AzTrials
AzTrials

Breast CancerPhase 3NCT00382070

Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer

A Phase 3 study testing Letrozole in people with Breast Cancer, run by NSABP Foundation Inc at 806 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether letrozole is more effective than a placebo in treating patients with hormone receptor-positive breast cancer. Read more about this study

Who is it for?
Ages 18 to 120 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Letrozole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,966 participants
Where
806 sitesin 3 countries
Study dates
Aug 2006to Apr 2025
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 18 to 120 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Eligibility Criteria

  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (0 = fully active, able to carry on all pre-disease performance without restriction; 1 = restricted in physically strenuous activity but ambulatory).
  • Patients must be postmenopausal at the time of randomization. (Note: Premenopausal or perimenopausal women requiring therapy with luteinizing hormone-releasing hormone [LHRH] analogs to suppress ovarian function are not eligible.) For study purposes, postmenopausal is defined as: age 56 or older with no spontaneous menses for at least 12 months prior to study entry, or age 55 or younger with no spontaneous menses for at least 12 months prior to study entry (e.g., spontaneous or secondary to hysterectomy) AND with a documented estradiol level in the postmenopausal range according to local institutional/laboratory standards, or a prior documented bilateral oophorectomy.
  • The patient must have remained disease-free from the time of initial breast cancer diagnosis until the time of randomization.
  • The patient must have had histologically-confirmed invasive carcinoma of the breast by diagnostic core needle biopsy or by final pathologic evaluation of the surgical specimen.
  • Patients who received neoadjuvant chemotherapy must have been clinical Stage I, II, or IIIA. For patients who received adjuvant chemotherapy, the primary tumor must have been T1-3 on pathologic evaluation and ipsilateral nodes must have been pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN3a, or pN3b.
  • The primary tumor must have been estrogen receptor (ER)-positive and/or progesterone receptor (PgR)-positive. (Patients who had a tumor that was considered to be borderline for hormone receptor positivity and who were treated with tamoxifen and/or an aromatases inhibitor (AI) are eligible for this study.)
  • Patients must have undergone either a lumpectomy with axillary nodal staging followed by breast radiotherapy or a total mastectomy with axillary nodal staging. (Acceptable axillary nodal staging procedures include sentinel node biopsy alone, if sentinel nodes were negative on hematoxylin and eosin (H\&E) staining.)
  • The duration of the patient's hormonal therapy following breast cancer diagnosis must have been 57-63 months from the first dose regardless of the number of missed doses. Hormonal therapy must have consisted of an AI or a combination of up to 3 years of tamoxifen followed by an AI. Tamoxifen may not have been given during years 4 and 5 of the 5 years of adjuvant hormonal therapy. (Note: Patients must discontinue their adjuvant AI therapy at the time of randomization.)
  • Optional Letrozole Registration Program for patients who have not yet completed 5 years of hormonal therapy. (Note: As of September 5, 2008, the optional NSABP B-42 Registration Program closed to patient enrollment. Accrual and data collection for the NSABP B-42 randomized treatment trial continues as planned.) In order to have a predominantly letrozole-treated population for B-42 study entry, patients who have had a minimum of 2 years of hormonal therapy and who are currently on tamoxifen (for up to 3 years) or an AI may be offered letrozole at no cost until they complete 5 total years of initial adjuvant hormonal therapy.
  • B-42 randomization must be within 6 months following completion of 5 years (57-63 months) of initial adjuvant hormonal therapy.
  • At the time of randomization, the patient must have had the following: history and physical exam within 3 months demonstrating no findings suggestive of recurrent breast cancer; bilateral mammogram within 1 year (unilateral if patient had a mastectomy); mammogram not required if patient had a prophylactic contralateral mastectomy; bone mineral density (BMD) testing within 1 year; and fasting lipid profile (total cholesterol, LDL-C, HDL-C, and triglycerides) with a total cholesterol value less than or equal to grade 1 (according to CTCAE v3.0), with or without cholesterol-lowering therapy.
  • within 1 year if the patient has a history of hypercholesterolemia controlled with cholesterol-lowering therapy and/or therapeutic lifestyle changes or if the patient has a history of one or more of the following risk factors for future cardiovascular events: diabetes, hypertension, obesity, tobacco use, hypertriglyceridemia, documented coronary artery disease, or family history of premature coronary heart disease.
  • within 2 years for all other patients.

