Study of Faslodex With or Without Concomitant Arimidex Versus Exemestane Following Progression on Non-steroidal Aromatase Inhibitors (NSAI)

August 26, 2011 updated by: AstraZeneca

A Partially-blind Phase III Randomised Trial of Fulvestrant (Faslodex) With or Without Concomitant Anastrozole (Arimidex) Compared With Exemestane in Postmenopausal Women With ER+ve Locally Advanced/Metastatic Breast Cancer Following Progression on Non-steroidal Aromatase Inhibitors

A partially-blind, randomised, multicentre phase III trial of Faslodex plus concomitant Arimidex versus Faslodex plus Arimidex-Placebo versus exemestane in postmenopausal locally advanced / metastatic breast cancer patients who have progressed on NSAIs. Randomisation to Faslodex ± Arimidex / Arimidex-Placebo or exemestane will be open (1:1:1). For Faslodex treated patients the randomisation to Arimidex or Arimidex-Placebo will be double-blind.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 3

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

  • Korea, Republic of
      • Ilsan, Korea, Republic of
        • Research Site
      • Seoul, Korea, Republic of
        • 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:

  • Histologically or cytologically confirmed adenocarcinoma of the breast.
  • Metastatic disease must be measurable or evaluable
  • Relapsed or progressed during prior treatment with single-agent NSAI, meeting either of the following criteria:
  • NSAI given as adjuvant therapy that lasted ≥ 12 months OR
  • Achieved an objective CR, PR, or SD that that lasted ≥ 6 months after prior 1st-line
  • Female postmenopausal patients

Exclusion Criteria:

  • Hormone receptor status1. ER -ve and PgR NK2. ER-ve and PgR -ve3. ER NK
  • Prescribed Tamoxifen for metastatic disease
  • Rapidly progressive visceral disease
  • Patients with malignancies within the last 5 years.

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
fulvestrant and anastrozole
Drug: fulvestrant
Intramuscular injection on days 1, 15, and 29 and then once monthly until disease progression.
Other Names:
  • Faslodex
Drug: anastrozole
Tablet, oral, once daily until disease progression.
Other Names:
  • Arimidex
Experimental: 2
fulvestrant and placebo
Drug: fulvestrant
Intramuscular injection on days 1, 15, and 29 and then once monthly until disease progression.
Other Names:
  • Faslodex
Active Comparator: 3
exemestane alone
Drug: exemestane
Tablet, oral, once daily until disease progression.
Other Names:
  • Aromasin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: every 3 months during treatment and, at time of discontinuation from treatment
every 3 months during treatment and, at time of discontinuation from treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective complete response (CR) and partial response (PR) rate
Time Frame: every 3 months during treatment and, at time of discontinuation from treatment
every 3 months during treatment and, at time of discontinuation from treatment
Duration of response
Time Frame: every 3 months during treatment and, at time of discontinuation from treatment
every 3 months during treatment and, at time of discontinuation from treatment
Clinical benefit (i.e., 6-month CR, PR, and stable disease) rate
Time Frame: every 3 months during treatment and, at time of discontinuation from treatment
every 3 months during treatment and, at time of discontinuation from treatment

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Young-Huck Im, Professor(Samsung Medical Center)

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.

General Publications

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

December 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

July 22, 2009

First Submitted That Met QC Criteria

July 22, 2009

First Posted (Estimate)

July 23, 2009

Study Record Updates

Last Update Posted (Estimate)

August 29, 2011

Last Update Submitted That Met QC Criteria

August 26, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9238UK/0005

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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