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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


Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Norman Wolmark, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NSABP Foundation, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

NSABP B-33

NCT ID:

NCT00016432

Start Date:

May 2001

Completion Date:

February 2011

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Breast Neoplasms

Name

Location

Akron City HospitalAkron, Ohio  44304
Baylor College of MedicineHouston, Texas  77030
National Naval Medical CenterBethesda, Maryland  20889
George Washington University Medical CenterWashington, District of Columbia  20037
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Chao Family Comprehensive Cancer CenterOrange, California  92868
Stanford University Medical CenterStanford, California  94305-5408
University of Colorado Cancer CenterDenver, Colorado  80262
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Ireland Cancer CenterCleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Simmons Cancer Center - DallasDallas, Texas  75235-9154
St. Luke's Medical CenterMilwaukee, Wisconsin  53215
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
CCOP - WichitaWichita, Kansas  67214-3882
East Carolina University School of MedicineGreenville, North Carolina  27858-4354
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Vermont Cancer CenterBurlington, Vermont  05401-3498
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Northern New JerseyHackensack, New Jersey  07601
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
St. Vincent Hospital and Health Care CenterIndianapolis, Indiana  46260
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
CCOP - DuluthDuluth, Minnesota  55805
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
MD Anderson Cancer Center OrlandoOrlando, Florida  32806
CCOP - OchsnerNew Orleans, Louisiana  70121
CCOP - Merit Care HospitalFargo, North Dakota  58122
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Huntsman Cancer InstituteSalt Lake City, Utah  84112
California Cancer CenterFresno, California  93720
Sutter Health Western Division Cancer Research GroupGreenbrae, California  94904
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
Halifax Medical CenterDaytona Beach, Florida  32114
CCOP - Central IllinoisSpringfield, Illinois  62526
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Newark Beth Israel Medical CenterNewark, New Jersey  07112
CCOP - ColumbusColumbus, Ohio  43206
CCOP - DaytonKettering, Ohio  45429
Lehigh Valley HospitalAllentown, Pennsylvania  18103
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Mercy Hospital Cancer Center - ScrantonScranton, Pennsylvania  18501
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
CCOP - GreenvilleGreenville, South Carolina  29615
Joe Arrington Cancer Research and Treatment CenterLubbock, Texas  79410-1894
Green Mountain Oncology GroupRutland, Vermont  05701
Massey Cancer CenterRichmond, Virginia  23298-0037
St. Vincent HospitalGreen Bay, Wisconsin  54307-3508
CCOP - EvanstonEvanston, Illinois  60201
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
CCOP - Grand RapidsGrand Rapids, Michigan  49503
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - Scott and White HospitalTemple, Texas  76508
CCOP - Marshfield Medical Research and Education FoundationMarshfield, Wisconsin  54449
Baptist Regional Cancer Institute - JacksonvilleJacksonville, Florida  32207
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Dwight David Eisenhower Army Medical CenterFort Gordon, Georgia  30905-5650
Boston Medical CenterBoston, Massachusetts  02118
Providence Hospital - SouthfieldSouthfield, Michigan  48075-9975
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
CCOP - NorthwestTacoma, Washington  98405-0986
Puget Sound Oncology ConsortiumSeattle, Washington  98109
Sutter Cancer CenterSacramento, California  95816
Kaiser Permanente Medical Center - VallejoVallejo, California  94589
Hartford HospitalHartford, Connecticut  06102-5037
Illinois Masonic Medical CenterChicago, Illinois  60657
West Suburban Hospital Medical CenterOak Park, Illinois  60302
Holden Comprehensive Cancer CenterIowa City, Iowa  52242-1009
Lucille Parker Markey Cancer Center, University of KentuckyLexington, Kentucky  40536-0093
Norton Healthcare SystemLouisville, Kentucky  40202-5070
Louisiana State University Medical Center - New OrleansNew Orleans, Louisiana  70112
Eastern Maine Medical CenterBangor, Maine  04401
Franklin Square Hospital CenterBaltimore, Maryland  21237
Lahey Clinic - BurlingtonBurlington, Massachusetts  01805
Berkshire Medical CenterPittsfield, Massachusetts  01201
Baystate Medical CenterSpringfield, Massachusetts  01199
Michigan State UniversityEast Lansing, Michigan  48824
Staten Island University HospitalStaten Island, New York  10305
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Aultman Cancer CenterCanton, Ohio  44710
Jewish Hospital of Cincinnati, Inc.Cincinnati, Ohio  45236
CCOP - OklahomaTulsa, Oklahoma  74136
Allegheny General HospitalPittsburgh, Pennsylvania  15212-4772
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Virginia Oncology Associates - Newport NewsNewport News, Virginia  23606
Eastern Virginia Medical SchoolNorfolk, Virginia  23507
Oncology and Hematology Associates of Southwest Virginia, Inc.Roanoke, Virginia  24014
Camden-Clark Memorial HospitalParkersburg, West Virginia  26102
Comprehensive Cancer Institute of HuntsvilleHuntsville, Alabama  35801
William Beaumont HospitalRoyal Oak, Michigan  48073
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San DiegoSan Diego, California  92120
City of Hope Comprehensive Cancer CenterDuarte, California  91010
CCOP - Colorado Cancer Research Program, IncorporatedDenver, Colorado  80224
Thompson Cancer Survival CenterKnoxville, Tennessee  37916
Comprehensive Cancer Centers of the DesertPalm Springs, California  92262
North Idaho Cancer CenterCoeur d'Alene, Idaho  83814
Clarian Health Partners Inc.Indianapolis, Indiana  46206-1367
Methodist Hospital Cancer Center - OmahaOmaha, Nebraska  68114
Barrett Cancer CenterCincinnati, Ohio  45267-0502
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
York Cancer CenterYork, Pennsylvania  17403
Emory University School of MedicineAtlanta, Georgia  30322
MBCCOP-Our Lady of Mercy Cancer CenterBronx, New York  10466
Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Pacific Shores Medical GroupLong Beach, California  90813
Genesis Medical CenterDavenport, Iowa  52804
Morton Plant HospitalClearwater, Florida  33756
Consultants in Blood Disorders and CancerLouisville, Kentucky  40207
Tulane University Medical CenterNew Orleans, Louisiana  70112
Lincoln Medical and Mental Health CenterBronx, New York  10451
Alamance Cancer CenterBurlington, North Carolina  27216
South Pointe Hospital - Cancer Care CenterWarrensville Heights, Ohio  44122
Camcare HealthCharleston, West Virginia  25304
Alexian Brothers Medical CenterElk Grove Village, Illinois  60007
Loma Linda University Cancer InstituteLoma Linda, California  92354
Cancer Research Network Inc.Plantation, Florida  33324
Medical College of GeorgiaAugusta, Georgia  30912
Center for Oncology Research and Treatment, Medical City HospitalDallas, Texas  75230
Scripps Cancer CenterLa Jolla, California  92037
Illinois Oncology, Ltd.Belleville, Illinois  62221
University of ConnecticutFarmington, Connecticut  06032
Oncology Hematology ConsultantsSarasota, Florida  34239
Cancer Center of HawaiiHonolulu, Hawaii  96826
Henry Ford Health SystemDetroit, Michigan  48202
New York Oncology Hematology, P.C.Albany, New York  12208
Glens Falls HospitalGlens Falls, New York  12801