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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


Phase 1
18 Years
N/A
Not Enrolling
Female
Breast Neoplasm

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Outcome Measure:

Comparison of the effects of AZD8931 versus placebo on cytoplasmic p-MAPK after 7 days or more days of treatment

Outcome Time Frame:

Day 7 - Day 14

Safety Issue:

Yes

Principal Investigator

Serban Ghiorghiu, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Internal

Authority:

Germany: Ministry of Health

Study ID:

D0102C00019

NCT ID:

NCT01596530

Start Date:

June 2012

Completion Date:

May 2013

Related Keywords:

  • Breast Neoplasm
  • Breast Neoplasm
  • Breast Cancer
  • Breast Tumour
  • Cancer of Breast
  • Cancer of the Breast
  • Breast Neoplasms
  • Neoplasms

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