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 India 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

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)

Facility	City	Region
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.

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Assessment of the Breast Cosmesis Using Deep Neural Networks: an Exploratory Study (ABCD) Recruiting

A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05) Recruiting

Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer Active, not recruiting

A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy (TROPION-Breast02) Active, not recruiting

KORTUC Phase II - Intra-tumoural Radiation Sensitizer in Patients With Locally Advanced/Recurrent Breast Cancer Active, not recruiting

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 India