Clinical trial NCT00688909: Rheumatological Evaluation of Anastrozole and Letrozole as Adjuvant Treatment in Post-menopausal Women With Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Keywords: breast cancer
adjuvant treatment in post menopausal women
letrozole
arthralgia-myalgia
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-06-03
Enrollment: 261
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 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.

Eligibility criteria: Inclusion Criteria:

1. 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.
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:

1. Postmenopausal women with HR+ metastatic or locally relapsed breast cancer excluding chest wall recurrence with no evidence of systemic disease.
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.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Number of Participants Discontinuing Due to Grade 2 or Higher Arthralgia-myalgia.
timeFrame: End of Study (24 weeks)
Secondary outcomes:
measure: Time to Discontinuation Due to Grade 2 or Higher Arthralgia- Myalgia.
timeFrame: End of Study (24 weeks)
measure: Percentage of Participants Discontinuing, Irrespective of Cause
timeFrame: End of Study (24 weeks)
measure: Change in Brief Pain Inventory (BPI) Composite Score
timeFrame: Baseline, 24 weeks (End of Study)
measure: Change in Disability Index as Assessed by Health Assessment Questionnaire (HAQ)
timeFrame: Baseline, Visit 1(24 weeks = End of Study)
measure: Change in Pain as Assessed by Visual Analog Scale (VAS) Scale of the Health Assessment Questionnaire (HAQ)
timeFrame: Baseline, Visit 1 (24 weeks = End of Study)
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Clearview Cancer Center
state: Alabama
city: Little Rock
country: United States
facility: Hematology Oncology Services of Arkansas
state: Arkansas
city: Grass Valley
country: United States
facility: Grass Valley Hematology Oncology
state: California
city: Palm Springs
country: United States
facility: Aptium Oncology - Comprehensive Cancer Care of the Desert
state: California
city: Pleasant Hill
country: United States
facility: Bay Area Cancer Research Group
state: California
city: Fort Collins
country: United States
facility: Front Range Specialist
state: Colorado
city: Boca Raton
country: United States
facility: Lynn Cancer Center
state: Florida
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Hollywood
country: United States
facility: Memorial Cancer Center
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Cancer Specialists
state: Florida
city: Athens
country: United States
facility: Northeast Georgia Cancer Care, LLC
state: Georgia
city: Augusta
country: United States
facility: Augusta Oncology
state: Georgia
city: Gainesville
country: United States
facility: Oncology Specialist of North Georgia
state: Georgia
city: Elk Grove Village
country: United States
facility: The Cancer Instiute at Alexian Brothers
state: Illinois
city: Evanston
country: United States
facility: Evanston Northwestern Hospital
state: Illinois
city: Skokie
country: United States
facility: Edward H. Kaplan MD & Associates - North Shore Cancer Research Associates
state: Illinois
city: Wichita
country: United States
facility: Cancer Care of Kansas
state: Kansas
city: Louisville
country: United States
facility: Kentuckiana Cancer Institute
state: Kentucky
city: Portland
country: United States
facility: Mercy Hospital
state: Maine
city: Baltimore
country: United States
facility: Mercey Hospital
state: Maryland
city: Baltimore
country: United States
facility: Maryland Hematology Oncology Associates, PA
state: Maryland
city: Bethesda
country: United States
facility: Suburban Hospital Cancer Program
state: Maryland
city: Lambertville
country: United States
facility: Hematology Oncology Asssociates of Ohio & Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Center for Cancer Care and Research
state: Missouri
city: Saint Louis
country: United States
facility: Ballas Cancer Center, LLC DBA - St Louis
state: Missouri
city: Lincoln
country: United States
facility: Southeast Nebraska Hematology & Oncology Consultants
state: Nebraska
city: Elizabeth
country: United States
facility: Trinitas Comprehensive Cancer Center
state: New Jersey
city: Morristown
country: United States
facility: Hematology-Oncology Assoc of Northern New Jersey
state: New Jersey
city: Somerville
country: United States
facility: Somerset Hematology & Oncology
state: New Jersey
city: Voorhees
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Binghamton
country: United States
facility: Broom Oncology
state: New York
city: Asheville
country: United States
facility: Cancer Care of W. NC
state: North Carolina
city: Washington
country: United States
facility: Marion L. Shepard Cancer Center
state: North Carolina
city: Akron
country: United States
facility: Summa Health System
state: Ohio
city: Medina
country: United States
facility: Mukesh Bhatt, MD, INC.
state: Ohio
city: West Reading
country: United States
facility: Berks Hematology Oncology
state: Pennsylvania
city: Columbia
country: United States
facility: South Carolina Oncology Associates
state: South Carolina
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
city: Nashville
country: United States
facility: Tenessee Oncology
state: Tennessee
city: Corpus Christi
country: United States
facility: Coastal Bend Cancer Center
state: Texas
city: Dallas
country: United States
facility: Center for Oncology Research and Treatment
state: Texas
city: American Fork
country: United States
facility: Central Utah Clinic
state: Utah
city: Ogden
country: United States
facility: Northern Utah Associates
state: Utah
city: Fairfax
country: United States
facility: Medical Oncology & Hematology Associates of Northern Virginia
state: Virginia
city: Harrisonburg
country: United States
facility: Rockingham Memorial Hospital Regional Cancer Center
state: Virginia
city: Newport News
country: United States
facility: Peninsula Cancer Center
state: Virginia
city: Green Bay
country: United States
facility: Green Bay Oncologist, St Vincent Hospital
state: Wisconsin
city: Wauwatosa
country: United States
facility: Oncology Alliance
state: Wisconsin
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: