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

Information source: NSABP Foundation Inc
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: exemestane (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: NSABP Foundation Inc

Official(s) and/or principal investigator(s):
Norman Wolmark, MD, Principal Investigator, Affiliation: NSABP Foundation Inc

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.

Clinical Details

Official title: 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

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

Primary outcome: Disease-free survival

Secondary outcome:

Overall survival

Time to treatment failure

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

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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

Locations and Contacts

MBCCOP - San Juan, San Juan 00927-5800, Puerto Rico

Comprehensive Cancer Institute of Huntsville, Huntsville, Alabama 35801, United States

Tom Baker Cancer Center - Calgary, Calgary, Alberta T2N 4N2, Canada

Cross Cancer Institute, Edmonton, Alberta T6G 1Z2, Canada

CCOP - Greater Phoenix, Phoenix, Arizona 85006-2726, United States

University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States

British Columbia Cancer Agency, Vancouver, British Columbia V5Z 4E6, Canada

City of Hope Comprehensive Cancer Center, Duarte, California 91010-3000, United States

California Cancer Center, Fresno, California 93720, United States

Sutter Health Western Division Cancer Research Group, Greenbrae, California 94904, United States

Rebecca and John Moores UCSD Cancer Center, La Jolla, California 92093-0658, United States

Scripps Cancer Center, La Jolla, California 92037, United States

Loma Linda University Cancer Institute, Loma Linda, California 92354, United States

Pacific Shores Medical Group, Long Beach, California 90813, United States

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California 90095-1781, United States

Chao Family Comprehensive Cancer Center, Orange, California 92868, United States

Comprehensive Cancer Centers of the Desert, Palm Springs, California 92262, United States

Sutter Cancer Center, Sacramento, California 95816, United States

Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego, San Diego, California 92120, United States

CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California 95403, United States

Stanford University Medical Center, Stanford, California 94305-5408, United States

Kaiser Permanente Medical Center - Vallejo, Vallejo, California 94589, United States

CCOP - Colorado Cancer Research Program, Incorporated, Denver, Colorado 80224, United States

University of Colorado Cancer Center, Denver, Colorado 80010, United States

University of Connecticut, Farmington, Connecticut 06032, United States

Hartford Hospital, Hartford, Connecticut 06102-5037, United States

CCOP - Christiana Care Health Services, Newark, Delaware 19899, United States

George Washington University Medical Center, Washington, District of Columbia 20037, United States

Morton Plant Hospital, Clearwater, Florida 33756, United States

Halifax Medical Center, Daytona Beach, Florida 32114, United States

Baptist Regional Cancer Institute - Jacksonville, Jacksonville, Florida 32207, United States

CCOP - Mount Sinai Medical Center, Miami Beach, Florida 33140, United States

Sylvester Cancer Center, University of Miami, Miami, Florida 33136, United States

MD Anderson Cancer Center Orlando, Orlando, Florida 32806, United States

Cancer Research Network Inc., Plantation, Florida 33324, United States

Oncology Hematology Consultants, Sarasota, Florida 34239, United States

Emory University School of Medicine, Atlanta, Georgia 30322, United States

Medical College of Georgia, Augusta, Georgia 30912, United States

Dwight David Eisenhower Army Medical Center, Fort Gordon, Georgia 30905-5650, United States

Cancer Center of Hawaii, Honolulu, Hawaii 96826, United States

North Idaho Cancer Center, Coeur d'Alene, Idaho 83814, United States

Illinois Oncology, Ltd., Belleville, Illinois 62221, United States

Illinois Masonic Medical Center, Chicago, Illinois 60657, United States

Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois 60612, United States

CCOP - Central Illinois, Decatur, Illinois 62526, United States

Alexian Brothers Medical Center, Elk Grove Village, Illinois 60007, United States

CCOP - Evanston, Evanston, Illinois 60201, United States

West Suburban Hospital Medical Center, Oak Park, Illinois 60302, United States

CCOP - Illinois Oncology Research Association, Peoria, Illinois 61602, United States

CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States

Clarian Health Partners Inc., Indianapolis, Indiana 46206-1367, United States

St. Vincent Hospital and Health Care Center, Indianapolis, Indiana 46260, United States