Ineligibility Criteria

  • Patients with one or more of the following conditions will be ineligible for this study:
  • History of non-traumatic osteoporotic fracture of wrist, hip, or spine.
  • Diagnosis of bilateral breast cancer including ductal carcinoma in situ (DCIS)[(synchronous or metachronous].
  • Other malignancies unless the patient is considered to be disease-free for 5 or more years prior to randomization, and is deemed by their physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, colon carcinoma in situ, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
  • Sex hormonal therapy, e.g., estrogen- or progesterone-replacement therapy or oral contraceptives. These patients are eligible only if this therapy is discontinued prior to randomization.
  • Therapy with any hormonal agent such as raloxifene for management of osteoporosis. Patients are eligible only if these medications are discontinued prior to study entry.
  • Administration of any investigational agent within 30 days before study entry.

Trial locations and contacts

806 sites in 3 countries.

329 sites in 3 countries

United States300 sites

  • Kapiolani Medical Center at Pali Momi

    ‘Aiea, Hawaii, 96701

  • Hickman Cancer Center at Bixby Medical Center

    Adrian, Michigan, 49221

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44307

  • Summa Center for Cancer Care at Akron City Hospital

    Akron, Ohio, 44309-2090

  • Phoebe Cancer Center at Phoebe Putney Memorial Hospital

    Albany, Georgia, 31701

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

    Albany, New York, 12206

  • New York Oncology Hematology, PC at Albany Medical Center

    Albany, New York, 12208

  • Lovelace Medical Center - Downtown

    Albuquerque, New Mexico, 87102

  • Hematology Oncology Associates, PC

    Albuquerque, New Mexico, 87106

  • New Mexico Cancer Center

    Albuquerque, New Mexico, 87109

  • University of New Mexico Cancer 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

  • American Fork Hospital

    American Fork, Utah, 84003

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • Amsterdam Community Cancer Program

    Amsterdam, New York, 12010

  • Providence Cancer Center

    Anchorage, Alaska, 99508

  • AnMed Cancer Center

    Anderson, South Carolina, 29621

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • Regional Medical Center

    Anniston, Alabama, 36202

  • Hospital District Sixth of Harper County

    Anthony, Kansas, 67003

  • Randolph Hospital

    Asheboro, North Carolina, 27203-5400

  • 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, 41101-0151

  • Cancer Care at Our Lady of Bellefonte Hospital

    Ashland, Kentucky, 41101

  • Northeast Georgia Cancer Care, LLC - Medical Oncology

    Athens, Georgia, 30607

  • Georgia Cancer Center for Excellence at Grady Memorial Hospital

    Atlanta, Georgia, 30303

  • 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

  • University of Colorado Cancer Center at UC Health Sciences Center

    Aurora, Colorado, 80045

  • WellStar Cobb Hospital

    Austell, Georgia, 30106

  • Southwest Regional Cancer Center - Central

    Austin, Texas, 78705

  • Texas Oncology, PA at Texas Oncology Cancer Center - Central

    Austin, Texas, 78731

  • Texas Oncology, PA - Austin Northwest

    Austin, Texas, 78759

  • Texas Oncology, PA - Austin North

    Austin, Texas, 78759

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Greater Baltimore Medical Center Cancer Center

    Baltimore, Maryland, 21204

  • St. Agnes Hospital Cancer Center

    Baltimore, Maryland, 21229

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

    Baltimore, Maryland, 21237

  • CancerCare of Maine at Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Barberton Citizens Hospital

