The Evaluation of the Efficacy and Tolerability of FASLODEX (Fulvestrant) and AROMASIN (Exemestane) in Hormone Receptor Positive Postmenopausal Women With Advanced Breast Cancer (EFECT)

February 23, 2015 updated by: AstraZeneca

A Randomized, Double Blind, Multicenter Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) vs. Exemestane (AROMASIN™) in Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer With Disease Progression After Prior Non-Steroidal Aromatase Inhibitor (AI) Therapy

The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Aromasin (exemestane) in hormone receptor positive postmenopausal women with advanced breast cancer. Patients will be treated until disease progression or until the investigator has determined that treatment is not in the best interest of the patient, whichever occurs first.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

694

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

  • Argentina
      • Buenos Aires, Argentina
        • Research Site
    • Buenos Aires
      • Ciudad de Buenos Aires, Buenos Aires, Argentina
        • Research Site
      • Mar Del Plata, Buenos Aires, Argentina
        • Research Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina
        • Research Site
  • Belgium
      • Brussels, Belgium
        • Research Site
      • Leuven, Belgium
        • Research Site
      • Ottignies, Belgium
        • Research Site
      • Wilrijk, Belgium
        • Research Site
  • Brazil
    • GO
      • Goiania, GO, Brazil
        • Research Site
    • RJ
      • Rio de Janeiro, RJ, Brazil
        • Research Site
    • RS
      • Porto Alegre, RS, Brazil
        • Research Site
    • SP
      • Sao Paulo, SP, Brazil
        • Research Site
  • Canada
      • Quebec, Canada
        • Research Site
    • Alberta
      • Edmonton, Alberta, Canada
        • Research Site
    • British Columbia
      • Penticton, British Columbia, Canada
        • Research Site
      • Vancouver, British Columbia, Canada
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Research Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada
        • Research Site
    • Ontario
      • Kingston, Ontario, Canada
        • Research Site
      • London, Ontario, Canada
        • Research Site
      • Newmarket, Ontario, Canada
        • Research Site
      • Oshawa, Ontario, Canada
        • Research Site
      • Ottawa, Ontario, Canada
        • Research Site
      • Sault Ste. Marie, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
      • Windsor, Ontario, Canada
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada
        • Research Site
  • Denmark
      • Alborg, Denmark
        • Research Site
      • Herning, Denmark
        • Research Site
      • Hillerod, Denmark
        • Research Site
      • Kobenhavn O, Denmark
        • Research Site
      • Roskilde, Denmark
        • Research Site
      • Sonderborg, Denmark
        • Research Site
  • France
      • Bordeaux Cedex, France
        • Research Site
      • Lille Cedex, France
        • Research Site
      • Montpellier Cedex 5, France
        • Research Site
      • Vandoeuvre Les Nancy, France
        • Research Site
  • Germany
      • Augsburg, Germany
        • Research Site
      • Berlin, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Regensburg, Germany
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Debrecen, Hungary
        • Research Site
      • Szeged, Hungary
        • Research Site
  • Israel
      • Haifa, Israel
        • Research Site
      • Tel-aviv, Israel
        • Research Site
  • Russian Federation
      • Moscow, Russian Federation
        • Research Site
      • St-petersburg, Russian Federation
        • Research Site
    • Kaluga Region
      • Obninsk, Kaluga Region, Russian Federation
        • Research Site
  • South Africa
      • Bloemfontein, South Africa
        • Research Site
      • Cape Town, South Africa
        • Research Site
      • Johannesburg, South Africa
        • Research Site
      • Port Elizabeth, South Africa
        • Research Site
      • Pretoria, South Africa
        • Research Site
    • North West Province
      • Klerksdorp, North West Province, South Africa
        • Research Site
  • Spain
    • Andalucia
      • Sevilla, Andalucia, Spain
        • Research Site
    • Cataluna
      • Barcelona, Cataluna, Spain
        • Research Site
      • Hospitalet Dellobregat(barcelo, Cataluna, Spain
        • Research Site
      • Terrassa(barcelona), Cataluna, Spain
        • Research Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain
        • Research Site
    • Comunidad de Madrid
      • Madrid, Comunidad de Madrid, Spain
        • Research Site
  • Sweden
      • Halmstad, Sweden
        • Research Site
      • Lund, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site
      • Uppsala, Sweden
        • Research Site
  • United Kingdom
      • Nottingham, United Kingdom
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Research Site
    • California
      • Arcadia, California, United States
        • Research Site
      • Fountain Valley, California, United States
        • Research Site
      • Laverne, California, United States
        • Research Site
      • Long Beach, California, United States
        • Research Site
      • Santa Rosa, California, United States
        • Research Site
    • Connecticut
      • Torrington, Connecticut, United States
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, United States
        • Research Site
    • Florida
      • Boca Raton, Florida, United States
        • Research Site
      • Gainesville, Florida, United States
        • Research Site
      • Jacksonville, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
      • New Port Richey, Florida, United States
        • Research Site
      • Pensacola, Florida, United States
        • Research Site
    • Georgia
      • Athens, Georgia, United States
        • Research Site
    • Illinois
      • Chicago, Illinois, United States
        • Research Site
      • Harvey, Illinois, United States
        • Research Site
      • Springfield, Illinois, United States
        • Research Site
    • Iowa
      • Iowa City, Iowa, United States
        • Research Site
    • Kansas
      • Overland Park, Kansas, United States
        • Research Site
    • Louisiana
      • Baton Rouge, Louisiana, United States
        • Research Site
      • Metairie, Louisiana, United States
        • Research Site
      • New Orleans, Louisiana, United States
        • Research Site
      • Shreveport, Louisiana, United States
        • Research Site
    • Maine
      • Bangor, Maine, United States
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States
        • Research Site
      • Frederick, Maryland, United States
        • Research Site
    • Michigan
      • Kalamazoo, Michigan, United States
        • Research Site
      • Royal Oak, Michigan, United States
        • Research Site
      • St Joseph, Michigan, United States
        • Research Site
    • New Hampshire
      • Hooksett, New Hampshire, United States
        • Research Site
    • New Jersey
      • Livingston, New Jersey, United States
        • Research Site
      • Voorhees, New Jersey, United States
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States
        • Research Site
      • Durham, North Carolina, United States
        • Research Site
    • Ohio
      • Canton, Ohio, United States
        • Research Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States
        • Research Site
      • Lancaster, Pennsylvania, United States
        • Research Site
      • Langhorne, Pennsylvania, United States
        • Research Site
      • Pittsburgh, Pennsylvania, United States
        • Research Site
    • Rhode Island
      • Providence, Rhode Island, United States
        • Research Site
    • South Carolina
      • Columbia, South Carolina, United States
        • Research Site
      • Greenville, South Carolina, United States
        • Research Site
      • Spartenburg, South Carolina, United States
        • Research Site
    • Texas
      • Austin, Texas, United States
        • Research Site
      • Dallas, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
    • Vermont
      • Burlington, Vermont, United States
        • Research Site
    • Virginia
      • Richmond, Virginia, United States
        • 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

