Comparing Anastrozole-Placebo to the Combination Anastrozole-ZD1839 in Postmenopausal Patients With Estrogen Receptor and/or Progesterone Receptor Metastatic Breast Cancer

AstraZeneca174 enrolled

Overview

This study is being carried out to see if treatment with ZD1839 (Gefitinib) combined with Arimidex (Anastrozole) has improved efficacy over Arimidex alone in preventing progression of metastatic breast cancer.

This is a phase II, multicenter, double-blind, randomized, placebo-controlled trial. Patients will be randomized in a double-blind manner in a 1:1 ratio to receive either 250 mg/day ZD1839 or matched placebo in combination with 1 mg/day anastrozole. The dose of ZD1839 has been selected based on clinical studies in other tumor types suggesting identical efficacy together with a better toxicity profile in patients treated at 250 mg compared to 500 mg/day. The 1 mg dose of anastrozole is the standard approved dose.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

174

Conditions

Breast Cancer

Interventions

GefitinibDRUG

ZD1839 (gefitinib, IRESSA) 250 mg/DAY PO + 1 mg Anastrozole (ZD1033, Arimidex)

AnastrozoleDRUG

1 mg Anastrozole (ZD1033, Arimidex) + PLACEBO 1 TABLET/DAY PO

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female postmenopausal patients aged 18 years or older with newly diagnosed metastatic breast cancer. * Patients with recurrent disease during or after adjuvant tamoxifen or patients who are hormone therapy naïve are eligible for this trial. * A paraffin embedded tumor tissue block or slides from either the metastatic or primary tumor site is required. Exclusion Criteria: * Patients cannot be on hormone replacement therapy while on study. * Prior chemotherapy received for metastatic disease is not allowed. * Previous treatment with tyrosine kinase inhibitors or aromatase inhibitors is not allowed. * Patients who have evidence of an active interstitial lung disease are not eligible.

Locations (27)

Research Site

La Jolla, California, United States

Outcomes

Primary Outcomes

Time to progression

To estimate TTP in the 2 treatment arms of postmenopausal patients with newly diagnosed metastatic breast cancer

Time frame: Duration of study

Secondary Outcomes

Objective response rate

To estimate the ORR (complete response \[CR\] and partial response \[PR\] as defined by RECIST for the 2 treatment arms

Time frame: Duration of Study

Overall clinical benefit rate

To estimate the clinical benefit rates (CBR; defined as CR+PR\[as per RECIST\]+stable disease \[SD\]\>24 weeks) for the 2 treatment arms

Time frame: Duration of Study

Overall survival

To estimate overall survival (OS) for each of the 2 treatment arms

Time frame: Duration of Study

Safety

To compare the tolerability of anastrozole/placebo to that of anastrozole/ZD1839

Time frame: Duration of Study

Pharmacokinetic variables

To determine steady-state plasma trough concentrations of anastrozole in all patients. To determine steady-state trough concentrations of ZD1839 and to relate values to historical data

Time frame: Duration of Study

Biomarker objectives

To obtain tumor tissue and blood samples for biologic studies in the limited population available and measure expression of markers that may potentially correlate with response to treatment in this patient population

Time frame: Duration of Study

Data from ClinicalTrials.gov

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