    Barberton, Ohio, 44203

  • Pennington Cancer Center at Baton Rouge General

    Baton Rouge, Louisiana, 70806

  • Mary Bird Perkins Cancer Center - Baton Rouge

    Baton Rouge, Louisiana, 70809

  • Ochsner Health Center - Bluebonnet

    Baton Rouge, Louisiana, 70809

  • Battle Creek Health System Cancer Care Center

    Battle Creek, Michigan, 49017

  • Bay Regional Medical Center

    Bay City, Michigan, 48708

  • Cleveland Clinic Beachwood Family Health and Surgery Center

    Beachwood, Ohio, 44122

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

    Beech Grove, Indiana, 46107

  • Mary Rutan Hospital

    Bellefontaine, Ohio, 43311

  • Overlake Cancer Center at Overlake Hospital Medical Center

    Bellevue, Washington, 98004

  • St. Joseph Cancer Center

    Bellingham, Washington, 98225

  • MeritCare Bemidji

    Bemidji, Minnesota, 56601

  • St. Charles Medical Center - Bend

    Bend, Oregon, 97701

  • Alta Bates Summit Comprehensive Cancer Center

    Berkeley, California, 94704

  • Mountainview Medical

    Berlin Corners, Vermont, 05602

  • Suburban Hospital

    Bethesda, Maryland, 20814

  • St. Luke's Cancer Network at St. Luke's Hospital

    Bethlehem, Pennsylvania, 18015

  • Hematology Oncology Associates of the Quad Cities

    Bettendorf, Iowa, 52722

  • Study site

    Bettendorf, Iowa, 52722

  • Mecosta County Medical Center

    Big Rapids, Michigan, 49307

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana, 59101

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Bismarck Cancer Center

    Bismarck, North Dakota, 58501

  • Medcenter One Hospital Cancer Care Center

    Bismarck, North Dakota, 58501

  • Mid Dakota Clinic, PC

    Bismarck, North Dakota, 58501

  • St. Alexius Medical Center Cancer Center

    Bismarck, North Dakota, 58502

  • St. Joseph Medical Center

    Bloomington, Illinois, 61701

  • Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - West

    Boca Raton, Florida, 33428

  • Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus

    Boca Raton, Florida, 33486

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

    Boise, Idaho, 83706

  • Mountain States Tumor Institute at St. Luke's Regional Medical Center

    Boise, Idaho, 83712

  • Tufts-NEMC Cancer Center

    Boston, Massachusetts, 02111

  • Boston University Cancer Research Center

    Boston, Massachusetts, 02118

  • Boulder Community Hospital

    Boulder, Colorado, 80301-9019

  • Wood County Oncology Center

    Bowling Green, Ohio, 43402

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • Ocean Medical Center at Meridian Health

    Brick, New Jersey, 08724

  • Bridgeport Hospital

    Bridgeport, Connecticut, 06610

  • Bristol Hospital

    Bristol, Connecticut, 06011-0977

  • Coney Island Hospital

    Brooklyn, New York, 11235

  • St. Joseph Regional Cancer Center

    Bryan, Texas, 77802

  • 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

  • Peninsula Medical Center

    Burlingame, California, 94010

  • Lahey Clinic Medical Center - Burlington

    Burlington, Massachusetts, 01805

  • Alamance Cancer Center at Alamance Regional Medical Center

    Burlington, North Carolina, 27216

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont, 05401

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • St. James Healthcare Cancer Care

    Butte, Montana, 59701

  • Graham Hospital

    Canton, Illinois, 61520

  • Mercy Cancer Center at Mercy Medical Center

    Canton, Ohio, 44708

  • Aultman Cancer Center at Aultman Hospital

    Canton, Ohio, 44710-1799

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Waverly Hematology Oncology

    Cary, North Carolina, 27511

  • East Bay Radiation Oncology Center

    Castro Valley, California, 94546

  • Eden Medical Center

    Castro Valley, California, 94546

  • Valley Medical Oncology Consultants - Castro Valley

    Castro Valley, California, 94546

  • Sandra L. Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Texas Oncology, PA - Cedar Park

    Cedar Park, Texas, 78613

  • 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

    Centralia, Washington, 98531-9027

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • 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 Health Sciences Center - Charleston

    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

  • Saint Luke's Hospital

    Chesterfield, Missouri, 63017

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Resurrection Medical Center

    Chicago, Illinois, 60631

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Louis A. Weiss Memorial Hospital

    Chicago, Illinois, 60640

  • Creticos Cancer Center at Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Marshfield Clinic - Chippewa Center

