Exemestane in Treating Postmenopausal Women With Resected Stage I, Stage II, or Stage IIIA Breast Cancer Who Have Completed 5 Years of Tamoxifen
NCT ID: NCT00016432
Last Updated: 2011-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1598 participants
INTERVENTIONAL
2001-05-31
2011-02-28
Brief Summary
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PURPOSE: Randomized phase III trial to study the effectiveness of exemestane in preventing cancer recurrence in postmenopausal women who have resected stage I, stage II, or stage IIIA breast cancer and have completed 5 years of tamoxifen.
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Detailed Description
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* Determine whether the administration of 5 years of exemestane after 5 years of tamoxifen therapy is more effective than 5 years of prior tamoxifen therapy alone in prolonging disease-free survival, overall survival, and time to treatment failure in postmenopausal women with resected stage I, II, or IIIA breast cancer.
* Determine the effect of tamoxifen withdrawal on bone, in terms of height, fractures, and total alkaline phosphatase in these patients and on bone mineral density and bone biochemical markers in a subset of patients.
* Determine the effect of exemestane on bone loss after tamoxifen withdrawal in these patients.
* Evaluate the quality of life of a subset of these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral exemestane daily for 5 years.
* Arm II (closed as of 10/15/03): Patients receive an oral placebo daily for 5 years.
Quality of life is assessed at baseline and then every 6 months for 5.5 years.
Patients are followed every 6 months for 6 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 3,000 patients will be accrued for this study within 3 years and 4 months.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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Group 1
Exemestane
exemestane
25 mg for 5 years
Group 2
Placebo
Placebo
Placebo
Interventions
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exemestane
25 mg for 5 years
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed invasive adenocarcinoma of the breast at time of original diagnosis
* Tumor confined to the breast and ipsilateral axilla on clinical exam (T1-3, N0-1, M0) (stage I-IIIA)
* No ipsilateral lymph nodes clinically fixed to one another or to other structures (N2 disease) at time of original diagnosis
* Prior surgical resection, including 1 of the following:
* Total mastectomy and axillary dissection (modified radical mastectomy) OR
* Lumpectomy and axillary dissection
* Prior post-lumpectomy breast radiotherapy required
* Prior sentinel node biopsy allowed with the exception of the following:
* If any sentinel node is histologically positive by hematoxylin and eosin (H \& E) OR histologically suspicious on H \& E and confirmed positive by immunohistochemistry then the patient must have a complete axillary dissection
* Previously resected margins must be clear of invasive tumor and ductal carcinoma in situ
* Currently disease free
* Previously treated with tamoxifen for 57-66 months
* Completed tamoxifen within the past 180 days
* No bilateral malignancy or mass in the opposite breast suspicious for malignancy unless biopsy proven negative
* No local, regional, or distant recurrence of disease or second primary breast malignancy (including contralateral breast cancer)
* No advanced disease at time of original diagnosis (e.g., ulceration, erythema, infiltration of the skin or underlying chest wall \[complete fixation\], peau d'orange, or skin edema of any magnitude)
* Tethering or dimpling of the skin or nipple inversion allowed
* Current skeletal pain allowed if a bone scan and/or radiologic exam is negative for metastatic disease
* Hormone receptor status:
* Primary tumor estrogen receptor (ER) positive AND/OR
* Progesterone receptor positive
* Borderline ER positive tumors allowed if previously treated with tamoxifen
PATIENT CHARACTERISTICS:
Age:
* Postmenopausal
Sex:
* Female
Menopausal status:
* Postmenopausal, defined as 1 of the following:
* Prior bilateral oophorectomy
* Absence of spontaneous menstrual cycle for more than 1 year
* Follicle-stimulating hormone within the postmenopausal range if under 55 and had a prior hysterectomy without a bilateral oophorectomy
Performance status:
* Not specified
Life expectancy:
* At least 10 years
Hematopoietic:
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin normal
Hepatic:
* Bilirubin less than 2 times upper limit of normal (ULN)
* SGOT or SGPT no greater than 2.5 times ULN
* Alkaline phosphatase less than 2 times ULN
* No systemic hepatic disease that would preclude study participation
Renal:
* Creatinine no greater than 1.5 times ULN