32 years to 91 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Biopsy confirmation of Breast Cancer
  • Breast Cancer has continued to grow after having received treatment with an aromatase inhibitor
  • Postmenopausal women defined as a women who has stopped having menstrual periods
  • Evidence of hormone sensitivity
  • Written informed consent to participate in the trial

Exclusion Criteria:

  • Previous treatment with Faslodex (fulvestrant) or Aromasin (exemestane)
  • Any hormonal therapy used to modify the course of an additional medical condition after prior treatment with a non-steroidal aromatase inhibitor
  • Treatment with an investigational or non-approved drug within one month
  • An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
  • A history of allergies to any active or inactive ingredients of Faslodex or Exemestane (i.e. castor oil or Mannitol)

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
Fulvestrant
Drug: Fulvestrant
intramuscular injection
Other Names:
  • Faslodex
  • ZD9238
Active Comparator: 1
Exemestane
Drug: Exemestane
oral capsule
Other Names:
  • AROMASIN™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to disease progression (TTP)
Time Frame: after 580 Progression events accrued
after 580 Progression events accrued

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective response rate
Time Frame: after 580 Progression events accrued
after 580 Progression events accrued
Overall survival
Time Frame: after 580 Progression events accrued
after 580 Progression events accrued
Duration of response
Time Frame: after 580 Progression events accrued
after 580 Progression events accrued
Clinical Benefit
Time Frame: after 580 Progression events accrued
after 580 Progression events accrued
Quality of Life
Time Frame: after 580 Progression events accrued
after 580 Progression events accrued
PK
Time Frame: each visit
each visit
Safety and tolerability.
Time Frame: after 580 Progression events accrued
after 580 Progression events accrued

Collaborators and Investigators

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

Sponsor

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

August 1, 2003

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

July 21, 2003

First Submitted That Met QC Criteria

July 22, 2003

First Posted (Estimate)

July 23, 2003

Study Record Updates

Last Update Posted (Estimate)

February 24, 2015

Last Update Submitted That Met QC Criteria

February 23, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9238IL/0048
  • EFECT
  • D6997C00048

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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