Clinical trial NCT00065325: The Evaluation of the Efficacy and Tolerability of FASLODEX (Fulvestrant) and AROMASIN (Exemestane) in Hormone Receptor Positive Postmenopausal Women With Advanced Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Locally Advanced Breast Cancer
Metastatic Breast Cancer
Keywords: Locally advanced breast cancer
metastatic breast cancer
Breast Cancer
Cancer of Breast
Cancer of the Breast
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2003-07-23
Enrollment: 694
Sex: FEMALE
Minimum age (years): 32
Maximum age (years): 91
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Time to disease progression (TTP)
timeFrame: after 580 Progression events accrued
Secondary outcomes:
measure: Objective response rate
timeFrame: after 580 Progression events accrued
measure: Overall survival
timeFrame: after 580 Progression events accrued
measure: Duration of response
timeFrame: after 580 Progression events accrued
measure: Clinical Benefit
timeFrame: after 580 Progression events accrued
measure: Quality of Life
timeFrame: after 580 Progression events accrued
measure: PK
timeFrame: each visit
measure: Safety and tolerability.
timeFrame: after 580 Progression events accrued
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Arcadia
country: United States
facility: Research Site
state: California
city: Fountain Valley
country: United States
facility: Research Site
state: California
city: Laverne
country: United States
facility: Research Site
state: California
city: Long Beach
country: United States
facility: Research Site
state: California
city: Santa Rosa
country: United States
facility: Research Site
state: California
city: Torrington
country: United States
facility: Research Site
state: Connecticut
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Boca Raton
country: United States
facility: Research Site
state: Florida
city: Gainesville
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: New Port Richey
country: United States
facility: Research Site
state: Florida
city: Pensacola
country: United States
facility: Research Site
state: Florida
city: Athens
country: United States
facility: Research Site
state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Harvey
country: United States
facility: Research Site
state: Illinois
city: Springfield
country: United States
facility: Research Site
state: Illinois
city: Iowa City
country: United States
facility: Research Site
state: Iowa
city: Overland Park
country: United States
facility: Research Site
state: Kansas
city: Baton Rouge
country: United States
facility: Research Site
state: Louisiana
city: Metairie
country: United States
facility: Research Site
state: Louisiana
city: New Orleans
country: United States
facility: Research Site
state: Louisiana
city: Shreveport
country: United States
facility: Research Site
state: Louisiana
city: Bangor
country: United States
facility: Research Site
state: Maine
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Frederick
country: United States
facility: Research Site
state: Maryland
city: Kalamazoo
country: United States
facility: Research Site
state: Michigan
city: Royal Oak
country: United States
facility: Research Site
state: Michigan
city: St Joseph
country: United States
facility: Research Site
state: Michigan
city: Hooksett
country: United States
facility: Research Site
state: New Hampshire
city: Livingston
country: United States
facility: Research Site
state: New Jersey
city: Voorhees
country: United States
facility: Research Site
state: New Jersey
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Canton
country: United States
facility: Research Site
state: Ohio
city: Hershey
country: United States
facility: Research Site
state: Pennsylvania
city: Lancaster
country: United States
facility: Research Site
state: Pennsylvania
city: Langhorne
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Providence
country: United States
facility: Research Site
state: Rhode Island
city: Columbia
country: United States
facility: Research Site
state: South Carolina
city: Greenville
country: United States
facility: Research Site
state: South Carolina
city: Spartenburg
country: United States
facility: Research Site
state: South Carolina
city: Austin
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Burlington
country: United States
facility: Research Site
state: Vermont
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Ciudad de Buenos Aires
country: Argentina
facility: Research Site
state: Buenos Aires
city: Mar Del Plata
country: Argentina
facility: Research Site
state: Buenos Aires
city: Rosario
country: Argentina
facility: Research Site
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Ottignies
country: Belgium
facility: Research Site
city: Wilrijk
country: Belgium
facility: Research Site
city: Goiania
country: Brazil
facility: Research Site
state: GO
city: Rio de Janeiro
country: Brazil
facility: Research Site
state: RJ
city: Porto Alegre
country: Brazil
facility: Research Site
state: RS
city: Sao Paulo
country: Brazil
facility: Research Site
state: SP
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Penticton
country: Canada
facility: Research Site
state: British Columbia
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Kingston
country: Canada
facility: Research Site
state: Ontario
city: London
country: Canada
facility: Research Site
state: Ontario
city: Newmarket
country: Canada
facility: Research Site
state: Ontario
city: Oshawa
country: Canada
facility: Research Site
state: Ontario
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Sault Ste. Marie
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Windsor
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Quebec
country: Canada
facility: Research Site
city: Alborg
country: Denmark
facility: Research Site
city: Herning
country: Denmark
facility: Research Site
city: Hillerod
country: Denmark
facility: Research Site
city: Kobenhavn O
country: Denmark
facility: Research Site
city: Roskilde
country: Denmark
facility: Research Site
city: Sonderborg
country: Denmark
facility: Research Site
city: Bordeaux Cedex
country: France
facility: Research Site
city: Lille Cedex
country: France
facility: Research Site
city: Montpellier Cedex 5
country: France
facility: Research Site
city: Vandoeuvre Les Nancy
country: France
facility: Research Site
city: Augsburg
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Regensburg
country: Germany
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Haifa
country: Israel
facility: Research Site
city: Tel-aviv
country: Israel
facility: Research Site
city: Obninsk
country: Russian Federation
facility: Research Site
state: Kaluga Region
city: Moscow
country: Russian Federation
facility: Research Site
city: St-petersburg
country: Russian Federation
facility: Research Site
city: Klerksdorp
country: South Africa
facility: Research Site
state: North West Province
city: Bloemfontein
country: South Africa
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Johannesburg
country: South Africa
facility: Research Site
city: Port Elizabeth
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
state: Andalucia
city: Barcelona
country: Spain
facility: Research Site
state: Cataluna
city: Hospitalet Dellobregat(barcelo
country: Spain
facility: Research Site
state: Cataluna
city: Terrassa(barcelona)
country: Spain
facility: Research Site
state: Cataluna
city: Madrid
country: Spain
facility: Research Site
state: Comunidad de Madrid
city: Valencia
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Halmstad
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Faslodex Medical Science Director, MD
role: STUDY_DIRECTOR
References: