Completed

Phase II Multicenter, Double-Blind, Randomized Trial Comparing Anastrozole (ZD1033, Arimidex™)-Placebo to the Combination Anastrozole-ZD1839 (Gefitinib, IRESSA™) in Postmenopausal Patients With Estrogen Receptor (ER) and/or Progesterone Receptor (PgR) Metastatic Breast Cancer

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What is being tested

Gefitinib

+ Anastrozole
Drug
Who is being recruted

Breast Diseases
+2

+ Breast Neoplasms
+ Neoplasms
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 2004
See protocol details

Summary

Principal SponsorAstraZeneca
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2004Actual date on which the first participant was enrolled.

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.

Official TitlePhase II Multicenter, Double-Blind, Randomized Trial Comparing Anastrozole (ZD1033, Arimidex™)-Placebo to the Combination Anastrozole-ZD1839 (Gefitinib, IRESSA™) in Postmenopausal Patients With Estrogen Receptor (ER) and/or Progesterone Receptor (PgR) Metastatic Breast Cancer 
NCT00077025
Principal SponsorAstraZeneca
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
174 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Breast Diseases
Breast Neoplasms
Neoplasms
Neoplasms by Site
Skin Diseases
Criteria

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Active Comparator
Anastrozole (ZD1033, Arimidex)-ZD1839 (gefitinib, IRESSA)

ZD1839 (gefitinib, IRESSA) 250 mg/DAY PO + 1 mg Anastrozole (ZD1033, Arimidex)
Group II
Active Comparator
Anastrozole (ZD1033, Arimidex)-Placebo

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

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

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

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

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

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

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

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 27 locations
Suspended
Research SiteLa Jolla, United StatesSee the location
Suspended
Research SiteSan Diego, United States
Suspended
Research SiteOrlando, United States
Suspended
Research SiteLafayette, United States
Completed27 Study Centers