Full Text View
Tabular View
No Study Results Posted
Related Studies
Exemestane or Anastrozole in Treating Postmenopausal Women Who Have Undergone Surgery for Primary Breast Cancer
This study is ongoing, but not recruiting participants.
First Received: August 6, 2003   Last Updated: May 28, 2009   History of Changes
Sponsor: NCIC Clinical Trials Group
Collaborators: National Cancer Institute (NCI)
North Central Cancer Treatment Group
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
Southwest Oncology Group
International Breast Cancer Study Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00066573
  Purpose

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

PURPOSE: This randomized phase III trial is studying exemestane to see how well it works compared to anastrozole in preventing cancer recurrence in postmenopausal women who have undergone surgery for primary breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: anastrozole
Drug: exemestane
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A Randomized Phase III Trial Of Exemestane Versus Anastrozole In Postmenopausal Women With Receptor Positive Primary Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Event-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Distant disease-free survival [ Designated as safety issue: No ]
  • New primary breast cancer [ Designated as safety issue: No ]
  • Clinical fracture rate [ Designated as safety issue: No ]
  • Cardiovascular morbidity and mortality [ Designated as safety issue: No ]

Estimated Enrollment: 6840
Study Start Date: June 2003
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm I: Experimental
Patients receive oral exemestane (25 mg) once daily for 5 years.
Drug: exemestane
Given orally
Arm II: Active Comparator
Patients receive oral anastrozole (1 mg) once daily for 5 years.
Drug: anastrozole
Given orally

Detailed Description:

OBJECTIVES:

Primary

  • Compare the event-free survival of postmenopausal women with receptor-positive primary breast cancer when treated with exemestane vs anastrozole.

Secondary

  • Compare the overall survival of patients treated with these regimens.
  • Compare the time to distant recurrence in patients treated with these regimens.
  • Compare the incidence of new primary contralateral breast cancer in patients treated with these regimens.
  • Compare the incidence of all clinical fractures, specifically hip and vertebral fractures, in patients treated with these regimens.
  • Compare cardiovascular morbidity and mortality (i.e., significant coronary heart disease, which includes myocardial infarctions and angina requiring percutaneous transluminal coronary angioplasty or coronary artery bypass graft, fatal and nonfatal strokes, and all vascular deaths) in patients treated with these regimens.
  • Correlate therapy induced changes in breast density with plasma hormones and growth factors, drug levels of exemestane and anastrozole, genetic variation and breast cancer recurrence or contralateral events in patients treated with these regimens.
  • Compare the toxic effects of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to lymph node status at diagnosis (negative vs positive vs unknown), prior adjuvant chemotherapy (yes vs no), and herceptin use (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral exemestane (25 mg) once daily for 5 years.
  • Arm II: Patients receive oral anastrozole (1 mg) once daily for 5 years. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months during the first year of study participation and annually thereafter.

PROJECTED ACCRUAL: A total of 6,840 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive breast cancer

    • pT1-3; pNX, pN0-2 or pN3*; M0
    • Neoadjuvant patients are eligible no earlier than 3 weeks or later than 3 months after excisional surgery, provided both the clinical-diagnostic staging of cancer and postsurgical resection-pathologic staging of cancer meet the requirements for primary tumor, regional lymph nodes, and distant metastasis classification NOTE: *Only when the sole basis for this classification is the presence of 10 or more involved axillary lymph nodes
  • Completely resected disease

    • Primary surgery performed at least 3 weeks but no more than 3 months before study entry (if no chemotherapy was given)

      • Primary surgery is defined as the last surgery at which histologic evidence of invasive or in situ disease was present in the pathology specimen
    • Patients with positive sentinel lymph node biopsy are eligible provided they have had a subsequent axillary lymph node dissection
  • No metachronous breast cancer
  • Bilateral mammogram within the past 12 months unless initial surgery was a total mastectomy, in which case only a mammogram of the remaining breast is required
  • No metastases confirmed by 1 of the following methods:

    • Bone scan* (required only if alkaline phosphatase is at least 2 times normal and/or there are symptoms of metastatic disease)
    • Abdominal ultrasound or CT scan (required only if AST/ALT or alkaline phosphatase is at least 2 times normal, unless the elevation is in the bone fraction)
    • Chest x-ray NOTE: *Confirmatory x-ray, CT scan, or MRI required if the bone scan results are questionable
  • No locally recurrent disease
  • No prior or concurrent carcinoma in situ of the contralateral breast treated with partial mastectomy and/or hormonal therapy

    • Patients with prior or concurrent carcinoma in situ of the ipsilateral breast are eligible provided the tumor was completely excised AND they have not received prior hormonal therapy
  • Hormone receptor status:

    • Estrogen receptor- and/or progesterone receptor-positive by immunohistochemistry or tumor receptor content ≥ 10 fmol/mg protein

PATIENT CHARACTERISTICS:

Age

  • Postmenopausal

Sex

  • Female

Menopausal status

  • Postmenopausal prior to chemotherapy, defined as 1 of the following:

    • Over 60 years of age
    • Age 45-59 with spontaneous cessation of menses for more than 1 year prior to study entry
    • Age 45-59 with menses ceasing (secondary to hysterectomy or spontaneously) within the past year AND a follicle-stimulating hormone (FSH) level prior to study entry in the postmenopausal range*
    • Age 45-59, previously on hormone replacement therapy (HRT) and have discontinued HRT upon diagnosis of this malignancy AND has an FSH level prior to study entry in the postmenopausal range*
    • Has undergone bilateral oophorectomy NOTE: *By institutional standards OR > 34.4 IU/L if institutional range is not available)

Performance status

  • ECOG 0-2

Life expectancy

  • At least 5 years

Hematopoietic

  • WBC at least 3,000/mm^3 OR
  • Granulocyte count at least 1,500/mm^3 AND
  • Platelet count at least 100,000/mm^3

Hepatic

  • See Disease Characteristics
  • AST and/or ALT less than 2 times upper limit of normal (ULN)*
  • Alkaline phosphatase less than 2 times ULN* NOTE: *Unless imaging examinations have ruled out metastatic disease

Renal

  • Not specified

Other

  • Able to swallow study medication and have adequate unassisted oral intake in order to maintain reasonable nutrition status
  • No other non-breast malignancy within the past 5 years except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumors with no evidence of disease for at least 5 years
  • No other concurrent medical or psychiatric condition that would preclude study participation and/or interfere with results

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Prior and concurrent trastuzumab (Herceptin®) allowed

Chemotherapy

  • See Disease Characteristics
  • At least 3 weeks but no more than 3 months since prior chemotherapy
  • Prior adjuvant chemotherapy allowed

Endocrine therapy

  • See Disease Characteristics
  • No prior aromatase inhibitor
  • No prior tamoxifen or other selective estrogen receptor modulators (SERMs) except raloxifene

    • At least 3 weeks since prior raloxifene
  • At least 3 weeks since prior and no concurrent over-the-counter products or supplements considered to have an estrogenic effect, including any of the following:

    • Ginseng
    • Ginkgo biloba
    • Black cohosh
    • Dong quai
    • Fortified soy supplements (e.g., phytoestrogen preparations)
  • At least 3 weeks since other prior hormonal therapy or steroids considered to have an estrogenic effect
  • No concurrent estrogens, progesterones, androgens, or SERMs

    • Concurrent intermittent vaginal estrogens (e.g., vagifem, estrogen vaginal cream, testosterone, estradiol vaginal gel, or Estring) allowed if other local measures for intractable vaginal atrophy are insufficient
  • No other concurrent therapy that would have an estrogenic effect, including endocrine therapy, hormonal therapy, or steroid therapy

Radiotherapy

  • See Disease Characteristics
  • Prior adjuvant radiotherapy allowed
  • Concurrent radiotherapy allowed

