At a glance
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An Open Phase III Trial With Letrozole Alone or in Combination With Zoledronic Acid as Extended Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer
In Brief
A Phase 3 clinical trial evaluating Letrozole and Zoledronic acid for Osteoporosis and Postmenopausal. Completed, enrolled 83 participants across 23 sites.
Detailed 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 breast cancer who had received 4 to 6 years of adjuvant tamoxifen therapy after resection of the tumor. Patients were treated with letrozole 2.5 mg orally per day or letrozole 2.5 mg orally per day in combination with zoledronic acid 4 mg/6 months as an infusion. This trial did not recruit patients in the United States.
Study Details
Timeline
Interventions
2.5 mg/day for 3 years
4 mg every 6 months