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
This is a multi-center prospective non-randomized single arm, open label trial in
postmenopausal HR positive early breast cancer patients who experience grade 2-3
arthralgia-myalgia while on anastrozole, resulting in the discontinuation of anastrozole.
After a 2-3 week period without any aromatase inhibitor treatment, eligible patients will
initiate letrozole treatment at a dose of 2.5mg per day for a duration of 24 weeks. If a
patient has breast cancer recurrence or is intolerant to letrozole during the 24 week
period, the drug will be discontinued.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Proportion of patients discontinuing due to grade 2 or higher arthralgia-myalgia.
6 months
Yes
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CFEM345DUS59
NCT00688909
March 2008
June 2009
Name | Location |
---|---|
Cooper University Hospital | Camden, New Jersey 08103 |
Summa Health System | Akron, Ohio 44312 |
Florida Cancer Specialists | Fort Myers, Florida 33901 |
Center for Cancer Care and Research | St. Louis, Missouri 63141 |
South Carolina Oncology Associates | Columbia, South Carolina 29201 |
Kentuckiana Cancer Institute | Louisville, Kentucky 40202 |
Hematology Oncology Services of Arkansas | Little Rock, Arkansas 72205 |
Suburban Hospital Cancer Program | Bethesda, Maryland 20817 |
Center for Oncology Research and Treatment | Dallas, Texas 75230 |
Northern Utah Associates | Ogden, Utah 84403 |
Northeast Georgia Cancer Care, LLC | Athens, Georgia 30607 |
Bay Area Cancer Research Group | Concord, California 94520 |
The West Clinic | Memphis, Tennessee 38120 |
Mercy Hospital | Portland, Maine 04101 |
Coastal Bend Cancer Center | Corpus Christi, Texas 78404 |
Oncology Alliance | Milwaukee, Wisconsin 53215 |
Cancer Care of Kansas | Wichita, Kansas 67214 |
Marion L. Shepard Cancer Center | Washington, North Carolina |
Peninsula Cancer Center | Newport News, Virginia 23601 |
Clearview Cancer Center | Huntsville, Alabama 35801 |
Trinitas Comprehensive Cancer Center | Elizabeth, New Jersey 07207 |
Somerset Hematology & Oncology | Somerville, New Jersey 08876 |
Central Utah Clinic | Provo, Utah 84003 |
Rockingham Memorial Hospital Regional Cancer Center | Harrisonburg, Virginia 22801 |
Medical Oncology & Hematology Associates of Northern Virginia | Fairfax, Virginia 22031 |
Grass Valley Hematology Oncology | Grass Valley, California 95945 |
Aptium Oncology - Comprehensive Cancer Care of the Desert | Palm Springs, California 92262 |
Front Range Specialist | Fort Collins, Colorado 80528 |
Lynn Cancer Center | Boca Raton, Florida 33428 |
Memorial Cancer Center | Hollywood, Florida 33021 |
Palm Beach Cancer Specialists | West Palm Beach, Florida 33401 |
Augusta Oncology | Augusta, Georgia 30901 |
Oncology Specialist of North Georgia | Gainesville, Georgia 30501 |
The Cancer Instiute at Alexian Brothers | Elk Grove Village, Illinois 60007 |
Evanston Northwestern Hospital | Evanston, Illinois 60201 |
Edward H. Kaplan MD & Associates - North Shore Cancer Research Associates | Skokie, Illinois 60076 |
Maryland Hematology Oncology Associates, PA | Baltimore, Maryland 21237 |
Mercey Hospital | Baltimore, Maryland 21202 |
Hematology Oncology Asssociates of Ohio & Michigan | Lambertville, Michigan 48144 |
Ballas Cancer Center, LLC DBA - St Louis | St. Louis, Missouri 63414 |
Southeast Nebraska Hematology & Oncology Consultants | Lincoln, Nebraska 68516 |
Hematology-Oncology Assoc of Northern New Jersey | Morristown, New Jersey 07962 |
Broom Oncology | Binghamton, New York 13905 |
Cancer Care of W. NC | Ashville, North Carolina 28801 |
Mukesh Bhatt, MD, INC. | Medina, Ohio 44256 |
Berks Hematology Oncology | West Reading, Pennsylvania 19611 |
Tenessee Oncology | Nashville, Tennessee 37203 |
Green Bay Oncologist, St Vincent Hospital | Green Bay, Wisconsin 54301 |