Status:
COMPLETED
Safety/Efficacy of Letrozole Monotherapy or in Combination With Zoledronic Acid as Extended Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer
Lead Sponsor:
Novartis
Conditions:
Osteoporosis
Postmenopausal
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This was a prospective, randomized, open-label, two arm phase III trial designed to evaluate the efficacy and safety of zoledronic acid in preventing bone loss in postmenopausal women with operable br...
Eligibility Criteria
Inclusion
- Compliant postmenopausal women with primary operable breast cancer after 4 to 6 years of therapy with tamoxifen (end of tamoxifen therapy within last 6 months)
- Performance status 0-2 (Eastern Cooperative Oncology Group)
- Patients without severe osteoporosis at study entry
- No evidence of relapse at the time of randomization
- Adequate function of bone marrow, kidney, and liver
Exclusion
- Estrogen- and progesterone-receptor status negative or unknown
- Completion of adjuvant tamoxifen therapy more than 6 months prior to study start
- Inflammatory breast cancer
- Current/active dental problems including infection of the teeth or jawbone, dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw, of exposed bone in the mouth, or of slow healing after dental procedures.
- Recent (within 6 weeks) or planned dental or jaw surgery
- History of diseases with influence on bone metabolism such as Paget's disease and primary overactive parathyroid
- Prior or concomitant therapies: chemotherapy within the last 12 months, intravenous or oral bisphosphonates, systemic corticosteroids, anabolic steroids or growth hormones, Tibolone, parathyroid hormone, systemic sodium fluoride or any drugs known to affect the skeleton (such as calcitonin, mithramycin, or gallium nitrate)
- Patients with previous or concomitant cancers (not breast cancer) within the past 5 years EXCEPT adequately treated basal or squamous cell skin cancers or in situ cancer of the cervix. Patients with previous other cancer(s) must have been disease-free for at least 5 years.
- Patients currently receiving oral bisphosphonates must discontinue these at least 3 weeks prior to study start.
- Additional protocol defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00332709
Start Date
January 1 2006
End Date
August 1 2010
Last Update
November 16 2011
Active Locations (23)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Cologne, Germany
2
Novartis Investigative Site
Deggendorf, Germany
3
Novartis Investigative Site
Frankfurt am Main, Germany
4
Novartis Investigative Site
Freiburg im Breisgau, Germany