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

A Randomized Trial Evaluating The Effect Of Exemestane In Clinical Stage T1-3 N0-1 M0 Postmenopausal Breast Cancer Patients Completing At Least Five Years Of Tamoxifen Therapy

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Placebo; Drug: exemestane

Detailed Description

OBJECTIVES:

• 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.

• Study Type: Interventional
• Enrollment (Actual): 1598
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker Cancer Center - Calgary
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • British Columbia Cancer Agency
  • Ontario
    • Mississauga, Ontario, Canada, L5M 2N1
      • Credit Valley Hospital
    • Toronto, Ontario, Canada
      • Toronto Sunnybrook Regional Cancer Centre
  • Quebec
    • Montreal, Quebec, Canada, H3G 1A4
      • Montreal General Hospital
    • Montreal, Quebec, Canada, H3A 1A1
      • Royal Victoria Hospital - Montreal
    • Montreal, Quebec, Canada, H2L-4M1
      • Centre Hospitalier de l'Universite de Montreal
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital - Montreal
    • Montreal, Quebec, Canada, H3T 1M5
      • St. Mary's Hospital Center
    • Quebec City, Quebec, Canada, G1S 4L8
      • Hopital du Saint-Sacrement, Quebec
• Puerto Rico
  • San Juan, Puerto Rico, 00927-5800
    • MBCCOP - San Juan
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Comprehensive Cancer Institute of Huntsville
  • Arizona
    • Phoenix, Arizona, United States, 85006-2726
      • CCOP - Greater Phoenix
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
  • California
    • Duarte, California, United States, 91010-3000
      • City of Hope Comprehensive Cancer Center
    • Fresno, California, United States, 93720
      • California Cancer Center
    • Greenbrae, California, United States, 94904
      • Sutter Health Western Division Cancer Research Group
    • La Jolla, California, United States, 92093-0658
      • Rebecca and John Moores UCSD Cancer Center
    • La Jolla, California, United States, 92037
      • Scripps Cancer Center
    • Loma Linda, California, United States, 92354
      • Loma Linda University Cancer Institute
    • Long Beach, California, United States, 90813
      • Pacific Shores Medical Group
    • Los Angeles, California, United States, 90095-1781
      • Jonsson Comprehensive Cancer Center, UCLA
    • Orange, California, United States, 92868
      • Chao Family Comprehensive Cancer Center
    • Palm Springs, California, United States, 92262
      • Comprehensive Cancer Centers of the Desert
    • Sacramento, California, United States, 95816
      • Sutter Cancer Center
    • San Diego, California, United States, 92120
      • Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
    • Santa Rosa, California, United States, 95403
      • CCOP - Santa Rosa Memorial Hospital
    • Stanford, California, United States, 94305-5408
      • Stanford University Medical Center
    • Vallejo, California, United States, 94589
      • Kaiser Permanente Medical Center - Vallejo
  • Colorado
    • Denver, Colorado, United States, 80010
      • University of Colorado Cancer Center
    • Denver, Colorado, United States, 80224
      • CCOP - Colorado Cancer Research Program, Incorporated
  • Connecticut
    • Farmington, Connecticut, United States, 06032
      • University of Connecticut
    • Hartford, Connecticut, United States, 06102-5037
      • Hartford Hospital
  • Delaware
    • Newark, Delaware, United States, 19899
      • CCOP - Christiana Care Health Services
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University Medical Center
  • Florida
    • Clearwater, Florida, United States, 33756
      • Morton Plant Hospital
    • Daytona Beach, Florida, United States, 32114
      • Halifax Medical Center
    • Jacksonville, Florida, United States, 32207
      • Baptist Regional Cancer Institute - Jacksonville
    • Miami, Florida, United States, 33136
      • Sylvester Cancer Center, University of Miami
    • Miami Beach, Florida, United States, 33140
      • CCOP - Mount Sinai Medical Center
    • Orlando, Florida, United States, 32806
      • MD Anderson Cancer Center Orlando
    • Plantation, Florida, United States, 33324
      • Cancer Research Network Inc.
    • Sarasota, Florida, United States, 34239
      • Oncology Hematology Consultants
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University School of Medicine
    • Augusta, Georgia, United States, 30912
      • Medical College of Georgia
    • Fort Gordon, Georgia, United States, 30905-5650
      • Dwight David Eisenhower Army Medical Center
  • Hawaii
    • Honolulu, Hawaii, United States, 96826
      • Cancer Center of Hawaii
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814
      • North Idaho Cancer Center
  • Illinois
    • Belleville, Illinois, United States, 62221
      • Illinois Oncology, Ltd.
    • Chicago, Illinois, United States, 60612
      • Rush-Presbyterian-St. Luke's Medical Center
    • Chicago, Illinois, United States, 60657
      • Illinois Masonic Medical Center
    • Decatur, Illinois, United States, 62526
      • CCOP - Central Illinois
    • Elk Grove Village, Illinois, United States, 60007