    Chippewa Falls, Wisconsin, 54729

  • Christ Hospital Cancer Center

    Cincinnati, Ohio, 45219

  • Oncology Hematology Care, Incorporated - Blue Ash

    Cincinnati, Ohio, 45242

  • United Hospital Center

    Clarksburg, West Virginia, 26301

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106-5065

  • MetroHealth Cancer Care Center at MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Cleveland Clinic Cancer Center at Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • North Coast Cancer Care - Clyde

    Clyde, Ohio, 43410

  • Kootenai Cancer Center - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

  • Memorial Hospital Cancer Center - Colorado Springs

    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 Cancer Center

    Columbus, Georgia, 31904

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

    Columbus, Ohio, 43210-1240

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214-3998

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Grant Medical Center Cancer Care

    Columbus, Ohio, 43215

  • Mount Carmel Health - West Hospital

    Columbus, Ohio, 43222

  • Doctors Hospital at Ohio Health

    Columbus, Ohio, 43228

  • Cancer Care Center at John Muir Health - Concord Campus

    Concord, California, 94524-4110

  • Commonwealth Hematology-Oncology, PC - Concord

    Concord, Massachusetts, 01742

  • New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care

    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

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

  • Heartland Oncology and Hematology

    Council Bluffs, Iowa, 51503

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Presbyterian Hospital of Dallas

    Dallas, Texas, 75231

  • Praxair Cancer Center at Danbury Hospital

    Danbury, Connecticut, 06810

  • Geisinger Cancer Institute at Geisinger Health

    Danville, Pennsylvania, 17822-0001

  • Mercy Fitzgerald Hospital

    Darby, Pennsylvania, 19023

  • Genesis Regional Cancer Center at Genesis Medical Center

    Davenport, Iowa, 52803

  • Genesis Medical Center - West Campus

    Davenport, Iowa, 52804

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital

    Dayton, Ohio, 45406

  • David L. Rike Cancer Center at Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Cancer Care Center

    Dayton, Ohio, 45415

  • CCOP - Dayton

    Dayton, Ohio, 45420

  • Herbert D. Kerman Regional Oncology Center - Daytona Beach

    Daytona Beach, Florida, 32114

  • 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

  • North Broward Medical Center

    Deerfield Beach, Florida, 33064-3596

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Denver Health Medical Center

    Denver, Colorado, 80204

  • St. Anthony Central Hospital

    Denver, Colorado, 80204

  • 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

  • Veterans Affairs Medical Center - Denver

    Denver, Colorado, 80220

  • CCOP - Colorado Cancer Research Program

    Denver, Colorado, 80224-2522

  • 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 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

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Commonwealth Hematology Oncology PC - Dorchester

    Dorchester, Massachusetts, 02124

  • Seacoast Cancer Center at Wentworth - Douglass Hospital

    Dover, New Hampshire, 03820

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center

    DuBois, Pennsylvania, 15801

  • Duluth Clinic Cancer Center - Duluth

    Duluth, Minnesota, 55805-1983

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Miller - Dwan Medical Center

    Duluth, Minnesota, 55805

  • St. Luke's Hospital Cancer Care Center

    Duluth, Minnesota, 55805

  • Dale and Frances Hughes Cancer Center at Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

  • CCOP - Hematology-Oncology Associates of Central New York

    East Syracuse, New York, 13057

  • Shore Regional Cancer Center at Memorial Hospital - Easton

    Easton, Maryland, 21601

  • Marshfield Clinic Cancer Care at Regional Cancer Center

    Eau Claire, Wisconsin, 54701

  • Luther Midlelfort Hospital

    Eau Claire, Wisconsin, 54702

  • Midelfort Clinic - Luther

    Eau Claire, Wisconsin, 54703-1510

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Shaw Regional Cancer Center

    Edwards, Colorado, 81632

  • Cancer Center of Kansas, PA - 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

  • Vince Lombardi Cancer Center at Aurora Lakeland Medical Center - Elkhorn

    Elkhorn, Wisconsin, 53121

  • Union Hospital Cancer Program at Union Hospital

    Elkton, Maryland, 21921

  • Elmhurst Memorial Hospital

    Elmhurst, Illinois, 60126

  • Hematology Oncology Center

    Elyria, Ohio, 44035

  • Swedish Medical Center

    Englewood, Colorado, 80110

  • Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • Green Bay Oncology, Limited - Escanaba

