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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 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 736

Last updated 2026-03-18

Study results available
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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.

Conditions

Interventions

DRUG

Fulvestrant

intramuscular injection

Sponsors & Collaborators

Principal Investigators

  • Faslodex Medical Science Director, MD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
130 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-13
Primary Completion
2009-02-27
Completion
2026-12-31

Countries

  • United States
  • Belgium
  • Brazil
  • Chile
  • Colombia
  • Czechia
  • Hungary
  • India
  • Italy
  • Malta
  • Mexico
  • Poland
  • Russia
  • Slovakia
  • Spain
  • Ukraine
  • Venezuela

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00099437 on ClinicalTrials.gov