The Evaluation of the Efficacy and Tolerability of FASLODEX (Fulvestrant) and AROMASIN (Exemestane) in Hormone Receptor Positive Postmenopausal Women With Advanced Breast Cancer
EFECT
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
3 other identifiers
interventional
694
15 countries
117
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2003
Longer than P75 for phase_3
117 active sites
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
First Submitted
Initial submission to the registry
July 21, 2003
CompletedFirst Posted
Study publicly available on registry
July 23, 2003
CompletedStudy Start
First participant enrolled
August 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedFebruary 24, 2015
February 1, 2015
2.8 years
July 21, 2003
February 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to disease progression (TTP)
after 580 Progression events accrued
Secondary Outcomes (7)
Objective response rate
after 580 Progression events accrued
Overall survival
after 580 Progression events accrued
Duration of response
after 580 Progression events accrued
Clinical Benefit
after 580 Progression events accrued
Quality of Life
after 580 Progression events accrued
- +2 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATORExemestane
2
EXPERIMENTALFulvestrant
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (117)
Research Site
Birmingham, Alabama, United States
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Arcadia, California, United States
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Fountain Valley, California, United States
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Laverne, California, United States
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Long Beach, California, United States
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Santa Rosa, California, United States
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Torrington, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Boca Raton, Florida, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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New Port Richey, Florida, United States
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Pensacola, Florida, United States
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Athens, Georgia, United States
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Chicago, Illinois, United States
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Harvey, Illinois, United States
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Springfield, Illinois, United States
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Iowa City, Iowa, United States
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Overland Park, Kansas, United States
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Baton Rouge, Louisiana, United States
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Metairie, Louisiana, United States
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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Bangor, Maine, United States
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Baltimore, Maryland, United States
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Frederick, Maryland, United States
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Kalamazoo, Michigan, United States
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Royal Oak, Michigan, United States
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Saint Joseph, Michigan, United States
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Hooksett, New Hampshire, United States
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Livingston, New Jersey, United States
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Voorhees Township, New Jersey, United States
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Albuquerque, New Mexico, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Canton, Ohio, United States
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Hershey, Pennsylvania, United States
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Lancaster, Pennsylvania, United States
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Langhorne, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Providence, Rhode Island, United States
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Columbia, South Carolina, United States
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Greenville, South Carolina, United States
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Spartenburg, South Carolina, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Burlington, Vermont, United States
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Richmond, Virginia, United States
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Buenos Aires, Buenos Aires, Argentina
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Ciudad de Buenos Aires, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Rosario, Santa Fe Province, Argentina
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Brussels, Belgium, Belgium
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Leuven, Belgium, Belgium
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Ottignies, Belgium, Belgium
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Wilrijk, Belgium, Belgium
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Goiânia, Goiás, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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São Paulo, São Paulo, Brazil
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Edmonton, Alberta, Canada
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Penticton, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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St. John's, Newfoundland and Labrador, Canada
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Kingston, Ontario, Canada
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London, Ontario, Canada
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Newmarket, Ontario, Canada
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Oshawa, Ontario, Canada
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Ottawa, Ontario, Canada
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Sault Ste. Marie, Ontario, Canada
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Toronto, Ontario, Canada
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Windsor, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Aalborg, Denmark
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Herning, Denmark
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Hillerød, Denmark
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København Ø, Denmark
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Roskilde, Denmark
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Sønderborg, Denmark
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Bordeaux, France
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Lille, France
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Montpellier, France
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Vandœuvre-lès-Nancy, France
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Augsburg, Germany
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Berlin, Germany
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Hamburg, Germany
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Regensburg, Germany
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Budapest, Hungary
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Debrecen, Hungary
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Szeged, Hungary
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Haifa, Israel
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Tel Aviv, Israel
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Obninsk, Kaluga Oblast, Russia
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Moscow, Russia
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Saint Petersburg, Russia
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Klerksdorp, North West, South Africa
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Bloemfontein, South Africa, South Africa
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Cape Town, South Africa, South Africa
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Johannesburg, South Africa, South Africa
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Port Elizabeth, South Africa, South Africa
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Pretoria, South Africa, South Africa
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Seville, Andalusia, Spain
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Barcelona, Catalonia, Spain
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Hospitalet Dellobregat(barcelo, Catalonia, Spain
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Terrassa(barcelona), Catalonia, Spain
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Madrid, Madrid, Spain
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Valencia, Valencia, Spain
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Halmstad, Sweden
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Lund, Sweden
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Stockholm, Sweden
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Uppsala, Sweden
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Nottingham, United Kingdom
Related Publications (1)
Arizmendi C, Zhu Y, Khan M, Gable J, Reeve BB, King-Kallimanis B, Bell J. The FACT-GP5 as a global tolerability measure: responsiveness and robustness to missing assessments. Qual Life Res. 2024 Oct;33(10):2869-2880. doi: 10.1007/s11136-024-03740-x. Epub 2024 Jul 24.
PMID: 39046616DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Faslodex Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2003
First Posted
July 23, 2003
Study Start
August 1, 2003
Primary Completion
June 1, 2006
Study Completion
September 1, 2014
Last Updated
February 24, 2015
Record last verified: 2015-02