Rheumatological Evaluation of Anastrozole and Letrozole as Adjuvant Treatment in Post-menopausal Women With Breast Cancer

Completed · Phase 4

Conditions studied: Breast Cancer

In brief

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

Key facts

Study ID

NCT00688909

Run by

Novartis Pharmaceuticals

People needed

261

Starts

2008-03-01

Expected to finish

2009-06-01

Last updated by the study team

2021-06-09

Who can join

Age: 50 and older. Sex: female. Healthy volunteers: not accepted.

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.
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• 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

Full record on ClinicalTrials.gov

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