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

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.

This is a multicenter, randomized, double-blind study of fulvestrant plus erlotinib versus fulvestrant plus placebo for subjects with metastatic breast cancer whose disease progressed after first line hormonal therapy. * Total number of subjects planned for the trial is 130 subjects, that is, approximately 65 subjects in each arm. * Subjects will be randomized to receive fulvestrant/erlotinib (arm A) or fulvestrant/placebo (arm B) and stratified based on accrual center. * The study is a parallel-arm double-blind study, with fulvestrant + placebo on the monotherapy arm, and fulvestrant + erlotinib on the combination arm. * The primary variable outcome is time to progression. * Subjects whose metastatic disease was diagnosed more than 12 months after completing adjuvant hormonal therapy are eligible to this study if their breast cancer is hormone-receptor-positive and after disease progression on first line hormonal therapy in the metastatic setting. Subjects may have received no more than one line of chemotherapy. While receiving one line of hormonal therapy in the metastatic setting is a requirement, receiving chemotherapy is not, and one line of chemotherapy in the metastatic setting would not exclude these subjects from the trial. Subjects who had a recurrence while on adjuvant hormonal treatment or within 12 months of completion of the adjuvant hormonal treatment are also eligible without the need to receive first line hormonal therapy in the metastatic setting.