A Study of ZD1839 Effects on Cell Proliferation in Breast Cancer

AstraZeneca

Status and phase: Withdrawn; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Gefitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00252811

D7913C00509 (Other Identifier)

1839IL/0509

Details and patient eligibility

About

This is a Phase II, randomised, double-blind, placebo-controlled study. Subjects with histologically-confirmed oestrogen receptor negative (ER-), progesterone receptor negative (PgR-) primary breast cancer breast cancer will be randomly assigned in a 2:1 ratio to receive ZD1839 250 mg once daily or matching placebo for a total period of 5 weeks. Surgical intervention will take place after 4 weeks (on Day 29) and treatment will continue for 1 week after surgery.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically-confirmed ER- and PgR- primary breast cancer
• Stage T .5 cm, N0-1, M0
• No previous treatment for breast cancer

Exclusion criteria

• ALT or AST greater than 2.5 times the ULRR
• Metastatic disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind