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NCT00099437Active, not recruitingPhase 3

Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy.

A Randomised, Double-Blind, Parallel-group, Multicentre, Phase III Study Comparing the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg With Fulvestrant (FASLODEX™) 250 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy

Source: ClinicalTrials.gov · Last updated 14 Sept 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate the efficacy of a new dose of 500 mg Fulvestrant with the standard dose of 250 mg in postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed on a previous endocrine treatment.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
736 (actual)
First submitted
13 Dec 2004
Start date
13 Feb 2005
Primary completion date
27 Feb 2009
Lead sponsor
AstraZeneca
NCT number
NCT00099437
EudraCT number
2004-002371-16

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 736
  • From 13 Feb 2005 to the primary completion date, 27 Feb 2009
  • 93 sites in 17 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Treatment with an investigational or non-approved drug within one month
  • Treatment with more than one regimen of chemotherapy for advanced breast cancer
  • Treatment with more than one regimen of hormonal treatment for advanced breast cancer

Other illness

  • 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 (i.e. castor oil)

Who the study is looking for

  • Breast Cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor
  • Requiring hormonal treatment
  • Postmenopausal women defined as a woman who has stopped having menstrual periods
  • Evidence of positive estrogen receptor hormone sensitivity
  • Written informed consent to participate in the trial

Age in the registry: 45 years to 130 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (93)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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BrasschaatBelgiumUnknown status
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BrusselsBelgiumUnknown status
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EdegemBelgiumUnknown status
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GhentBelgiumUnknown status
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HasseltBelgiumUnknown status
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LiègeBelgiumUnknown status
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TurnhoutBelgiumUnknown status
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BarretosBrazilUnknown status
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LondrinaBrazilUnknown status
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Porto AlegreBrazilUnknown status
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RecifeBrazilUnknown status
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SalvadorBrazilUnknown status
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São PauloBrazilUnknown status
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AntofagastaChileUnknown status
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SantiagoChileUnknown status
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BogotáColombiaUnknown status
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CaliColombiaUnknown status
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BrnoCzechiaUnknown status
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České BudějoviceCzechiaUnknown status
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PardubiceCzechiaUnknown status
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PragueCzechiaUnknown status
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TáborCzechiaUnknown status
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V Uvalu 84CzechiaUnknown status
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A CoruñaSpainUnknown status
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MadridSpainUnknown status
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MálagaSpainUnknown status
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OviedoSpainUnknown status
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SalamancaSpainUnknown status
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SevilleSpainUnknown status
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NyíregyházaHungaryUnknown status
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SzékesfehérvárHungaryUnknown status
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SzombathelyHungaryUnknown status
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AnsārinagarIndiaUnknown status
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BhopalIndiaUnknown status
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HyderabadIndiaUnknown status
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JaipurIndiaUnknown status
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KolkataIndiaUnknown status
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ManipalIndiaUnknown status
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Marg JaipurIndiaUnknown status
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MumbaiIndiaUnknown status
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PuneIndiaUnknown status
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TrivandrumIndiaUnknown status
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VelloreIndiaUnknown status
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AvianoItalyUnknown status
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BergamoItalyUnknown status
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CarpiItalyUnknown status
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GenovaItalyUnknown status
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PratoItalyUnknown status
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Reggio EmiliaItalyUnknown status
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VareseItalyUnknown status
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FlorianaMaltaUnknown status
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MéxicoMexicoUnknown status
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Mexico CityMexicoUnknown status
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BialystokPolandUnknown status
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LodzPolandUnknown status
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PoznanPolandUnknown status
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IvanovoRussiaUnknown status
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Kazan, TatarstanRussiaUnknown status
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KrasnodarRussiaUnknown status
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LipetskRussiaUnknown status
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MoscowRussiaUnknown status
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Nizhny NovgorodRussiaUnknown status
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ObninskRussiaUnknown status
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RyazanRussiaUnknown status
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Saint PetersburgRussiaUnknown status
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YaroslavlRussiaUnknown status
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BardejovSlovakiaUnknown status
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BratislavaSlovakiaUnknown status
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NitraSlovakiaUnknown status
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TrnavaSlovakiaUnknown status
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CherkasyUkraineUnknown status
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DniproUkraineUnknown status
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DonetskUkraineUnknown status
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KyivUkraineUnknown status
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LvivUkraineUnknown status
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SumyUkraineUnknown status
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TernopilUkraineUnknown status
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UzhhorodUkraineUnknown status
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Casa GrandeUnited StatesUnknown status
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Crystal RiverUnited StatesUnknown status
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DetroitUnited StatesUnknown status
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Fort LauderdaleUnited StatesUnknown status
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Fountain ValleyUnited StatesUnknown status
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GreenvilleUnited StatesUnknown status
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Kansas CityUnited StatesUnknown status
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New BritainUnited StatesUnknown status
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PasadenaUnited StatesUnknown status
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RosedaleUnited StatesUnknown status
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St LouisUnited StatesUnknown status
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UrbanaUnited StatesUnknown status
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Voorhees TownshipUnited StatesUnknown status
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West BendUnited StatesUnknown status
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CaracasVenezuelaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.