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

July 15, 2014 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Anticipated)

174

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Cali, Colombia
        • Research Site
  • Mexico
      • Aguascalientes, Mexico
        • Research Site
      • Guadalajara, Mexico
        • Research Site
      • Morelia, Mexico
        • Research Site
  • United States
    • California
      • La Jolla, California, United States
        • Research Site
      • San Diego, California, United States
        • Research Site
    • Florida
      • Orlando, Florida, United States
        • Research Site
    • Louisiana
      • Lafayette, Louisiana, United States
        • Research Site
    • Maryland
      • Rockville, Maryland, United States
        • Research Site
    • Missouri
      • Columbia, Missouri, United States
        • Research Site
    • Nebraska
      • Omaha, Nebraska, United States
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States
        • Research Site
    • New Jersey
      • Voorhees, New Jersey, United States
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Research Site
    • New York
      • Lake Success, New York, United States
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Research Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States
        • Research Site
    • South Dakota
      • Sioux Falls, South Dakota, United States
        • Research Site
    • Texas
      • Houston, Texas, United States
        • Research Site
      • Temple, Texas, United States
        • Research Site
  • Venezuela
      • Barcelona, Venezuela
        • Research Site
      • Barquisimeto, Venezuela
        • Research Site
      • Caracas, Venezuela
        • Research Site
      • Maracaibo, Venezuela
        • Research Site
      • Puerto Ordaz, Venezuela
        • Research Site
      • San Cristobal, Venezuela
        • Research Site
      • Valencia, Venezuela
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Anastrozole-placebo
Anastrozole (ZD1033, Arimidex)-Placebo
Drug: Anastrozole
1 mg Anastrozole (ZD1033, Arimidex) + PLACEBO 1 TABLET/DAY PO
Other Names:
  • Arimidex
Active Comparator: Anastrozole-ZD1839
Anastrozole (ZD1033, Arimidex)-ZD1839 (gefitinib, IRESSA)
Drug: Gefitinib
ZD1839 (gefitinib, IRESSA) 250 mg/DAY PO + 1 mg Anastrozole (ZD1033, Arimidex)
Other Names:
  • IRESSA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to progression
Time Frame: Duration of study
To estimate TTP in the 2 treatment arms of postmenopausal patients with newly diagnosed metastatic breast cancer
Duration of study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: Duration of Study
To estimate the ORR (complete response [CR] and partial response [PR] as defined by RECIST for the 2 treatment arms
Duration of Study
Overall clinical benefit rate
Time Frame: Duration of Study
To estimate the clinical benefit rates (CBR; defined as CR+PR[as per RECIST]+stable disease [SD]>24 weeks) for the 2 treatment arms
Duration of Study
Overall survival
Time Frame: Duration of Study
To estimate overall survival (OS) for each of the 2 treatment arms
Duration of Study
Safety
Time Frame: Duration of Study
To compare the tolerability of anastrozole/placebo to that of anastrozole/ZD1839
Duration of Study
Pharmacokinetic variables
Time Frame: Duration of Study
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
Duration of Study
Biomarker objectives
Time Frame: Duration of Study
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
Duration of Study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Iressa Medical Science Director, MD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

February 9, 2004

First Submitted That Met QC Criteria

February 10, 2004

First Posted (Estimate)

February 11, 2004

Study Record Updates

Last Update Posted (Estimate)

July 16, 2014

Last Update Submitted That Met QC Criteria

July 15, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1839US/0713

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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