CCOP - Northern Indiana CR Consortium, South Bend, Indiana 46601, United States

Genesis Medical Center, Davenport, Iowa 52803, United States

CCOP - Iowa Oncology Research Association, Des Moines, Iowa 50309-1016, United States

Holden Comprehensive Cancer Center, Iowa City, Iowa 52242-1009, United States

CCOP - Wichita, Wichita, Kansas 67214-3882, United States

Lucille Parker Markey Cancer Center, University of Kentucky, Lexington, Kentucky 43213, United States

Consultants in Blood Disorders and Cancer, Louisville, Kentucky 40207, United States

Norton Healthcare System, Louisville, Kentucky 40202-5070, United States

CCOP - Ochsner, New Orleans, Louisiana 70121, United States

Louisiana State University Medical Center - New Orleans, New Orleans, Louisiana 70112, United States

Tulane University Medical Center, New Orleans, Louisiana 70112, United States

Eastern Maine Medical Center, Bangor, Maine 04401, United States

Franklin Square Hospital Center, Baltimore, Maryland 21237, United States

National Naval Medical Center, Bethesda, Maryland 20889-5000, United States

Boston Medical Center, Boston, Massachusetts 02118, United States

Lahey Clinic - Burlington, Burlington, Massachusetts 01805, United States

Berkshire Medical Center, Pittsfield, Massachusetts 01201, United States

Baystate Medical Center, Springfield, Massachusetts 01199, United States

CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan 48106, United States

Henry Ford Health System, Detroit, Michigan 48202, United States

Michigan State University, East Lansing, Michigan 48824, United States

CCOP - Grand Rapids, Grand Rapids, Michigan 49503, United States

CCOP - Kalamazoo, Kalamazoo, Michigan 49007-3731, United States

William Beaumont Hospital, Royal Oak, Michigan 48073, United States

Providence Hospital - Southfield, Southfield, Michigan 48075-9975, United States

CCOP - Duluth, Duluth, Minnesota 55805, United States

Abbott-Northwestern Hospital, Minneapolis, Minnesota 55415, United States

CCOP - Metro-Minnesota, Saint Louis Park, Minnesota 55416, United States

Ellis Fischel Cancer Center - Columbia, Columbia, Missouri 65203, United States

CCOP - Kansas City, Kansas City, Missouri 64131, United States

CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri 63141, United States

St. Louis University Health Sciences Center, Saint Louis, Missouri 63110-0250, United States

CCOP - Cancer Research for the Ozarks, Springfield, Missouri 65807, United States

CCOP - Montana Cancer Consortium, Billings, Montana 59101, United States

CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska 68106, United States

Methodist Hospital Cancer Center - Omaha, Omaha, Nebraska 68114, United States

CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada 89106, United States

CCOP - Northern New Jersey, Hackensack, New Jersey 07601, United States

Cancer Institute of New Jersey, New Brunswick, New Jersey 08903, United States

Newark Beth Israel Medical Center, Newark, New Jersey 07112, United States

MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico 87131, United States

New York Oncology Hematology, P.C., Albany, New York 12208, United States

Lincoln Medical and Mental Health Center, Bronx, New York 10451, United States

MBCCOP-Our Lady of Mercy Cancer Center, Bronx, New York 10466, United States

Glens Falls Hospital, Glens Falls, New York 12801, United States

Staten Island University Hospital, Staten Island, New York 10305, United States

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse, New York 13217, United States

Alamance Cancer Center, Burlington, North Carolina 27216, United States

Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina 27599-7295, United States

East Carolina University School of Medicine, Greenville, North Carolina 27858-4354, United States

CCOP - Southeast Cancer Control Consortium, Winston-Salem, North Carolina 27104-4241, United States

Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina 27157-1082, United States

CCOP - Merit Care Hospital, Fargo, North Dakota 58122, United States

Akron City Hospital, Akron, Ohio 44309, United States

Aultman Cancer Center, Canton, Ohio 44710, United States

Barrett Cancer Center, Cincinnati, Ohio 45267-0502, United States

Jewish Hospital of Cincinnati, Inc., Cincinnati, Ohio 45236, United States

Ireland Cancer Center, Cleveland, Ohio 44106-5065, United States

Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio 43210-1240, United States

