Exemestane in Treating Postmenopausal Women With Resected Stage I, Stage II, or Stage IIIA Breast Cancer Who Have Completed 5 Years of Tamoxifen

NCT00016432 | Completed Phase 3

• 2 other identifiers: NSABP B-33CDR0000068640
• Study Type: interventional
• Target: 1,598
• Locations: 3 countries
• Sites: 162

Brief Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen by the tumor cells. It is not yet known whether exemestane is effective in preventing the recurrence of breast cancer. 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.

Conditions

Breast Cancer

Keywords

stage I breast cancer; stage II breast cancer; stage IIIA breast cancer

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  Every 12 months until breast cancer recurrence, second primary cancer or death from any cause.

Secondary Outcomes (3)

• Overall survival

  Death from any cause

• Time to treatment failure

  time from randomization to recurrence or contralateral second primary cancer

• Bone measure as measured by total alkaline phosphatase, fracture history, and height measurement

  measurements taken at regular intervals from randomization through 6 years following randomiztion

Study Arms (2)

Group 1

EXPERIMENTAL

Exemestane

Drug: exemestane

Group 2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

exemestane DRUG

25 mg for 5 years

Group 1

Placebo DRUG

Placebo

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NSABP Foundation Inc: lead
• National Cancer Institute (NCI): collaborator

Study Sites (162)

Comprehensive Cancer Institute of Huntsville

Huntsville, Alabama, 35801, United States

Location

CCOP - Greater Phoenix

Phoenix, Arizona, 85006-2726, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

California Cancer Center

Fresno, California, 93720, United States

Location

Sutter Health Western Division Cancer Research Group

Greenbrae, California, 94904, United States

Location

Scripps Cancer Center

La Jolla, California, 92037, United States

Location

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

Loma Linda University Cancer Institute

Loma Linda, California, 92354, United States

Location

Pacific Shores Medical Group

Long Beach, California, 90813, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Comprehensive Cancer Centers of the Desert

Palm Springs, California, 92262, United States

Location

Sutter Cancer Center

Sacramento, California, 95816, United States

Location

Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego

San Diego, California, 92120, United States

Location

CCOP - Santa Rosa Memorial Hospital

Santa Rosa, California, 95403, United States

Location

Stanford University Medical Center

Stanford, California, 94305-5408, United States

Location

Kaiser Permanente Medical Center - Vallejo

Vallejo, California, 94589, United States

Location

University of Colorado Cancer Center

Denver, Colorado, 80010, United States

Location

CCOP - Colorado Cancer Research Program, Incorporated

Denver, Colorado, 80224, United States

Location

University of Connecticut

Farmington, Connecticut, 06032, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102-5037, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19899, United States

Location

George Washington University Medical Center

Washington D.C., District of Columbia, 20037, United States

Location

Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

Halifax Medical Center

Daytona Beach, Florida, 32114, United States

Location

Baptist Regional Cancer Institute - Jacksonville

Jacksonville, Florida, 32207, United States

Location

Sylvester Cancer Center, University of Miami

Miami, Florida, 33136, United States

Location

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

MD Anderson Cancer Center Orlando

Orlando, Florida, 32806, United States

Location

Cancer Research Network Inc.

Plantation, Florida, 33324, United States

Location

Oncology Hematology Consultants

Sarasota, Florida, 34239, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

Dwight David Eisenhower Army Medical Center

Fort Gordon, Georgia, 30905-5650, United States

Location

Cancer Center of Hawaii

Honolulu, Hawaii, 96826, United States

Location

North Idaho Cancer Center

Coeur d'Alene, Idaho, 83814, United States

Location

Illinois Oncology, Ltd.

Belleville, Illinois, 62221, United States

Location

Rush-Presbyterian-St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

Illinois Masonic Medical Center

Chicago, Illinois, 60657, United States

Location

CCOP - Central Illinois

Decatur, Illinois, 62526, United States

Location

Alexian Brothers Medical Center

Elk Grove Village, Illinois, 60007, United States

Location

CCOP - Evanston

Evanston, Illinois, 60201, United States

Location

West Suburban Hospital Medical Center

Oak Park, Illinois, 60302, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61602, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Clarian Health Partners Inc.

Indianapolis, Indiana, 46206-1367, United States

Location

St. Vincent Hospital and Health Care Center

Indianapolis, Indiana, 46260, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Genesis Medical Center

Davenport, Iowa, 52803, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242-1009, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

Lucille Parker Markey Cancer Center, University of Kentucky

Lexington, Kentucky, 43213, United States

Location

Norton Healthcare System

Louisville, Kentucky, 40202-5070, United States

Location

Consultants in Blood Disorders and Cancer

Louisville, Kentucky, 40207, United States

Location

Louisiana State University Medical Center - New Orleans

New Orleans, Louisiana, 70112, United States

Location

Tulane University Medical Center

New Orleans, Louisiana, 70112, United States

Location

CCOP - Ochsner

New Orleans, Louisiana, 70121, United States

Location

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

Franklin Square Hospital Center

Baltimore, Maryland, 21237, United States

Location

National Naval Medical Center

Bethesda, Maryland, 20889-5000, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Lahey Clinic - Burlington

