Overview

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

Status:
Terminated
Trial end date:
2013-05-01
Target enrollment:
0
Participant gender:
Female
Summary
To compare the activity of AZD8931 against placebo on the cell markers in cancer tumours
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Criteria
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