    Escanaba, Michigan, 49431

  • Eureka Community Hospital

    Eureka, Illinois, 61530

  • Evanston Hospital

    Evanston, Illinois, 60201-1781

  • Center for Cancer Care at Exeter Hospital

    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

    Fall River, Massachusetts, 02721

  • Dakota Cancer Institute at Dakota Clinic - South University

    Fargo, North Dakota, 58103

  • CCOP - MeritCare Hospital

    Fargo, North Dakota, 58122

  • MeritCare Broadway

    Fargo, North Dakota, 58122

  • Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center

    Farmington, Connecticut, 06360-2875

  • St. Francis Hospital

    Federal Way, Washington, 98003

  • Blanchard Valley Medical Associates

    Findlay, Ohio, 45840

  • Simonds-Sinon Regional Cancer Center at HealthAlliance Hospital - Burbank Campus

    Fitchburg, Massachusetts, 01420

  • 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

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Front Range Cancer Specialists

    Fort Collins, Colorado, 80528

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

    Fort Lauderdale, Florida, 33308

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Frederick Memorial Hospital Regional Cancer Therapy Center

    Frederick, Maryland, 21701

  • Fredericksburg Oncology, Incorporated

    Fredericksburg, Virginia, 22401

  • CentraState Medical Center

    Freehold, New Jersey, 07728

  • Kaiser Permanente - Fremont

    Fremont, California, 94538

  • Valley Medical Oncology

    Fremont, California, 94538

  • Cancer Care Associates

    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, PC

    Galesburg, Illinois, 61401

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • CaroMont Cancer Center at Gaston Memorial Hospital

    Gastonia, North Carolina, 28053

  • Georgetown Memorial Hospital

    Georgetown, South Carolina, 29440

  • Glendale Memorial Hospital Comprehensive Cancer Center

    Glendale, California, 91204

  • Oncology Alliance, SC - Milwaukee - East

    Glendale, Wisconsin, 53212-1038

  • Adirondack Cancer Care - Glens Falls

    Glens Falls, New York, 12801

  • Charles R. Wood Cancer Center at Glens Falls Hospital

    Glens Falls, New York, 12801

  • Addison Gilbert Hospital

    Gloucester, Massachusetts, 01930

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Center for Cancer Care at Goshen General Hospital

    Goshen, Indiana, 46526

  • Altru Cancer Center at Altru Hospital

    Grand Forks, North Dakota, 58201

  • Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center

    Grand Island, Nebraska, 68803

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

    Grand Junction, Colorado, 81502

  • Butterworth Hospital at Spectrum Health

    Grand Rapids, Michigan, 49503

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • Three Rivers Community Hospital

    Grants Pass, Oregon, 97527

  • Big Sky Oncology

    Great Falls, Montana, 59405-5309

  • Sletten Cancer Institute at Benefis Healthcare

    Great Falls, Montana, 59405

  • Study site

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center

    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

  • Moses Cone Regional Cancer Center at Wesley Long Community Hospital

    Greensboro, North Carolina, 27403-1198

  • Leo W. Jenkins Cancer Center at ECU Medical School

    Greenville, North Carolina, 27834

  • Wayne Hospital

    Greenville, Ohio, 45331

  • 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

  • Cancer Institute of New Jersey at Hamilton

    Hamilton, New Jersey, 08690

  • Helen and Harry Gray Cancer Center at Hartford Hospital

    Hartford, Connecticut, 06102-5037

  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Hattiesburg Clinic, PA at Forrest General

