Efficacy and Safety of Letrozole vs. Letrozole Plus Zoledronic Acid as Endocrine Therapy Before Surgery in Postmenopausal Patients With Breast Cancer

Phase 4 Terminated 168 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will evaluate the safety/efficacy of zoledronic acid when given by intravenous infusion every 4 weeks in addition to letrozole as endocrine therapy in postmenopausal patients with hormone responsive breast cancer

Timeline

Start: 2006-06-01
Primary completion: 2010-12-16
Completion: 2010-12-16

Outcome

Missed primary endpoint

registry Letrozole (LET) vs Letrozole + Zoledronic Acid (LET+ZOL); p = 0.106; Odds Ratio (OR) 14.7 (95% CI -1.8 to 31.1); Fisher Exact NCT00375752 ↗

Publications

Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Zoledronic acid	Other / unclassified	4 mg	Intravenous
Background	Letrozole	Other / unclassified	2.5 mg	Oral