Second Line Breast Cancer Trial

April 9, 2009 updated by: AstraZeneca

A Double-Blind, Randomized, Multi-Center Trial Comparing the Efficacy and Tolerability of 125 and 250mg of Faslodex (Long Acting ICI 182,780) With 1mg Arimidex (Anastrazole) in Postmenopausal Women With Advanced Breast Cancer.

The main purpose of this study is to compare the effect of 2 doses of FASLODEX with 1 dose of ARIMIDEX in terms of time to tumor progression in postmenopausal women with advanced breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

588

Phase

  • Phase 3

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:

  • postmenopausal women with confirmation of breast cancer
  • objective evidence of recurrence or progression of breast cancer no more than 1 prior hormonal therapy for breast cancer

Exclusion Criteria:

  • presence of life-threatening metastatic visceral disease
  • previous treatment with FASLODEX, ARIMIDEX or any aromatase inhibitor for breast cancer
  • more than 1 prior endocrine medical treatment for advanced breast cancer .

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
Experimental: 1
Faslodex 125mg and Arimidex 1 mg
Drug: Fulvestrant
250mg
Other Names:
  • Faslodex
Drug: Fulvestrant
125mg
Other Names:
  • Faslodex
Drug: Anastrozole
ARIMIDEX
Experimental: 2
Faslodex 250mg and Arimidex 1mg
Drug: Fulvestrant
250mg
Other Names:
  • Faslodex
Drug: Fulvestrant
125mg
Other Names:
  • Faslodex
Drug: Anastrozole
ARIMIDEX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time to tumor progression
Time Frame: Every 3 months
Every 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
objective tumor response
Time Frame: Every 3 months
Every 3 months
time to treatment failure
Time Frame: Every 3 months
Every 3 months
time to death
Time Frame: Every 3 months
Every 3 months

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: Guido Hoctin-Boes, AstraZeneca

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

May 1, 1997

Study Completion (Actual)

September 1, 2004

Study Registration Dates

First Submitted

March 7, 2008

First Submitted That Met QC Criteria

March 13, 2008

First Posted (Estimate)

March 14, 2008

Study Record Updates

Last Update Posted (Estimate)

April 10, 2009

Last Update Submitted That Met QC Criteria

April 9, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9238IL/0021
  • D6995C00021

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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