Status:
COMPLETED
Rheumatological Evaluation of Anastrozole and Letrozole as Adjuvant Treatment in Post-menopausal Women With Breast Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Breast Cancer
Eligibility:
FEMALE
50+ years
Phase:
PHASE4
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
Detailed Description
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 anastrozo...
Eligibility Criteria
Inclusion
- 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. -
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
261 Patients enrolled
Trial Details
Trial ID
NCT00688909
Start Date
March 1 2008
End Date
June 1 2009
Last Update
June 9 2021
Active Locations (48)
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1
Clearview Cancer Center
Huntsville, Alabama, United States, 35805
2
Hematology Oncology Services of Arkansas
Little Rock, Arkansas, United States, 72205
3
Grass Valley Hematology Oncology
Grass Valley, California, United States, 95945
4
Aptium Oncology - Comprehensive Cancer Care of the Desert
Palm Springs, California, United States, 92262