ANZ 0301 / BCIRG 103 (1839 IL / 0219) : Presurgical Study Evaluating IRESSA

Eligible patients will be registered to receive the tyrosine kinase inhibitor, ZD1839 (gefitinib; IRESSA) for a minimum of 14 days to a maximum of 45 days; commencing within the 8 days following registration and ceasing 24 hours prior to the time of definitive surgery. No more than 28 days should elapse between the initial breast cancer diagnosis and the first dose of ZD1839 (IRESSA). Each patient should receive a minimum of 10 consecutive days of treatment with ZD1839 (IRESSA) prior to the definitive surgery date. During the treatment period, ZD1839 (IRESSA) will be administered orally, once daily, in a 250 mg dose. Follow up of patients will continue beyond definitive surgery with the last planned clinic visit scheduled for 30 days after the last administration of ZD1839 (IRESSA). In the event that related adverse events or serious adverse events are ongoing at the last planned visit, patient follow up will continue as clinically indicated until the event/s resolve or, in the Investigator’s opinion, are unlikely to resolve due to the nature of the condition and/or the patient’s underlying disease.