* No systemic renal disease that would preclude study participation
Cardiovascular:
* No systemic cardiovascular disease that would preclude study participation
Other:
* No other malignancy within the past 5 years except effectively treated squamous cell or basal cell skin cancer, surgically treated carcinoma in situ of the cervix, or surgically treated lobular carcinoma in situ of the ipsilateral or contralateral breast
* No nonmalignant systemic disease that would preclude study participation
* No psychiatric or addictive disorder that would preclude informed consent
* Not pregnant
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Prior adjuvant chemotherapy allowed if administered concurrently with or prior to tamoxifen
Endocrine therapy:
* See Disease Characteristics
* No concurrent estrogen, progesterone, clomiphene, testosterone, gonadotropin-releasing hormone, oral contraceptives, selective estrogen-receptor modulators, or dehydroepiandrosterone (DHEA)
* Estring or estrogen vaginal cream at 0.3 mg or 1/8 of an applicator applied vaginally 3 times a week allowed
* No other concurrent systemic hormonal therapy (e.g., tamoxifen or raloxifene)
Radiotherapy:
* See Disease Characteristics
* Prior post-mastectomy loco-regional radiotherapy or post-lumpectomy regional radiotherapy allowed
Surgery:
* See Disease Characteristics
Other:
* Prior participation in other adjuvant NSABP study allowed if study was reported in peer-review publication or tamoxifen was not a study drug
* Concurrent bisphosphonates or calcitonin for prevention or treatment of osteoporosis allowed
* Concurrent statins (simvastatin, pravastatin, fluvastatin, atorvastatin, or lovastatin) or other drugs to control lipid levels allowed
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
NSABP Foundation Inc
NETWORK
Responsible Party
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NSABP Foundation, Inc.
Principal Investigators
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Norman Wolmark, MD
Role: PRINCIPAL_INVESTIGATOR
NSABP Foundation Inc
Locations
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Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, United States
CCOP - Greater Phoenix
Phoenix, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
California Cancer Center
Fresno, California, United States
Sutter Health Western Division Cancer Research Group
Greenbrae, California, United States
Scripps Cancer Center
La Jolla, California, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Loma Linda University Cancer Institute
Loma Linda, California, United States
Pacific Shores Medical Group
Long Beach, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Chao Family Comprehensive Cancer Center
Orange, California, United States
Comprehensive Cancer Centers of the Desert
Palm Springs, California, United States
Sutter Cancer Center
Sacramento, California, United States
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
San Diego, California, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States
Stanford University Medical Center
Stanford, California, United States
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, United States
University of Colorado Cancer Center
Denver, Colorado, United States
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States
University of Connecticut
Farmington, Connecticut, United States
Hartford Hospital
Hartford, Connecticut, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
George Washington University Medical Center
Washington D.C., District of Columbia, United States
Morton Plant Hospital
Clearwater, Florida, United States
Halifax Medical Center
Daytona Beach, Florida, United States
Baptist Regional Cancer Institute - Jacksonville
Jacksonville, Florida, United States
Sylvester Cancer Center, University of Miami
Miami, Florida, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
MD Anderson Cancer Center Orlando
Orlando, Florida, United States
Cancer Research Network Inc.
Plantation, Florida, United States
Oncology Hematology Consultants
Sarasota, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Medical College of Georgia
Augusta, Georgia, United States
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, United States
Cancer Center of Hawaii
Honolulu, Hawaii, United States
North Idaho Cancer Center
Coeur d'Alene, Idaho, United States
Illinois Oncology, Ltd.
Belleville, Illinois, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States
Illinois Masonic Medical Center
Chicago, Illinois, United States
CCOP - Central Illinois
Decatur, Illinois, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States
CCOP - Evanston
Evanston, Illinois, United States
West Suburban Hospital Medical Center
Oak Park, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
Clarian Health Partners Inc.
