Rheumatological Evaluation of Anastrozole and Letrozole as Adjuvant Treatment in Post-menopausal Women With Breast Cancer
NCT ID: NCT00688909
Last Updated: 2021-06-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
261 participants
INTERVENTIONAL
2008-03-31
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Letrozole
Participants received 2.5 milligram (mg) of Letrozole tablets orally once daily (QD) for a period of 24 weeks.
letrozole
2.5 mg daily by mouth for 6 months
Interventions
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letrozole
2.5 mg daily by mouth for 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥ 50 y and amenorrheic for 12 or more months.
* Age ≥ 50 y and amenorrheic for 3 or more months after receiving adjuvant chemotherapy.
* Age \< 50 y and amenorrheic for 12 or more months.
* Prior bilateral oophorectomy.
* Prior hysterectomy and has postmenopausal levels of FSH, LH, and estradiol as per local institutional standards.
* Age \> 55 y and prior hysterectomy.
2. Patients who are intolerant and discontinue anastrozole 2-3 weeks prior to study entry when given as adjuvant treatment for HR+ early stage breast cancer due to grade 2-3 (NCI-CTCAE V3) arthralgia-myalgia.
3. Hormone receptor-positive tumors as defined by institutional standards.
4. ECOG performance status of 0, 1, or 2
5. Consent to participate in the trial. -
Exclusion Criteria
2. Recent history of pain associated with non-traumatic bone fracture.
3. Pain requiring chronic use of analgesics (due to any reason).
4. History of rheumatological disease except osteoarthritis.
5. Prior hormonal therapy with AIs other than anastrozole.
6. Systemic hormone replacement therapy (HRT) less than 4 weeks before study entry other than Estring®, Vagifem® or low dose estrogen vaginal cream.
7. Concomitant disease which significantly affects quality of life.
8. Patient unable to complete self administered questionnaire.
9. Patients unable to sign consent form.
50 Years
FEMALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Clearview Cancer Center
Huntsville, Alabama, United States
Hematology Oncology Services of Arkansas
Little Rock, Arkansas, United States
Grass Valley Hematology Oncology
Grass Valley, California, United States
Aptium Oncology - Comprehensive Cancer Care of the Desert
Palm Springs, California, United States
Bay Area Cancer Research Group
Pleasant Hill, California, United States
Front Range Specialist
Fort Collins, Colorado, United States
Lynn Cancer Center
Boca Raton, Florida, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Memorial Cancer Center
Hollywood, Florida, United States
Palm Beach Cancer Specialists
West Palm Beach, Florida, United States
Northeast Georgia Cancer Care, LLC
Athens, Georgia, United States
Augusta Oncology
Augusta, Georgia, United States
Oncology Specialist of North Georgia
Gainesville, Georgia, United States
The Cancer Instiute at Alexian Brothers
Elk Grove Village, Illinois, United States
Evanston Northwestern Hospital
Evanston, Illinois, United States
Edward H. Kaplan MD & Associates - North Shore Cancer Research Associates
Skokie, Illinois, United States
Cancer Care of Kansas
Wichita, Kansas, United States
Kentuckiana Cancer Institute
Louisville, Kentucky, United States
Mercy Hospital
Portland, Maine, United States
Mercey Hospital
Baltimore, Maryland, United States
Maryland Hematology Oncology Associates, PA
Baltimore, Maryland, United States
Suburban Hospital Cancer Program
Bethesda, Maryland, United States
Hematology Oncology Asssociates of Ohio & Michigan
Lambertville, Michigan, United States
Center for Cancer Care and Research
St Louis, Missouri, United States
Ballas Cancer Center, LLC DBA - St Louis
St Louis, Missouri, United States
Southeast Nebraska Hematology & Oncology Consultants
Lincoln, Nebraska, United States
Trinitas Comprehensive Cancer Center
Elizabeth, New Jersey, United States
Hematology-Oncology Assoc of Northern New Jersey
Morristown, New Jersey, United States
Somerset Hematology & Oncology
Somerville, New Jersey, United States
Cooper University Hospital
Voorhees Township, New Jersey, United States
Broom Oncology
Binghamton, New York, United States
Cancer Care of W. NC
Asheville, North Carolina, United States
Marion L. Shepard Cancer Center
Washington, North Carolina, United States
Summa Health System
Akron, Ohio, United States
Mukesh Bhatt, MD, INC.
Medina, Ohio, United States
Berks Hematology Oncology
West Reading, Pennsylvania, United States
South Carolina Oncology Associates
Columbia, South Carolina, United States
The West Clinic
Memphis, Tennessee, United States
Tenessee Oncology
Nashville, Tennessee, United States
Coastal Bend Cancer Center
Corpus Christi, Texas, United States
Center for Oncology Research and Treatment
Dallas, Texas, United States
Central Utah Clinic
American Fork, Utah, United States
Northern Utah Associates
Ogden, Utah, United States
Medical Oncology & Hematology Associates of Northern Virginia
Fairfax, Virginia, United States
Rockingham Memorial Hospital Regional Cancer Center
Harrisonburg, Virginia, United States
Peninsula Cancer Center
Newport News, Virginia, United States
Green Bay Oncologist, St Vincent Hospital
Green Bay, Wisconsin, United States
Oncology Alliance
Wauwatosa, Wisconsin, United States
Countries
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Related Links
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Results for CFEM345DUS59 from the Novartis Clinical Trials Results Database
Other Identifiers
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CFEM345DUS59
Identifier Type: -
Identifier Source: org_study_id
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