Randomized, Double Blind Multicenter Phase II Study of Time to Progression on Fulvestrant in Combination With Erlotinib or Placebo in Hormone Receptor-Positive Metastatic Breast Cancer (MBC) Subjects Who Progressed on First Line Hormonal Therapy

• Status: Terminated
• Trial end date: 2017-12-01

Summary

This is a multicenter, randomized, double-blind study of fulvestrant plus erlotinib versus fulvestrant plus placebo for subjects with metastatic breast cancer whose disease progression after first line hormonal therapy.

1. To obtain preliminary estimates of the magnitude and variability of the efficacy of fulvestrant in combination with erlotinib in this subject population, and

2. To obtain historically up-to-date estimates of the magnitude and variability of the efficacy of fulvestrant as the sole active agent in this subject population.

The measure of efficacy for both primary objectives will be time to progression.

• Phase: Phase 2

Details

• Lead Sponsor: University of Arkansas
• Collaborator: OSI Pharmaceuticals
• Treatments: Erlotinib Hydrochloride; Estradiol; Fulvestrant; Hormones