A Study of ZD1839 Effects on Cell Proliferation in Breast Cancer

A Phase II, Randomised, Double-Blind, Placebocontrolled Study To Investigate The Effects Of ZD1839 (IRESSA™) On Cell Proliferation In Oestrogen And Progesterone Receptor Negative Breast Cancer Prior To Surgery

This is a Phase II, randomised, double-blind, placebo-controlled study. Subjects with histologically-confirmed oestrogen receptor negative (ER-), progesterone receptor negative (PgR-) primary breast cancer breast cancer will be randomly assigned in a 2:1 ratio to receive ZD1839 250 mg once daily or matching placebo for a total period of 5 weeks. Surgical intervention will take place after 4 weeks (on Day 29) and treatment will continue for 1 week after surgery.

Inclusion Criteria:

• Histologically-confirmed ER- and PgR- primary breast cancer
• Stage T .5 cm, N0-1, M0
• No previous treatment for breast cancer

Exclusion Criteria:

• ALT or AST greater than 2.5 times the ULRR
• Metastatic disease