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

Phase 1TerminatedNCT01596530

AstraZeneca3 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Breast Neoplasm

Interventions

Drug-AZD8931DRUG

Active drug for biological activity

Drug-PlaceboDRUG

Placebo comparator for biological activity comparison

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Research Site

Düsseldorf, Germany

Research Site

Essen, Germany

Research Site

Wittenberg, Germany

Research Site

Seoul, South Korea

Research Site

Outcomes

Primary Outcomes

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

Time frame: Day 7 - Day 14

Secondary Outcomes

Comparison of the effects of AZD8931 versus placebo on p-EGFR, p-erbB2, p-erbB3 NUCLEAR p-Mapk, p-AKT and Ki67 after 7 or more days of treatment

Time frame: Day 7 - Day 14

Assessment sof the safety and tolerability of AZD8931 as assessed by incidence of adverse events during the course of the study.

Time frame: From study entry through to 30 days post treatment (Day 44 maximum)

Assessment of the plasma PK of AZD8931

Time frame: Day 1 - Day 14

Comparison of the effects of AZD8931 versus placebo on other biomarkers including but not limited to, erbB ligands, pER, PTEN, erbB receptor homo- and hetero- dimers, total MAPK, apoptosis markers and total AKT after 7 or more days of treatment.

Time frame: Day 7 - Day 14

Establishing the baseline tumour characteristics, including but not limited to ER, PR and HER-2 status

Time frame: Day -28 to Day 0

Exploration of the relationship between AZD8931 exposure (PK in plasma and tumour) and a selection of secondary biomarkers (e.g. p-EGFR, nuclear p-MAPK, Ki67 and apoptosis markers after ?7 days of treatment), if possible.

Time frame: Day 1 - Day 14

Change from baseline in laboratory, vitals signs and ECG data

Time frame: Day 1 - Day 14

Data from ClinicalTrials.gov

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