Everolimus as treatment for breast cancer patients with bone metastases only: results of the phase II RADAR study.

ABSTRACT:

Purpose

Everolimus has shown to stop formation and activity of osteoclasts. Breast cancer patients with bone metastases only are candidates for effective but low toxic treatment.

Patients and methods

We evaluated everolimus in a double-blind, placebo-controlled, phase II, randomized discontinuation study in breast cancer patients with HER2 negative breast cancer patients with bone metastases only. After being stable on 8 weeks of everolimus 10 mg/day, patients were randomized to everolimus-continuation or placebo. Primary outcome was time (from randomization) to progression (TTP). Seventy-six patients would have had to be randomized to show a hazard ration (HR) of 0.5 for everolimus-continuation.

Results

Eighty-nine patients were enrolled in 4 years. Thirty-nine patie

SUBMITTER: Maass N 

PROVIDER: S-EPMC11824442 | biostudies-literature | 2013 Dec

REPOSITORIES: biostudies-literature