Surgery

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00066573

  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Ft. Smith, Arkansas, United States, 72903
United States, California
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States, 94704
California Pacific Medical Center - California Campus
San Francisco, California, United States, 94118
CCOP - Santa Rosa Memorial Hospital
Sana Rosa, California, United States, 95405
Desert Regional Medical Center Comprehensive Cancer Center
Palm Springs, California, United States, 92262
Glendale Memorial Hospital Comprehensive Cancer Center
Glendale, California, United States, 91204
Kaiser Foundation Hospital - San Rafael
San Rafael, California, United States, 94903
Kaiser Permanente Medical Center - Santa Rosa
Santa Rosa, California, United States, 95403
Kaiser Permanente Medical Center - Hayward
Hayward, California, United States, 94545
Kaiser Permanente Medical Center - Oakland
Oakland, California, United States, 94611
Kaiser Permanente Medical Center - Redwood City
Redwood City, California, United States, 94063
Kaiser Permanente Medical Center - Richmond
Richmond, California, United States, 94801
Kaiser Permanente Medical Center - Roseville
Roseville, California, United States, 95661
Kaiser Permanente Medical Center - Sacramento
Sacramento, California, United States, 95825
Kaiser Permanente Medical Center - San Francisco Geary Campus
San Francisco, California, United States, 94115
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
Santa Clara, California, United States, 95051
Kaiser Permanente - Fremont
Fremont, California, United States, 94538
Kaiser Permanente Medical Center - Santa Teresa
San Jose, California, United States, 95119
Kaiser Permanente Medical Center - South San Francisco
South San Francisco, California, United States, 94080
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, United States, 94589
Kaiser Permanente Medical Center - Walnut Creek
Walnut Creek, California, United States, 94596
Kaiser Permanente Medical Facility - Stockton
Stockton, California, United States, 95210
South Sacramento Kaiser-Permanente Medical Center
Sacramento, California, United States, 95823
North Bay Cancer Center
Fairfield, California, United States, 94533
Peninsula Medical Center
Burlingame, California, United States, 94010
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
Marin Cancer Institute at Marin General Hospital
Greenbrae, California, United States, 94904
Sutter Health - Western Division Cancer Research Group
Greenbrae, California, United States, 94904
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
United States, Colorado
Front Range Cancer Specialists
Fort Collins, Colorado, United States, 80528
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
United States, District of Columbia
Sibley Memorial Hospital
Washington, District of Columbia, United States, 20016
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
West Florida Cancer Institute at West Florida Hospital - Pensacola
Pensacola, Florida, United States, 32514
United States, Georgia
Augusta Oncology Associates - Walton Way
Augusta, Georgia, United States, 30901
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
United States, Idaho
Kootenai Cancer Center - Coeur d'Alene
Coeur d'Alene, Idaho, United States, 83814
Snake River Oncology of Eastern Idaho PLLC
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453-2699
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States, 61554
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
Community Cancer Center
Normal, Illinois, United States, 61761
Community Hospital of Ottawa
Ottawa, Illinois, United States, 61350
Mason District Hospital
Havana, Illinois, United States, 62644
Eureka Community Hospital
Eureka, Illinois, United States, 61530
Evanston Northwestern Healthcare - Evanston Hospital
Evanston, Illinois, United States, 60201-1781
Galesburg Clinic, PC
Galesburg, Illinois, United States, 61401
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
Graham Hospital
Canton, Illinois, United States, 61520
Hopedale Medical Complex
Hopedale, Illinois, United States, 61747
Illinois Valley Community Hospital
Peru, Illinois, United States, 61354
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Delnor Community Hospital - Geneva
Geneva, Illinois, United States, 60134
McDonough District Hospital
Macomb, Illinois, United States, 61455
Memorial Hospital
Carthage, Illinois, United States, 62321
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, United States, 61350
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615
Resurrection Medical Center
Chicago, Illinois, United States, 60631
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Proctor Hospital
Peoria, Illinois, United States, 61614
Provena St. Mary's Regional Cancer Center - Kankakee
Kankakee, Illinois, United States, 60901
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
Rush University Medical Center
Chicago, Illinois, United States, 60612
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60504
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
St. Margaret's Hospital
Spring Valley, Illinois, United States, 61362
Swedish-American Regional Cancer Center
Rockford, Illinois, United States, 61104-2315
United States, Indiana
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Center for Cancer Care at Goshen General Hospital