      • Alexian Brothers Medical Center
    • Evanston, Illinois, United States, 60201
      • CCOP - Evanston
    • Oak Park, Illinois, United States, 60302
      • West Suburban Hospital Medical Center
    • Peoria, Illinois, United States, 61602
      • CCOP - Illinois Oncology Research Association
    • Urbana, Illinois, United States, 61801
      • CCOP - Carle Cancer Center
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • St. Vincent Hospital and Health Care Center
    • Indianapolis, Indiana, United States, 46206-1367
      • Clarian Health Partners Inc.
    • South Bend, Indiana, United States, 46601
      • CCOP - Northern Indiana CR Consortium
  • Iowa
    • Davenport, Iowa, United States, 52803
      • Genesis Medical Center
    • Des Moines, Iowa, United States, 50309-1016
      • CCOP - Iowa Oncology Research Association
    • Iowa City, Iowa, United States, 52242-1009
      • Holden Comprehensive Cancer Center
  • Kansas
    • Wichita, Kansas, United States, 67214-3882
      • CCOP - Wichita
  • Kentucky
    • Lexington, Kentucky, United States, 43213
      • Lucille Parker Markey Cancer Center, University of Kentucky
    • Louisville, Kentucky, United States, 40207
      • Consultants in Blood Disorders and Cancer
    • Louisville, Kentucky, United States, 40202-5070
      • Norton Healthcare System
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • CCOP - Ochsner
    • New Orleans, Louisiana, United States, 70112
      • Tulane University Medical Center
    • New Orleans, Louisiana, United States, 70112
      • Louisiana State University Medical Center - New Orleans
  • Maine
    • Bangor, Maine, United States, 04401
      • Eastern Maine Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Franklin Square Hospital Center
    • Bethesda, Maryland, United States, 20889-5000
      • National Naval Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic - Burlington
    • Pittsfield, Massachusetts, United States, 01201
      • Berkshire Medical Center
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • CCOP - Michigan Cancer Research Consortium
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • East Lansing, Michigan, United States, 48824
      • Michigan State University
    • Grand Rapids, Michigan, United States, 49503
      • CCOP - Grand Rapids
    • Kalamazoo, Michigan, United States, 49007-3731
      • CCOP - Kalamazoo
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
    • Southfield, Michigan, United States, 48075-9975
      • Providence Hospital - Southfield
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • CCOP - Duluth
    • Minneapolis, Minnesota, United States, 55415
      • Abbott-Northwestern Hospital
    • Saint Louis Park, Minnesota, United States, 55416
      • CCOP - Metro-Minnesota
  • Missouri
    • Columbia, Missouri, United States, 65203
      • Ellis Fischel Cancer Center - Columbia
    • Kansas City, Missouri, United States, 64131
      • CCOP - Kansas City
    • Saint Louis, Missouri, United States, 63110-0250
      • St. Louis University Health Sciences Center
    • Saint Louis, Missouri, United States, 63141
      • CCOP - St. Louis-Cape Girardeau
    • Springfield, Missouri, United States, 65807
      • CCOP - Cancer Research for the Ozarks
  • Montana
    • Billings, Montana, United States, 59101
      • CCOP - Montana Cancer Consortium
  • Nebraska
    • Omaha, Nebraska, United States, 68106
      • CCOP - Missouri Valley Cancer Consortium
    • Omaha, Nebraska, United States, 68114
      • Methodist Hospital Cancer Center - Omaha
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • CCOP - Southern Nevada Cancer Research Foundation
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • CCOP - Northern New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • Cancer Institute of New Jersey
    • Newark, New Jersey, United States, 07112
      • Newark Beth Israel Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • MBCCOP - University of New Mexico HSC
  • New York
    • Albany, New York, United States, 12208
      • New York Oncology Hematology, P.C.
    • Bronx, New York, United States, 10451
      • Lincoln Medical and Mental Health Center
    • Bronx, New York, United States, 10466
      • MBCCOP-Our Lady of Mercy Cancer Center
    • Glens Falls, New York, United States, 12801
      • Glens Falls Hospital
    • Staten Island, New York, United States, 10305
      • Staten Island University Hospital
    • Syracuse, New York, United States, 13217
      • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
  • North Carolina
    • Burlington, North Carolina, United States, 27216
      • Alamance Cancer Center
    • Chapel Hill, North Carolina, United States, 27599-7295
      • Lineberger Comprehensive Cancer Center, UNC
    • Greenville, North Carolina, United States, 27858-4354
      • East Carolina University School of Medicine
    • Winston-Salem, North Carolina, United States, 27104-4241
      • CCOP - Southeast Cancer Control Consortium
    • Winston-Salem, North Carolina, United States, 27157-1082
      • Comprehensive Cancer Center at Wake Forest University
  • North Dakota
    • Fargo, North Dakota, United States, 58122
      • CCOP - Merit Care Hospital
  • Ohio
