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

NCT ID: NCT01596530

Last Updated: 2012-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-05-31

Brief Summary

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

Detailed Description

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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

Conditions

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Breast Neoplasm

Keywords

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Breast Neoplasm Breast Cancer Breast Tumour Cancer of Breast Cancer of the Breast

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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AZD8931

AZD8931

Group Type ACTIVE_COMPARATOR

Drug-AZD8931

Intervention Type DRUG

Active drug for biological activity

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Drug-Placebo

Intervention Type DRUG

Placebo comparator for biological activity comparison

Interventions

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Drug-AZD8931

Active drug for biological activity

Intervention Type DRUG

Drug-Placebo

Placebo comparator for biological activity comparison

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Serban Ghiorghiu, M.D.

Role: STUDY_DIRECTOR

Internal

Locations

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Research Site

Düsseldorf, , Germany

Site Status

Research Site

Essen, , Germany

Site Status

Research Site

Wittenberg, , Germany

Site Status

Research Site

Seoul, , South Korea

Site Status

Research Site

Yonsei, , South Korea

Site Status

Research Site

Taichung, , Taiwan

Site Status

Research Site

Taipei, , Taiwan

Site Status

Countries

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Germany South Korea Taiwan

Other Identifiers

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D0102C00019

Identifier Type: -

Identifier Source: org_study_id