Indianapolis, Indiana, United States
St. Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Genesis Medical Center
Davenport, Iowa, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
CCOP - Wichita
Wichita, Kansas, United States
Lucille Parker Markey Cancer Center, University of Kentucky
Lexington, Kentucky, United States
Norton Healthcare System
Louisville, Kentucky, United States
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States
Louisiana State University Medical Center - New Orleans
New Orleans, Louisiana, United States
Tulane University Medical Center
New Orleans, Louisiana, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
Eastern Maine Medical Center
Bangor, Maine, United States
Franklin Square Hospital Center
Baltimore, Maryland, United States
National Naval Medical Center
Bethesda, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Lahey Clinic - Burlington
Burlington, Massachusetts, United States
Berkshire Medical Center
Pittsfield, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Michigan State University
East Lansing, Michigan, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Providence Hospital - Southfield
Southfield, Michigan, United States
CCOP - Duluth
Duluth, Minnesota, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
St. Louis University Health Sciences Center
St Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Methodist Hospital Cancer Center - Omaha
Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
CCOP - Northern New Jersey
Hackensack, New Jersey, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, United States
New York Oncology Hematology, P.C.
Albany, New York, United States
Glens Falls Hospital
Glens Falls, New York, United States
Staten Island University Hospital
Staten Island, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States
Lincoln Medical and Mental Health Center
The Bronx, New York, United States
MBCCOP-Our Lady of Mercy Cancer Center
The Bronx, New York, United States
Alamance Cancer Center
Burlington, North Carolina, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
East Carolina University School of Medicine
Greenville, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
CCOP - Merit Care Hospital
Fargo, North Dakota, United States
Akron City Hospital
Akron, Ohio, United States
Aultman Cancer Center
Canton, Ohio, United States
Jewish Hospital of Cincinnati, Inc.
Cincinnati, Ohio, United States
Barrett Cancer Center
Cincinnati, Ohio, United States
Ireland Cancer Center
Cleveland, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
CCOP - Dayton
Kettering, Ohio, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, United States
South Pointe Hospital - Cancer Care Center
Warrensville Heights, Ohio, United States
CCOP - Oklahoma
Tulsa, Oklahoma, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Reading Hospital and Medical Center
Reading, Pennsylvania, United States
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States
York Cancer Center
York, Pennsylvania, United States
CCOP - Greenville
Greenville, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, United States
Center for Oncology Research and Treatment, Medical City Hospital
Dallas, Texas, United States
Simmons Cancer Center - Dallas
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Green Mountain Oncology Group
Bennington, Vermont, United States
Vermont Cancer Center
Burlington, Vermont, United States
Virginia Oncology Associates - Newport News
Newport News, Virginia, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
Massey Cancer Center
Richmond, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, United States
Puget Sound Oncology Consortium
Seattle, Washington, United States
CCOP - Northwest
Tacoma, Washington, United States
Camcare Health
Charleston, West Virginia, United States
Camden-Clark Memorial Hospital
Parkersburg, West Virginia, United States
St. Vincent Hospital
Green Bay, Wisconsin, United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
Credit Valley Hospital
Mississauga, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Royal Victoria Hospital - Montreal
Montreal, Quebec, Canada
Montreal General Hospital
Montreal, Quebec, Canada
Jewish General Hospital - Montreal
Montreal, Quebec, Canada
St. Mary's Hospital Center
Montreal, Quebec, Canada
Hopital du Saint-Sacrement, Quebec
Québec, Quebec, Canada
MBCCOP - San Juan
San Juan, , Puerto Rico
Countries
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References
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Mamounas EP, Jeong JH, Wickerham DL, Smith RE, Ganz PA, Land SR, Eisen A, Fehrenbacher L, Farrar WB, Atkins JN, Pajon ER, Vogel VG, Kroener JF, Hutchins LF, Robidoux A, Hoehn JL, Ingle JN, Geyer CE Jr, Costantino JP, Wolmark N. Benefit from exemestane as extended adjuvant therapy after 5 years of adjuvant tamoxifen: intention-to-treat analysis of the National Surgical Adjuvant Breast And Bowel Project B-33 trial. J Clin Oncol. 2008 Apr 20;26(12):1965-71. doi: 10.1200/JCO.2007.14.0228. Epub 2008 Mar 10.
Mamounas E, Jeong J-H, Wickerham L, et al.: Benefit from exemestane (EXE) as extended adjuvant therapy after 5 years of tamoxifen (TAM): intent-to-treat analysis of NSABP B-33. [Abstract] Breast Cancer Res Treat 100 (Suppl 1): A-49, S22, 2006.
Other Identifiers
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CDR0000068640
Identifier Type: -
Identifier Source: secondary_id
NSABP B-33
Identifier Type: -
Identifier Source: org_study_id
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