Goshen, Indiana, United States, 46526
Bloomington Hospital Regional Cancer Institute
Bloomington, Indiana, United States, 47403
Community Hospital
Munster, Indiana, United States, 46321
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Howard Community Hospital
Kokomo, Indiana, United States, 46904
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Reid Hospital & Health Care Services
Richmond, Indiana, United States, 47374
Saint Joseph Regional Medical Center
South Bend, Indiana, United States, 46617
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States, 46107
United States, Iowa
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States, 52403
Cedar Valley Medical Specialists, PC - West Ridgeway Avenue
Waterloo, Iowa, United States, 50702
Covenant Cancer Treatment Center
Waterloo, Iowa, United States, 50702
Genesis Regional Cancer Center at Genesis Medical Center
Davenport, Iowa, United States, 52803
Heartland Oncology and Hematology
Council Bluffs, Iowa, United States, 51503
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, United States, 52722
McCreery Cancer Center at Ottumwa Regional
Ottumwa, Iowa, United States, 52501
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City, Iowa, United States, 50401
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
United States, Kansas
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67042
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
CCOP - Wichita
Wichita, Kansas, United States, 67214
Southwest Medical Center
Liberal, Kansas, United States, 67901
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503-9985
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States, 40202
United States, Maine
Mercy Hospital
Portland, Maine, United States, 04101
United States, Massachusetts
Addison Gilbert Hospital
Gloucester, Massachusetts, United States, 01930
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
NSMC Cancer Center - Peabody
Peabody, Massachusetts, United States, 01960
Tufts-NEMC Cancer Center
Boston, Massachusetts, United States, 02111
United States, Michigan
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States, 49017
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States, 49503
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
Community Cancer Center of Monroe
Monroe, Michigan, United States, 48162
Dickinson County Healthcare System
Iron Mountain, Michigan, United States, 49801
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States, 49431
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
Haematology-Oncology Associates of Ohio and Michigan, PC
Lambertville, Michigan, United States, 48144
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States, 49221
Holland Community Hospital
Holland, Michigan, United States, 49423
Hackley Hospital
Muskegon, Michigan, United States, 49442
Lakeland Regional Cancer Care Center - St. Joseph
St. Joseph, Michigan, United States, 49085
Mecosta County Medical Center
Big Rapids, Michigan, United States, 49307
Mercy Memorial Hospital - Monroe
Monroe, Michigan, United States, 48162
Metro Health Hospital
Grand Rapids, Michigan, United States, 49506
Munson Medical Center
Traverse City, Michigan, United States, 49684
Oncology Care Associates, PLLC
Saint Joseph, Michigan, United States, 49085
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
United States, Minnesota
CCOP - Duluth
Duluth, Minnesota, United States, 55805
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, United States, 56303
Duluth Clinic Cancer Center - Duluth
Duluth, Minnesota, United States, 55805-1983
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
MeritCare Bemidji
Bemidji, Minnesota, United States, 56601
Miller - Dwan Medical Center
Duluth, Minnesota, United States, 55805
St. Luke's Hospital Cancer Care Center
Duluth, Minnesota, United States, 55805
United States, Missouri
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65802
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
United States, Montana
Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Community Medical Center
Missoula, Montana, United States, 59801
Kalispell Medical Oncology at KRMC
Kalispell, Montana, United States, 59901
Great Falls Clinic - Main Facility
Great Falls, Montana, United States, 59405
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59101
Glacier Oncology, PLLC
Kalispell, Montana, United States, 59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59807
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59807-7877
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
St. James Healthcare Cancer Care
Butte, Montana, United States, 59701
St. Peter's Hospital
Helena, Montana, United States, 59601
St. Vincent Healthcare Cancer Care Services
Billings, Montana, United States, 59101
United States, Nebraska
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
Cancer Resource Center - Lincoln
Lincoln, Nebraska, United States, 68510
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Creighton University Medical Center
Omaha, Nebraska, United States, 68131-2197
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney, Nebraska, United States, 68848-1990
Immanuel Medical Center
Omaha, Nebraska, United States, 68122
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States, 68114
