Phase II Study of Erlotinib, an EGFR Inhibitor in Metastatic EGFR-positive 'Triple Receptor-negative' Breast Cancer

Summary

The goal of this clinical research study is to learn if Tarceva® (erlotinib hydrochloride) can help control triple receptor-negative breast cancer. The safety of this drug will also be studied. Objectives: To assess the clinical efficacy, biologic effects and safety of the EGFR inhibitor erlotinib in the treatment of patients with 'triple receptor-negative' metastatic carcinoma of the breast. Primary endpoints: 1\) Time to progression (TTP) Secondary endpoints: 1. clinical benefit rate as defined by complete and partial response and stable disease 2. overall survival (OS) 3. safety profile and tolerability of erlotinib 4. biologic correlative studies

Timeline

Start

2008-07

Primary completion

2010-11

Completion

2010-11

Outcome

Outcome not reported

Stopped (Enrollment): “Poor Accrual”

Drugs

Indications