Burlington, Massachusetts, 01805, United States

Location

Berkshire Medical Center

Pittsfield, Massachusetts, 01201, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Michigan State University

East Lansing, Michigan, 48824, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Providence Hospital - Southfield

Southfield, Michigan, 48075-9975, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55415, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Ellis Fischel Cancer Center - Columbia

Columbia, Missouri, 65203, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65807, United States

Location

St. Louis University Health Sciences Center

St Louis, Missouri, 63110-0250, United States

Location

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, 63141, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Methodist Hospital Cancer Center - Omaha

Omaha, Nebraska, 68114, United States

Location

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

CCOP - Northern New Jersey

Hackensack, New Jersey, 07601, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

MBCCOP - University of New Mexico HSC

Albuquerque, New Mexico, 87131, United States

Location

New York Oncology Hematology, P.C.

Albany, New York, 12208, United States

Location

Glens Falls Hospital

Glens Falls, New York, 12801, United States

Location

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

Syracuse, New York, 13217, United States

Location

Lincoln Medical and Mental Health Center

The Bronx, New York, 10451, United States

Location

MBCCOP-Our Lady of Mercy Cancer Center

The Bronx, New York, 10466, United States

Location

Alamance Cancer Center

Burlington, North Carolina, 27216, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

East Carolina University School of Medicine

Greenville, North Carolina, 27858-4354, United States

Location

CCOP - Southeast Cancer Control Consortium

Winston-Salem, North Carolina, 27104-4241, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

CCOP - Merit Care Hospital

Fargo, North Dakota, 58122, United States

Location

Akron City Hospital

Akron, Ohio, 44309, United States

Location

Aultman Cancer Center

Canton, Ohio, 44710, United States

Location

Jewish Hospital of Cincinnati, Inc.

Cincinnati, Ohio, 45236, United States

Location

Barrett Cancer Center

Cincinnati, Ohio, 45267-0502, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

CCOP - Columbus

Columbus, Ohio, 43206, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

CCOP - Dayton

Kettering, Ohio, 45429, United States

Location

CCOP - Toledo Community Hospital

Toledo, Ohio, 43623-3456, United States

Location

South Pointe Hospital - Cancer Care Center

Warrensville Heights, Ohio, 44122, United States

Location

CCOP - Oklahoma

Tulsa, Oklahoma, 74136, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97213, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Albert Einstein Cancer Center

Philadelphia, Pennsylvania, 19141, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212-4772, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213-3489, United States

Location

Reading Hospital and Medical Center

Reading, Pennsylvania, 19612-6052, United States

Location

Mercy Hospital Cancer Center - Scranton

Scranton, Pennsylvania, 18501, United States

Location

CCOP - MainLine Health

Wynnewood, Pennsylvania, 19096, United States

Location

York Cancer Center

York, Pennsylvania, 17315, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57104, United States

Location

Thompson Cancer Survival Center

Knoxville, Tennessee, 37916, United States

Location

Center for Oncology Research and Treatment, Medical City Hospital

Dallas, Texas, 75230, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, 79410-1894, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

Utah Valley Regional Medical Center - Provo

Provo, Utah, 84604, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Green Mountain Oncology Group

Bennington, Vermont, 05201, United States

Location

Vermont Cancer Center

Burlington, Vermont, 05405-0075, United States

Location

Virginia Oncology Associates - Newport News

Newport News, Virginia, 23606, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

Oncology and Hematology Associates of Southwest Virginia, Inc.

Roanoke, Virginia, 24014, United States

Location

CCOP - Virginia Mason Research Center

Seattle, Washington, 98101, United States

Location

Puget Sound Oncology Consortium

Seattle, Washington, 98109, United States

Location

CCOP - Northwest

Tacoma, Washington, 98405-0986, United States

Location

Camcare Health

Charleston, West Virginia, 25304, United States

Location

Camden-Clark Memorial Hospital

Parkersburg, West Virginia, 26102, United States

Location

St. Vincent Hospital

Green Bay, Wisconsin, 54307-3508, United States

Location

CCOP - Marshfield Medical Research and Education Foundation

Marshfield, Wisconsin, 54449, United States

Location

St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Tom Baker Cancer Center - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

British Columbia Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Credit Valley Hospital

Mississauga, Ontario, L5M 2N1, Canada

Location

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, Canada

Location

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2L-4M1, Canada

Location

Royal Victoria Hospital - Montreal

Montreal, Quebec, H3A 1A1, Canada

Location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Jewish General Hospital - Montreal

Montreal, Quebec, H3T 1E2, Canada

Location

St. Mary's Hospital Center

Montreal, Quebec, H3T 1M5, Canada

Location

Hopital du Saint-Sacrement, Quebec

Québec, Quebec, G1S 4L8, Canada

Location

MBCCOP - San Juan

San Juan, 00927-5800, Puerto Rico

Location

Related Publications (2)

• 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.

  PMID: 18332472 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

exemestane

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Norman Wolmark, MD

  NSABP Foundation Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: May 6, 2001
• First Posted: January 27, 2003
• Study Start: May 1, 2001
• Primary Completion: October 1, 2003
• Study Completion: February 1, 2011
• Last Updated: April 19, 2011

Record last verified: 2011-04

Locations

US (150); PR (1); CA (11)