    Hattiesburg, Mississippi, 39401

  • Mason District Hospital

    Havana, Illinois, 62644

  • Northern Montana Hospital

    Havre, Montana, 59501

  • Kaiser Permanente Medical Center - Hayward

    Hayward, California, 94545

  • Geisinger Hazleton Cancer Center

    Hazleton, Pennsylvania, 18201

Other trials in United States

Canada18 sites

  • Northeastern Ontario Regional Cancer Centre

    Greater Sudbury, Ontario, P3E 5J1

  • 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

  • Carlo Fidani Peel Regional Cancer Centre at Credit Valley Hospital

    Mississauga, Ontario, L5M 2N1

  • Hopital Notre-Dame du CHUM

    Montreal, Quebec, H2L 4M1

  • CHUM - Hotel Dieu Hospital

    Montreal, Quebec, H2W 1T8

  • CHUM - Hopital Saint-Luc

    Montreal, Quebec, H2X 3J4

  • Royal Victoria Hospital - Montreal

    Montreal, Quebec, H3A 1A1

  • Jewish General Hospital - Montreal

    Montreal, Quebec, H3T 1E2

  • St. Mary's Hospital Center

    Montreal, Quebec, H3T 1M5

  • Hopital du Saint-Sacrement - Quebec

    Québec, Quebec, G1S 4L8

  • BCCA - Fraser Valley Cancer Centre

    Surrey, British Columbia, V3V 1Z2

  • Cancer Care Program at Thunder Bay Regional Health Sciences

    Thunder Bay, Ontario, P7B 6V4

  • Mount Sinai Hospital - Toronto

    Toronto, Ontario, M5G 1X5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • British Columbia Cancer Agency - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

  • British Columbia Cancer Agency - Vancouver Island Centre

    Victoria, British Columbia, V8R 6V5

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Ireland11 sites

  • Cork University Hospital

    Cork

  • South Infirmary Victoria Hospital

    Cork

  • Beaumont Hospital

    Dublin, 0009

  • Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital

    Dublin, 24

  • St. Vincent's University Hospital

    Dublin, 4

  • Mater Misericordiae University Hospital

    Dublin, 7

  • St. James's Hospital

    Dublin, 8

  • University College Hospital

    Galway, GY.

  • Mid-Western Cancer Centre at Mid-Western Regional Hospital

    Limerick, 0009

  • Sligo General Hospital

    Sligo, Sligo

  • Waterford Regional Hospital

    Waterford, 0009

Other trials in Ireland

About this study

Official title: A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an AI in Prolonging Disease-Free Survival in Postmenopausal Women With Hormone Receptor Positive Breast Cancer

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether letrozole is more effective than a placebo in treating patients with hormone receptor-positive breast cancer.

PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in treating postmenopausal women who have received hormone therapy for hormone receptor-positive breast cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine whether or not prolonged adjuvant hormonal therapy comprising letrozole vs placebo will improve disease-free survival of postmenopausal women with estrogen receptor-positive and/or progesterone receptor-positive breast cancer who have completed 5 years of hormonal therapy with 5 years of an aromatase inhibitor (AI) or 5 years of a combination of up to 3 years of tamoxifen citrate followed by an AI.
  • Compare the disease-free survival of patients treated with these regimens.

Secondary

  • Compare overall survival of patients treated with these regimens.
  • Compare breast cancer-free interval of patients treated with these regimens.
  • Compare distant recurrence in patients treated with these regimens.
  • Compare the incidence of osteoporotic-related fractures (e.g., Colles', hip, and spine) in these patients treated with these regimens.
  • Compare the incidence of arterial thrombotic events in patients treated with these regimens.

OUTLINE: This is a double-blind, multicenter, placebo-controlled, randomized study. Patients are stratified according to pathologic nodal status (negative vs positive), adjuvant tamoxifen citrate therapy (yes vs no), and lowest bone mineral density T score for lumbosacral spine, total hip, or femoral neck (> -2.0 vs ≤ -2.0 standard deviation). Patients are randomized to 1 of 2 treatment arms.

  • Group I: Patients receive oral placebo once daily.
  • Group II: Patients receive oral letrozole once daily.

In both arms, treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed annually.

PROJECTED ACCRUAL: A total of 3,840 patients will be accrued for this study.

Conditions
Breast Cancer
Being tested
Letrozole, Placebo
Keywords
stage I breast cancer, stage II breast cancer, stage IIIA breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

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

  • LetrozoleDrug

    Letrozole 2.5 mg taken orally once daily for 5 years

  • PlaceboOther

    Placebo tablet taken orally once daily for 5 years

Study groups in NCT00382070
Study groupRoleWhat they receive
Group 2 LetrozoleExperimentalPatients receive oral letrozole once daily for up to 5 years.
Receives: Drug: Letrozole
Group 1 PlaceboPlacebo comparatorPatients receive oral placebo once daily for up to 5 years.
Receives: Other: Placebo

What is being measured

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

  1. Disease-free Survival

    Percentage of patients free from DFS events. DFS events include local, regional, or distant recurrence, second primary cancer or death from any cause prior to recurrence or second primary cancer.

