale score. The SF-12 physical score was calculated to have a range of 0-100 and was normalized to have a mean of 50 and a standard deviation of 10 in the general population. Higher scores indicate better health.

    Measured: 5 years

  9. Quality-adjusted Survival Time

    The mean quality-adjusted survival time (in months) in each treatment group, estimated by the Quality-Adjusted Time without Symptoms and Toxicity (Q-TWIST) method.

    Measured: 10 years

Timeline

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

  1. First posted6 Feb 2003 (estimated)
  2. Study startJan 2003
  3. Primary completionMar 2015
  4. Study completionMay 2016

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3,104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00053898
Sponsor's protocol ID
NSABP B-35
Other IDs
NSABP-B-35, SWOG-NSABP-B-35, NCCTG-NSABP-B-35, ACOSOG-NSABP-B-35
Status last verified
Sep 2018
First submitted
5 Feb 2003
Last updated
20 Sep 2018
Data monitoring committee
Yes

Publications

  • Land SR, Ritter MW, Costantino JP, Julian TB, Cronin WM, Haile SR, Wolmark N, Ganz PA. Compliance with patient-reported outcomes in multicenter clinical trials: methodologic and practical approaches. J Clin Oncol. 2007 Nov 10;25(32):5113-20. doi: 10.1200/JCO.2007.12.1749.

    PubMed 17991930

  • Margolese RG, Cecchini RS, Julian TB, Ganz PA, Costantino JP, Vallow LA, Albain KS, Whitworth PW, Cianfrocca ME, Brufsky AM, Gross HM, Soori GS, Hopkins JO, Fehrenbacher L, Sturtz K, Wozniak TF, Seay TE, Mamounas EP, Wolmark N. Anastrozole versus tamoxifen in postmenopausal women with ductal carcinoma in situ undergoing lumpectomy plus radiotherapy (NSABP B-35): a randomised, double-blind, phase 3 clinical trial. Lancet. 2016 Feb 27;387(10021):849-56. doi: 10.1016/S0140-6736(15)01168-X. Epub 2015 Dec 11.

    PubMed 26686957

  • Ganz PA, Cecchini RS, Julian TB, Margolese RG, Costantino JP, Vallow LA, Albain KS, Whitworth PW, Cianfrocca ME, Brufsky AM, Gross HM, Soori GS, Hopkins JO, Fehrenbacher L, Sturtz K, Wozniak TF, Seay TE, Mamounas EP, Wolmark N. Patient-reported outcomes with anastrozole versus tamoxifen for postmenopausal patients with ductal carcinoma in situ treated with lumpectomy plus radiotherapy (NSABP B-35): a randomised, double-blind, phase 3 clinical trial. Lancet. 2016 Feb 27;387(10021):857-65. doi: 10.1016/S0140-6736(15)01169-1. Epub 2015 Dec 11.

    PubMed 26686960

  • Wapnir IL, Cecchini RS, Dignam JJ, Anderson SJ, Li J, Suga JM, Brufsky AM, Hopkins JO, Zeitzer K, Lyons JA, Conlin AK, Kuerer HM, Siddique S, Vallow LA, Albain KS, Cianfrocca ME, Julian TB, Boileau JF, Mamounas EP, Wolmark N. Lumpectomy Margins and Local Recurrence in DCIS: Results From the NRG Oncology/NSABP B-35 Randomized Clinical Trial. JAMA Surg. 2026 Jul 1:e262340. doi: 10.1001/jamasurg.2026.2340. Online ahead of print.

    PubMed 42384406

  • Duggal S, Robin J, Julian TB. Ductal carcinoma in situ: an overview. Expert Rev Anticancer Ther. 2013 Aug;13(8):955-62. doi: 10.1586/14737140.2013.820557.

    PubMed 23984897

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing anastrozole, tamoxifen citrate and Radiation Therapy in people with Breast Cancer, run by NSABP Foundation Inc at 740 sites in 3 countries.

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

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 740 sites in United States, Canada, Puerto Rico. 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?

Yes. Results are posted in the registry (first posted 12 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Patients Free From Breast Cancer (time frame: 10 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 NCT00053898, which also lists 5 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 20 Sep 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in