NCT00077025

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_2 breast-cancer

Geographic Reach
4 countries

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 11, 2004

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

July 16, 2014

Status Verified

July 1, 2014

Enrollment Period

9.3 years

First QC Date

February 9, 2004

Last Update Submit

July 15, 2014

Conditions

Breast Cancer

Keywords

metastatic breast cancer

Outcome Measures

Primary Outcomes (1)

  • Time to progression

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

    Duration of study

Secondary Outcomes (6)

  • Objective response rate

    Duration of Study

  • Overall clinical benefit rate

    Duration of Study

  • Overall survival

    Duration of Study

  • Safety

    Duration of Study

  • Pharmacokinetic variables

    Duration of Study

  • +1 more secondary outcomes

Study Arms (2)

Anastrozole-placebo

ACTIVE COMPARATOR

Anastrozole (ZD1033, Arimidex)-Placebo

Drug: Anastrozole

Anastrozole-ZD1839

ACTIVE COMPARATOR

Anastrozole (ZD1033, Arimidex)-ZD1839 (gefitinib, IRESSA)

Drug: Gefitinib

Interventions

GefitinibDRUG

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

Also known as: IRESSA
Anastrozole-ZD1839
AnastrozoleDRUG

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

Also known as: Arimidex
Anastrozole-placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Research Site

La Jolla, California, United States

Location

Research Site

San Diego, California, United States

Location

Research Site

Orlando, Florida, United States

Location

Research Site

Lafayette, Louisiana, United States

Location

Research Site

Rockville, Maryland, United States

Location

Research Site

Columbia, Missouri, United States

Location

Research Site

Omaha, Nebraska, United States

Location

Research Site

Las Vegas, Nevada, United States

Location

Research Site

Voorhees Township, New Jersey, United States

Location

Research Site

Albuquerque, New Mexico, United States

Location

Research Site

Lake Success, New York, United States

Location

Research Site

Cincinnati, Ohio, United States

Location

Research Site

Allentown, Pennsylvania, United States

Location

Research Site

Sioux Falls, South Dakota, United States

Location

Research Site

Houston, Texas, United States

Location

Research Site

Temple, Texas, United States

Location

Research Site

Cali, Colombia

Location

Research Site

Aguascalientes, Mexico

Location

Research Site

Guadalajara, Mexico

Location

Research Site

Morelia, Mexico

Location

Research Site

Barcelona, Venezuela

Location

Research Site

Barquisimeto, Venezuela

Location

Research Site

Caracas, Venezuela

Location

Research Site

Maracaibo, Venezuela

Location

Research Site

Puerto Ordaz and San Felix, Venezuela

Location

Research Site

San Cristóbal, Venezuela

Location

Research Site

Valencia, Venezuela

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

GefitinibAnastrozole

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Iressa Medical Science Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2004

First Posted

February 11, 2004

Study Start

January 1, 2004

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

July 16, 2014

Record last verified: 2014-07

Locations

VE(7)CO(1)ME(3)US(16)