Evaluation of Drug Activity in Women With Breast Cancer and no Previous Herceptin Treatment

A Randomised Double-Blind Placebo-controlled Multicentre Phase I Study to Assess the Biological Activity of AZD8931 in Patients With Early Breast Cancer Who Are Ineligible for Treatment With Trastuzumab as Defined by IHC Status

To compare the activity of AZD8931 against placebo on the cell markers in cancer tumours

A Randomised Double-Blind Placebo-controlled Multicentre Phase I Study to Assess the Biological Activity of AZD8931 in Patients with Early Breast Cancer who are Ineligible for Treatment with trastuzumab as defined by IHC status

Inclusion Criteria:

• Females aged 18 or older Early stage breast cancer and planned surgery
• Ineligible for Trastuzumab (Herceptin) treatment as per local guidelines
• World health Organisation performance status of 0 to 1 Tumour size amenable to obtaining adequate biopsies pre dosing.

Exclusion Criteria:

• Eligible for Trastuzumab (Herceptin) Treatment Known sensitivity to AZD8931, its excipients or drugs in its class;
• Including oral tyrosine kinase inhibitors History of eye conditions e.g. previous injury within 3 months or clinically significant eye disease
• Concurrent malignancy Unable to discontinue medication or herbal supplement known to inhibit CYP3A4 or CYP2D6