    • Akron, Ohio, United States, 44309
      • Akron City Hospital
    • Canton, Ohio, United States, 44710
      • Aultman Cancer Center
    • Cincinnati, Ohio, United States, 45267-0502
      • Barrett Cancer Center
    • Cincinnati, Ohio, United States, 45236
      • Jewish Hospital of Cincinnati, Inc.
    • Cleveland, Ohio, United States, 44106-5065
      • Ireland Cancer Center
    • Columbus, Ohio, United States, 43210-1240
      • Arthur G. James Cancer Hospital - Ohio State University
    • Columbus, Ohio, United States, 43206
      • CCOP - Columbus
    • Kettering, Ohio, United States, 45429
      • CCOP - Dayton
    • Toledo, Ohio, United States, 43623-3456
      • CCOP - Toledo Community Hospital
    • Warrensville Heights, Ohio, United States, 44122
      • South Pointe Hospital - Cancer Care Center
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • CCOP - Oklahoma
  • Oregon
    • Portland, Oregon, United States, 97213
      • CCOP - Columbia River Oncology Program
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Hospital
    • Danville, Pennsylvania, United States, 17822-2001
      • Geisinger Medical Center
    • Philadelphia, Pennsylvania, United States, 19141
      • Albert Einstein Cancer Center
    • Philadelphia, Pennsylvania, United States, 19107-5541
      • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
    • Pittsburgh, Pennsylvania, United States, 15213-3489
      • University of Pittsburgh Cancer Institute
    • Pittsburgh, Pennsylvania, United States, 15212-4772
      • Allegheny General Hospital
    • Reading, Pennsylvania, United States, 19612-6052
      • Reading Hospital and Medical Center
    • Scranton, Pennsylvania, United States, 18501
      • Mercy Hospital Cancer Center - Scranton
    • Wynnewood, Pennsylvania, United States, 19096
      • CCOP - MainLine Health
    • York, Pennsylvania, United States, 17315
      • York Cancer Center
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • CCOP - Greenville
    • Spartanburg, South Carolina, United States, 29303
      • CCOP - Upstate Carolina
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • CCOP - Sioux Community Cancer Consortium
  • Tennessee
    • Knoxville, Tennessee, United States, 37916
      • Thompson Cancer Survival Center
  • Texas
    • Dallas, Texas, United States, 75235-9154
      • Simmons Cancer Center - Dallas
    • Dallas, Texas, United States, 75230
      • Center for Oncology Research and Treatment, Medical City Hospital
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Lubbock, Texas, United States, 79410-1894
      • Joe Arrington Cancer Research and Treatment Center
    • San Antonio, Texas, United States, 78284-7811
      • University of Texas Health Science Center at San Antonio
    • Temple, Texas, United States, 76508
      • CCOP - Scott and White Hospital
  • Utah
    • Provo, Utah, United States, 84604
      • Utah Valley Regional Medical Center - Provo
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute
  • Vermont
    • Bennington, Vermont, United States, 05201
      • Green Mountain Oncology Group
    • Burlington, Vermont, United States, 05405-0075
      • Vermont Cancer Center
  • Virginia
    • Newport News, Virginia, United States, 23606
      • Virginia Oncology Associates - Newport News
    • Norfolk, Virginia, United States, 23507
      • Eastern Virginia Medical School
    • Richmond, Virginia, United States, 23298-0037
      • Massey Cancer Center
    • Roanoke, Virginia, United States, 24014
      • Oncology and Hematology Associates of Southwest Virginia, Inc.
  • Washington
    • Seattle, Washington, United States, 98101
      • CCOP - Virginia Mason Research Center
    • Seattle, Washington, United States, 98109
      • Puget Sound Oncology Consortium
    • Tacoma, Washington, United States, 98405-0986
      • CCOP - Northwest
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • Camcare Health
    • Parkersburg, West Virginia, United States, 26102
      • Camden-Clark Memorial Hospital
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54307-3508
      • St. Vincent Hospital
    • Marshfield, Wisconsin, United States, 54449
      • CCOP - Marshfield Medical Research and Education Foundation
    • Milwaukee, Wisconsin, United States, 53215
      • St. Luke's Medical Center
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group 2; Placebo	Drug: Placebo; Placebo
Experimental: Group 1; Exemestane	Drug: exemestane; 25 mg for 5 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disease-free survival	Every 12 months until breast cancer recurrence, second primary cancer or death from any cause.

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: NSABP Foundation Inc
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2001
• Primary Completion (Actual): October 1, 2003
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: May 6, 2001
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): April 19, 2011
• Last Update Submitted That Met QC Criteria: April 18, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: stage IIIA breast cancer; stage II breast cancer; stage I breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Exemestane
• Other Study ID Numbers: NSABP B-33; CDR0000068640