ABCSG 18 ZA Overview

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study to Determine the Treatment Effect of Denosumab in Subjects With Non-Metastatic Breast Cancer Receiving Aromatase Inhibitor Therapy/ Zoledronic Acid (ZA) Substudy

ABCSG 18 ZA was developed as an additional protocol to assess the effects of a single intravenous ZA administration on bone density, fracture incidence, and bone turnover markers (CTX and osteocalcin) in a subset of ABCSG 18 patients

Start: 02/2020
Coordinating Investigator: Michael Gnant; Vienna
Sample size: ABCSG 18: 3400 (Austria + Sweden);
ABCSG 18 ZA: planned in a subset of patients