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

AstraZeneca

Status and phase: Terminated; Phase 1

Conditions: Breast Neoplasm

Treatments: Drug: Drug-Placebo; Drug: Drug-AZD8931

Study type: Interventional

Funder types: Industry

Identifiers

NCT01596530

D0102C00019

Details and patient eligibility

About

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

Full description

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

Enrollment: 3 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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3 participants in 2 patient groups, including a placebo group

AZD8931

Active Comparator group

Description:

AZD8931

Treatment:

Drug: Drug-AZD8931

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Drug-Placebo