NCT00332709

Safety/Efficacy of Letrozole Monotherapy or in Combination With Zoledronic Acid as Extended Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoporosis
• Postmenopausal

Interventions

Type	Name	Description
DRUG	Letrozole	2.5 mg/day for 3 years
DRUG	Zoledronic acid	4 mg every 6 months

Timeline

• Start date: 2006-01-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2006-06-02
• Last updated: 2011-11-16
• Results posted: 2011-11-16

Locations

23 sites across 1 country: Germany