    Measured: 7 years.

Secondary outcomes (5)

  1. Overall Survival

    Percentage of patients alive

    Measured: 7 years

  2. Breast Cancer-free Interval

    Cumulative incidence of breast-cancer-free interval events. BCFI events include local-regional recurrence, distant recurrence or contralateral breast cancer as a first event.

    Measured: 7 years

  3. Distant Recurrence

    Cumulative incidence of distant recurrences.

    Measured: 7 years

  4. Osteoporotic-related Fractures

    Cumulative incidence of osteoporotic-related fractures defined as Colles', hip or spinal fractures

    Measured: 7 years

  5. Arterial Thrombotic Events

    Cumulative incidence of arterial thrombotic events, as defined by CTCAE version 4.0 (grade ≥1 stroke or transient ischaemic attack; grade ≥2 acute coronary syndrome or cerebrovascular ischaemia; grade ≥3 myocardial infarction, peripheral ischaemia, or visceral arterial ischaemia; and grade ≥4 selected thromboembolic events [cerebrovascular event, arterial insufficiency]).

    Measured: 7 years

Timeline

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

  1. First posted28 Sep 2006 (estimated)
  2. Study startAug 2006
  3. Primary completion25 Aug 2016
  4. Study completionApr 2025 (estimated)

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
Double blind
Who is masked
Participant, Investigator
Enrolment
3,966 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00382070
Sponsor's protocol ID
NSABP B-42
Other IDs
U10CA012027
Status last verified
Mar 2024
First submitted
26 Sep 2006
Last updated
22 Mar 2024
Data monitoring committee
Yes

Publications

  • Mamounas EP, Lembersky B, Jeong JH, Cronin W, Harkins B, Geyer C, Wickerham DL, Paik S, Costantino J, Wolmark N. NSABP B-42: a clinical trial to determine the efficacy of five years of letrozole compared with placebo in patients completing five years of hormonal therapy consisting of an aromatase inhibitor (AI) or tamoxifen followed by an AI in prolonging disease-free survival in postmenopausal women with hormone receptor-positive breast cancer. Clin Breast Cancer. 2006 Dec;7(5):416-21. doi: 10.3816/CBC.2006.n.061. No abstract available.

    PubMed 17239269

  • Rastogi P, Bandos H, Lucas PC, van 't Veer LJ, Wei JJ, Geyer CE Jr, Fehrenbacher L, Chia SKL, Brufsky AM, Walshe JM, Soori GS, Dakhil SR, Paik S, Swain SM, Menicucci AR, Audeh MW, Wolmark N, Mamounas EP. Utility of the 70-Gene MammaPrint Assay for Prediction of Benefit From Extended Letrozole Therapy in the NRG Oncology/NSABP B-42 Trial. J Clin Oncol. 2024 Oct 20;42(30):3561-3569. doi: 10.1200/JCO.23.01995. Epub 2024 Jul 24.

    PubMed 39047219

  • Mamounas EP, Bandos H, Lembersky BC, Jeong JH, Geyer CE Jr, Rastogi P, Fehrenbacher L, Graham ML, Chia SK, Brufsky AM, Walshe JM, Soori GS, Dakhil SR, Seay TE, Wade JL 3rd, McCarron EC, Paik S, Swain SM, Wickerham DL, Wolmark N. Use of letrozole after aromatase inhibitor-based therapy in postmenopausal breast cancer (NRG Oncology/NSABP B-42): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Jan;20(1):88-99. doi: 10.1016/S1470-2045(18)30621-1. Epub 2018 Nov 30.

    PubMed 30509771

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Letrozole in people with Breast Cancer, run by NSABP Foundation Inc at 806 sites in 3 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: status not confirmed, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 806 sites in United States, Canada, Ireland. 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. Some participants in this study may receive a placebo. 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 20 May 2021). 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?

Disease-free Survival (time frame: 7 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 NCT00382070, which also lists 3 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 22 Mar 2024.

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