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Clinical Trials in Italy / NCT00099437
Active, not recruiting Phase 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.

NCT00099437 · tracked via the Priya Life Science Italy tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2005-02-13
Last updated
2026-09-14

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Fulvestrant →

Fulvestrant: intramuscular injection

Study summary

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.

Eligibility

Sex
FEMALE
Min age
45 Years
Max age
130 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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 (i.e. castor oil) * 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

Primary outcome measure(s)

  • Time to Progression (TTP) — RECIST(Response Evaluation Criteria in Solid Tumors ) tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
    Median time (in months) from randomisation until objective disease progression or death (in the absence of objective progression).

Trial sites (106)

FacilityCityRegionStatus
Research Site Casa Grande Arizona
Research Site Fountain Valley California
Research Site New Britain Connecticut
Research Site Crystal River Florida
Research Site Fort Lauderdale Florida
Research Site Urbana Illinois
Research Site Rosedale Maryland
Research Site Detroit Michigan
Research Site Kansas City Missouri
Research Site St Louis Missouri
Research Site Voorhees Township New Jersey
Research Site Greenville North Carolina
Research Site Pasadena Texas
Research Site West Bend Wisconsin
Research Site Brasschaat Belgium
Research Site Brussels Belgium
Research Site Brussels Belgium
Research Site Edegem Belgium
Research Site Ghent Belgium
Research Site Hasselt Belgium
Research Site Liège Belgium
Research Site Turnhout Belgium
Research Site Barretos Brazil
Research Site Londrina Brazil
Research Site Porto Alegre Brazil
Research Site Recife Brazil
Research Site Salvador Brazil
Research Site São Paulo Brazil
Research Site Antofagasta Chile
Research Site Santiago Chile
Research Site Santiago Chile
Research Site Bogotá Colombia
Research Site Cali Colombia
Research Site Brno Czechia
Research Site České Budějovice Czechia
Research Site Pardubice Czechia
Research Site Prague Czechia
Research Site Prague Czechia
Research Site Prague Czechia
Research Site Tábor Czechia

+ 66 more sites — see the full list on the official registry below.

More AstraZeneca trials in Italy

PASS of Paediatric Patients Initiating Selumetinib Active, not recruiting
A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer Recruiting
AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer Recruiting
Acalabrutinib Real World Italian obSErvational Study -ARISE Active, not recruiting
Observational Study on the Clinical Profile of Patients With Uncontrolled Severe Asthma Treated With Tezepelumab in Italy Active, not recruiting

Other trials for the same condition

TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study A) Active, not recruiting
The OPBC-07/microNAC Study Active, not recruiting
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2) Recruiting
Vocational Rehabilitation for the Return to Work of Breast Cancer Patients: a Feasibility Study Active, not recruiting
Music Therapy in Patients With Breast Cancer (IMPACT) Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT00099437 on ClinicalTrials.gov ↗ ← All trials in Italy