Phase II Study of Erlotinib, an EGFR Inhibitor in Metastatic EGFR-positive 'Triple Receptor-negative' Breast Cancer
Status:
Terminated
Trial end date:
2010-11-01
Target enrollment:
Participant gender:
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