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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT00065325
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
32 Years - 91 Years
Healthy Volunteers
Not accepted

Interventions

  • Fulvestrant — DRUG
    intramuscular injection
  • Exemestane — DRUG
    oral capsule

Study Details

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.

Key Dates

Start date
Aug 31, 2003
Status verified
Feb 2015
Primary completion
Jun 30, 2006
Completion
Sep 30, 2014

Study Design

Enrollment
694 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 1
    Exemestane
  • Experimental: 2
    Fulvestrant

Primary Outcome Measure

Time to disease progression (TTP) [ Time Frame: after 580 Progression events accrued ]

Locations (51)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama--
Research SiteArcadiaCalifornia--
Research SiteFountain ValleyCalifornia--
Research SiteLaverneCalifornia--
Research SiteLong BeachCalifornia--
Research SiteSanta RosaCalifornia--
Research SiteTorringtonConnecticut--
Research SiteWashington D.C.District of Columbia--
Research SiteBoca RatonFlorida--
Research SiteGainesvilleFlorida--
Research SiteJacksonvilleFlorida--
Research SiteMiamiFlorida--
Research SiteNew Port RicheyFlorida--
Research SitePensacolaFlorida--
Research SiteAthensGeorgia--
Research SiteChicagoIllinois--
Research SiteHarveyIllinois--
Research SiteSpringfieldIllinois--
Research SiteIowa CityIowa--
Research SiteOverland ParkKansas--
Research SiteBaton RougeLouisiana--
Research SiteMetairieLouisiana--
Research SiteNew OrleansLouisiana--
Research SiteShreveportLouisiana--
Research SiteBangorMaine--
Research SiteBaltimoreMaryland--
Research SiteFrederickMaryland--
Research SiteKalamazooMichigan--
Research SiteRoyal OakMichigan--
Research SiteSaint JosephMichigan--
Research SiteHooksettNew Hampshire--
Research SiteLivingstonNew Jersey--
Research SiteVoorhees TownshipNew Jersey--
Research SiteAlbuquerqueNew Mexico--
Research SiteCharlotteNorth Carolina--
Research SiteDurhamNorth Carolina--
Research SiteCantonOhio--
Research SiteHersheyPennsylvania--
Research SiteLancasterPennsylvania--
Research SiteLanghornePennsylvania--
Research SitePittsburghPennsylvania--
Research SiteProvidenceRhode Island--
Research SiteColumbiaSouth Carolina--
Research SiteGreenvilleSouth Carolina--
Research SiteSpartenburgSouth Carolina--
Research SiteAustinTexas--
Research SiteDallasTexas--
Research SiteHoustonTexas--
Research SiteSan AntonioTexas--
Research SiteBurlingtonVermont--
Research SiteRichmondVirginia--

Find similar trials in Birmingham, AL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Research Site· Birmingham, ALResearch Site· Arcadia, CAResearch Site· Fountain Valley, CAResearch Site· Laverne, CAResearch Site· Long Beach, CAResearch Site· Santa Rosa, CA

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