Rheumatological Evaluation of Anastrozole and Letrozole as Adjuvant Treatment in Post-menopausal Women With Breast Cancer
REAL
Open-label, Single-arm, Multicenter Study to Evaluate the Rheumatological Tolerability of Letrozole as an Adjuvant Breast Cancer Treatment in Postmenopausal Women Who Are Intolerant and Discontinue Anastrozole Due to Grade 2-3 Arthralgia-myalgia
1 other identifier
interventional
261
1 country
48
Brief Summary
This study will evaluate whether patients who are intolerant and discontinue anastrozole due to grade 2-3 arthralgia-myalgia have a decrease in rheumatological symptoms while taking letrozole
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 breast-cancer
Started Mar 2008
Shorter than P25 for phase_4 breast-cancer
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 29, 2008
CompletedFirst Posted
Study publicly available on registry
June 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
May 24, 2021
CompletedJune 9, 2021
May 1, 2021
1.3 years
May 29, 2008
April 29, 2021
May 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Discontinuing Due to Grade 2 or Higher Arthralgia-myalgia.
The arthralgia status and the myalgia status were separately graded at Baseline (V1), Week 12 (V3) , and Week 24/EOS (V4). The grades of 0 for no pain, 1 for mild pain, 2 for moderate pain, 3 for severe pain, and 4 for disabling pain were used.
End of Study (24 weeks)
Secondary Outcomes (5)
Time to Discontinuation Due to Grade 2 or Higher Arthralgia- Myalgia.
End of Study (24 weeks)
Percentage of Participants Discontinuing, Irrespective of Cause
End of Study (24 weeks)
Change in Brief Pain Inventory (BPI) Composite Score
Baseline, 24 weeks (End of Study)
Change in Disability Index as Assessed by Health Assessment Questionnaire (HAQ)
Baseline, Visit 1(24 weeks = End of Study)
Change in Pain as Assessed by Visual Analog Scale (VAS) Scale of the Health Assessment Questionnaire (HAQ)
Baseline, Visit 1 (24 weeks = End of Study)
Study Arms (1)
Letrozole
EXPERIMENTALParticipants received 2.5 milligram (mg) of Letrozole tablets orally once daily (QD) for a period of 24 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Postmenopausal women with HR+ early stage breast cancer at the time of initial diagnosis. For study purposes, postmenopausal is defined as:
- 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.
- 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.
- Hormone receptor-positive tumors as defined by institutional standards.
- ECOG performance status of 0, 1, or 2
- Consent to participate in the trial. -
You may not qualify if:
- Postmenopausal women with HR+ metastatic or locally relapsed breast cancer excluding chest wall recurrence with no evidence of systemic disease.
- Recent history of pain associated with non-traumatic bone fracture.
- Pain requiring chronic use of analgesics (due to any reason).
- History of rheumatological disease except osteoarthritis.
- Prior hormonal therapy with AIs other than anastrozole.
- Systemic hormone replacement therapy (HRT) less than 4 weeks before study entry other than Estring®, Vagifem® or low dose estrogen vaginal cream.
- Concomitant disease which significantly affects quality of life.
- Patient unable to complete self administered questionnaire.
- Patients unable to sign consent form.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Clearview Cancer Center
Huntsville, Alabama, 35805, United States
Hematology Oncology Services of Arkansas
Little Rock, Arkansas, 72205, United States
Grass Valley Hematology Oncology
Grass Valley, California, 95945, United States
Aptium Oncology - Comprehensive Cancer Care of the Desert
Palm Springs, California, 92262, United States
Bay Area Cancer Research Group
Pleasant Hill, California, 94523, United States
Front Range Specialist
Fort Collins, Colorado, 80528, United States
Lynn Cancer Center
Boca Raton, Florida, 33428, United States
Florida Cancer Specialists
Fort Myers, Florida, 33916, United States
Memorial Cancer Center
Hollywood, Florida, 33021, United States
Palm Beach Cancer Specialists
West Palm Beach, Florida, 33401, United States
Northeast Georgia Cancer Care, LLC
Athens, Georgia, 30607, United States
Augusta Oncology
Augusta, Georgia, 30901, United States
Oncology Specialist of North Georgia
Gainesville, Georgia, 30501, United States
The Cancer Instiute at Alexian Brothers
Elk Grove Village, Illinois, 60007, United States
Evanston Northwestern Hospital
Evanston, Illinois, 60201, United States
Edward H. Kaplan MD & Associates - North Shore Cancer Research Associates
Skokie, Illinois, 60076, United States
Cancer Care of Kansas
Wichita, Kansas, 67214, United States
Kentuckiana Cancer Institute
Louisville, Kentucky, 40202, United States
Mercy Hospital
Portland, Maine, 04101, United States
Mercey Hospital
Baltimore, Maryland, 21202, United States
Maryland Hematology Oncology Associates, PA
Baltimore, Maryland, 21237, United States
Suburban Hospital Cancer Program
Bethesda, Maryland, 20817, United States
Hematology Oncology Asssociates of Ohio & Michigan
Lambertville, Michigan, 48144, United States
Center for Cancer Care and Research
St Louis, Missouri, 63141, United States
Ballas Cancer Center, LLC DBA - St Louis
St Louis, Missouri, 63414, United States
Southeast Nebraska Hematology & Oncology Consultants
Lincoln, Nebraska, 68516, United States
Trinitas Comprehensive Cancer Center
Elizabeth, New Jersey, 07207, United States
Hematology-Oncology Assoc of Northern New Jersey
Morristown, New Jersey, 07962, United States
Somerset Hematology & Oncology
Somerville, New Jersey, 08876, United States
Cooper University Hospital
Voorhees Township, New Jersey, 08043, United States
Broom Oncology
Binghamton, New York, 13905, United States
Cancer Care of W. NC
Asheville, North Carolina, 28801, United States
Marion L. Shepard Cancer Center
Washington, North Carolina, 27889, United States
Summa Health System
Akron, Ohio, 44304, United States
Mukesh Bhatt, MD, INC.
Medina, Ohio, 44256, United States
Berks Hematology Oncology
West Reading, Pennsylvania, 19611, United States
South Carolina Oncology Associates
Columbia, South Carolina, 29210, United States
The West Clinic
Memphis, Tennessee, 38138, United States
Tenessee Oncology
Nashville, Tennessee, 37203, United States
Coastal Bend Cancer Center
Corpus Christi, Texas, 78404, United States
Center for Oncology Research and Treatment
Dallas, Texas, 75230, United States
Central Utah Clinic
American Fork, Utah, 84003, United States
Northern Utah Associates
Ogden, Utah, 84403, United States
Medical Oncology & Hematology Associates of Northern Virginia
Fairfax, Virginia, 22031, United States
Rockingham Memorial Hospital Regional Cancer Center
Harrisonburg, Virginia, 22801, United States
Peninsula Cancer Center
Newport News, Virginia, 23601, United States
Green Bay Oncologist, St Vincent Hospital
Green Bay, Wisconsin, 54301, United States
Oncology Alliance
Wauwatosa, Wisconsin, 53226, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2008
First Posted
June 3, 2008
Study Start
March 1, 2008
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
June 9, 2021
Results First Posted
May 24, 2021
Record last verified: 2021-05