United States, New Hampshire
Center for Cancer Care at Exeter Hospital
Exeter, New Hampshire, United States, 03833
Elliot Regional Cancer Center at Elliot Hospital
Manchester, New Hampshire, United States, 03103
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
Concord, New Hampshire, United States, 03301
Lakes Region General Hospital
Laconia, New Hampshire, United States, 03246
New Hampshire Oncology - Hematology, PA - Hooksett
Hooksett, New Hampshire, United States, 03106
Kingsbury Center for Cancer Care at Cheshire Medical Center
Keene, New Hampshire, United States, 03431
United States, New Jersey
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees, New Jersey, United States, 08043
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States, 08053
Hunterdon Regional Cancer Center at Hunterdon Medical Center
Flemington, New Jersey, United States, 08822
Overlook Hospital
Summit, New Jersey, United States, 07902
St. Barnabas Medical Center Cancer Center
Livingston, New Jersey, United States, 07039
Warren Hospital
Phillipsburg, New Jersey, United States, 08865
United States, New York
Adirondack Cancer Care - Glens Falls
Glens Falls, New York, United States, 12801
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Brookdale University Hospital and Medical Center
Brooklyn, New York, United States, 11212
Finger Lakes Hematology and Oncology
Clifton Springs, New York, United States, 14432
United States, North Carolina
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst, North Carolina, United States, 28374
Kinston Medical Specialists
Kinston, North Carolina, United States, 28501
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States, 28233-3549
United States, North Dakota
Altru Cancer Center at Altru Hospital
Grand Forks, North Dakota, United States, 58201
Mid Dakota Clinic, PC
Bismarck, North Dakota, United States, 58501
Medcenter One Hospital Cancer Care Center
Bismarck, North Dakota, United States, 58501
MeritCare Broadway
Fargo, North Dakota, United States, 58122
CCOP - MeritCare Hospital
Fargo, North Dakota, United States, 58122
United States, Ohio
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Toledo Clinic - Oregon
Oregon, Ohio, United States, 43616
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
CCOP - Columbus
Columbus, Ohio, United States, 43215
CCOP - Dayton
Dayton, Ohio, United States, 45429
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43617
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States, 45505
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Doctors Hospital at Ohio Health
Columbus, Ohio, United States, 43228
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Firelands Regional Medical Center
Sandusky, Ohio, United States, 44870
Flower Hospital Cancer Center
Sylvania, Ohio, United States, 43560
Fulton County Health Center
Wauseon, Ohio, United States, 43567
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States, 43701
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Grandview Hospital
Dayton, Ohio, United States, 45405
Grant Medical Center Cancer Care
Columbus, Ohio, United States, 43215
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States, 43055
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Mercy Cancer Center at Mercy Medical Center
Canton, Ohio, United States, 44708
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
Mercy Medical Center
Springfield, Ohio, United States, 45504
Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Mount Carmel Health - West Hospital
Columbus, Ohio, United States, 43222
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, United States, 43081
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States, 44870
Northwest Ohio Oncology Center
Maumee, Ohio, United States, 43537
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
St. Charles Mercy Hospital
Oregon, Ohio, United States, 43616
St. Luke's Hospital
Maumee, Ohio, United States, 43537
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States, 44309-2090
Aultman Cancer Center at Aultman Hospital
Canton, Ohio, United States, 44710-1799
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States, 43623
Toledo Hospital
Toledo, Ohio, United States, 43606
United States Air Force Medical Center - Wright-Patterson
Wright-Patterson Afb, Ohio, United States, 45433-5529
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
Wood County Oncology Center
Bowling Green, Ohio, United States, 43402
United States, Oklahoma
Cancer Care Associates - Mercy Campus
Oklahoma City, Oklahoma, United States, 73120
Cleo Craig Cancer Research Clinic
Lawton, Oklahoma, United States, 73505
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
Cancer Center of Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301-1792
CCOP - Main Line Health
Wynnewood, Pennsylvania, United States, 19096
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States, 17822-0001
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, United States, 16801
Guthrie Cancer Center at Guthrie Clinic Sayre
Sayre, Pennsylvania, United States, 18840
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
Lewistown Hospital
Lewistown, Pennsylvania, United States, 17044
Cancer Center at Phoenixville Hospital
Phoenixville, Pennsylvania, United States, 19460
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Pottstown Memorial Regional Cancer Center
Pottstown, Pennsylvania, United States, 19464
St. Luke's Cancer Network at St. Luke's Hospital
Bethlehem, Pennsylvania, United States, 18015
United States, Texas
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
United States, Vermont
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States, 05401
Mountainview Medical
Berlin, Vermont, United States, 05602
United States, Wisconsin
All Saints Cancer Center at Wheaton Franciscan Healthcare
Racine, Wisconsin, United States, 53405
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Central Wisconsin Cancer Program at Agnesian HealthCare
Fond du Lac, Wisconsin, United States, 54935
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54301-3526
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Oncology Alliance, SC - Milwaukee - East
Glendale, Wisconsin, United States, 53212-1038
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
Wausau, Wisconsin, United States, 54401
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
United States, Wyoming
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States, 82801
Canada, Alberta
Lethbridge Cancer Centre
Lethbridge, Alberta, Canada, T1J 1W5
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
BCCA - Fraser Valley Cancer Centre
Surrey, British Columbia, Canada, V3V 1Z2
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
British Columbia Cancer Agency - Vancouver Island Centre
Victoria, British Columbia, Canada, V8R 6V5
Penticton Regional Hospital
Penticton, British Columbia, Canada, V2A 3G6
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, Canada, E1C 8X3
Moncton Hospital
Moncton, New Brunswick, Canada, E1C 6Z8
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
Doctor H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada, AIB 3V6
Canada, Ontario
Algoma District Cancer Program at Sault Area Hospital
Sault Ste. Marie, Ontario, Canada, P6A 2C4
Belleville General Hospital
Belleville, Ontario, Canada, K8N 5A9
Cambridge Memorial Hospital
Cambridge, Ontario, Canada, N1R 3G2
Edmond Odette Cancer Centre at Sunnybrook
Toronto, Ontario, Canada, M4N 3M5
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada, K7L 5P9
Carlo Fidani Peel Regional Cancer Centre at Credit Valley Hospital
Mississauga, Ontario, Canada, L5M 2N1
Cancer Care Program at Thunder Bay Regional Health Sciences
Thunder Bay, Ontario, Canada, P7B 6V4
Grand River Regional Cancer Centre at Grand River Hospital
Kitchener, Ontario, Canada, N2G 1G3
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Mount Sinai Hospital - Toronto
Toronto, Ontario, Canada, M5G 1X5
Northeastern Ontario Regional Cancer Centre
Sudbury, Ontario, Canada, P3E 5J1
St. Michael's Hospital - Toronto
Toronto, Ontario, Canada, M5B 1W8
R. S. McLaughlin Durham Regional Cancer Centre at Lakeridge Health Oshawa
Oshawa, Ontario, Canada, L1G 2B9
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y 2P9
St. Catharines General Hospital at Niagara Health System
St. Catharines, Ontario, Canada, L2R 7C6
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Trillium Health Centre - Mississauga Site
Mississauga, Ontario, Canada, L5B 1B8
Windsor Regional Cancer Centre at Windsor Regional Hospital
Windsor, Ontario, Canada, N8W 2X3
Canada, Prince Edward Island
Prince Edward Island Cancer Centre at Queen Elizabeth Hospital
Charlottetown, Prince Edward Island, Canada, C1A 8T5
Canada, Quebec
CHUS-Hopital Fleurimont
Sherbrooke, Quebec, Canada, J1H 5N4
Hopital Charles Lemoyne
Greenfield Park, Quebec, Canada, J4V 2H1
Hopital du Saint-Sacrement - Quebec
Quebec City, Quebec, Canada, G1S 4L8
Hopital Notre-Dame du CHUM
Montreal, Quebec, Canada, H2L 4M1
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
NCIC Clinical Trials Group
North Central Cancer Treatment Group
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
Southwest Oncology Group
International Breast Cancer Study Group
Investigators
Study Chair: Paul E. Goss, MD, PhD Massachusetts General Hospital
Study Chair: James N. Ingle, MD Mayo Clinic
Study Chair: Matthew J. Ellis, MD, PhD, FRCP Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Study Chair: George W. Sledge, MD Indiana University Melvin and Bren Simon Cancer Center
Study Chair: George T. Budd, MD The Cleveland Clinic
Principal Investigator: Manuela Rabaglio, MD University Hospital Inselspital, Berne
  More Information

Additional Information:
Publications:
Moy B, Elliott CR, Chapman J-AW, et al.: NCIC CTG MA.27: menopausal symptoms of ethnic minority women. [Abstract] Breast Cancer Res Treat 100 (Suppl 1): A-3059, S144, 2006.

Responsible Party: Cancer Research Institute at Queen's University ( Joseph L. Pater )
Study ID Numbers: CDR0000316325, CAN-NCIC-MA27 (COMPANION), NCCTG-MA27, CALGB-CAN-NCIC-MA27, ECOG-CAN-NCIC-MA27, SWOG-CAN-NCIC-MA27, IBCSG-30-04, EUDRACT-2005-001893-28
Study First Received: August 6, 2003
Last Updated: May 28, 2009
ClinicalTrials.gov Identifier: NCT00066573     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IIIA breast cancer
stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Anastrozole
Antineoplastic Agents, Hormonal
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Breast Neoplasms
Enzyme Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Exemestane
Aromatase Inhibitors
Breast Diseases

ClinicalTrials.gov processed this record on November 22, 2009