CCOP - Columbus, Columbus, Ohio 43206, United States

CCOP - Dayton, Kettering, Ohio 45429, United States

CCOP - Toledo Community Hospital, Toledo, Ohio 43623-3456, United States

South Pointe Hospital - Cancer Care Center, Warrensville Heights, Ohio 44122, United States

CCOP - Oklahoma, Tulsa, Oklahoma 74136, United States

Credit Valley Hospital, Mississauga, Ontario L5M 2N1, Canada

Toronto Sunnybrook Regional Cancer Centre, Toronto, Ontario, Canada

CCOP - Columbia River Oncology Program, Portland, Oregon 97213, United States

Lehigh Valley Hospital, Allentown, Pennsylvania 18103, United States

Geisinger Medical Center, Danville, Pennsylvania 17822-2001, United States

Albert Einstein Cancer Center, Philadelphia, Pennsylvania 19141, United States

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania 19107-5541, United States

Allegheny General Hospital, Pittsburgh, Pennsylvania 15212-4772, United States

University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania 15213-3489, United States

Reading Hospital and Medical Center, Reading, Pennsylvania 19612-6052, United States

Mercy Hospital Cancer Center - Scranton, Scranton, Pennsylvania 18501, United States

CCOP - MainLine Health, Wynnewood, Pennsylvania 19096, United States

York Cancer Center, York, Pennsylvania 17315, United States

Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec H2L-4M1, Canada

Jewish General Hospital - Montreal, Montreal, Quebec H3T 1E2, Canada

Montreal General Hospital, Montreal, Quebec H3G 1A4, Canada

Royal Victoria Hospital - Montreal, Montreal, Quebec H3A 1A1, Canada

St. Mary's Hospital Center, Montreal, Quebec H3T 1M5, Canada

Hopital du Saint-Sacrement, Quebec, Quebec City, Quebec G1S 4L8, Canada

CCOP - Greenville, Greenville, South Carolina 29615, United States

CCOP - Upstate Carolina, Spartanburg, South Carolina 29303, United States

CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota 57104, United States

Thompson Cancer Survival Center, Knoxville, Tennessee 37916, United States

Center for Oncology Research and Treatment, Medical City Hospital, Dallas, Texas 75230, United States

Simmons Cancer Center - Dallas, Dallas, Texas 75235-9154, United States

Baylor College of Medicine, Houston, Texas 77030, United States

Joe Arrington Cancer Research and Treatment Center, Lubbock, Texas 79410-1894, United States

University of Texas Health Science Center at San Antonio, San Antonio, Texas 78284-7811, United States

CCOP - Scott and White Hospital, Temple, Texas 76508, United States

Utah Valley Regional Medical Center - Provo, Provo, Utah 84604, United States

Huntsman Cancer Institute, Salt Lake City, Utah 84112, United States

Green Mountain Oncology Group, Bennington, Vermont 05201, United States

Vermont Cancer Center, Burlington, Vermont 05405-0075, United States

Virginia Oncology Associates - Newport News, Newport News, Virginia 23606, United States

Eastern Virginia Medical School, Norfolk, Virginia 23507, United States

Massey Cancer Center, Richmond, Virginia 23298-0037, United States

Oncology and Hematology Associates of Southwest Virginia, Inc., Roanoke, Virginia 24014, United States

CCOP - Virginia Mason Research Center, Seattle, Washington 98101, United States

Puget Sound Oncology Consortium, Seattle, Washington 98109, United States

CCOP - Northwest, Tacoma, Washington 98405-0986, United States

Camcare Health, Charleston, West Virginia 25304, United States

Camden-Clark Memorial Hospital, Parkersburg, West Virginia 26102, United States

St. Vincent Hospital, Green Bay, Wisconsin 54307-3508, United States

CCOP - Marshfield Medical Research and Education Foundation, Marshfield, Wisconsin 54449, United States

Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin 53226, United States

St. Luke's Medical Center, Milwaukee, Wisconsin 53215, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: May 2001
Last updated: April 18, 2011

Page last updated: August 20, 2015

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