A RANDOMISED, DOUBLE-BLIND, PARALLEL-GROUP, MULTICENTRE, PHASE III STUDYCOMPARING 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
Phase 1
Active, not recruiting
- Conditions
- ADVANCED BREAST CANCER PROGRESSING OR RELAPSING AFTER PREVIOUS ENDOCRINE THERAPYMedDRA version: 14.1Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2004-002371-16-IT
- Lead Sponsor
- ASTRAZENECA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Female
- Target Recruitment
- 720
Inclusion Criteria
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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What molecular mechanisms underlie fulvestrant's efficacy in estrogen receptor positive advanced breast cancer?
How does fulvestrant 500 mg compare to 250 mg in terms of clinical outcomes for postmenopausal patients with hormone-resistant breast cancer?
Which biomarkers are associated with response to fulvestrant in endocrine therapy-relapsed breast cancer patients?
What are the key adverse events reported in phase III trials of fulvestrant and how can they be managed in clinical practice?
How does fulvestrant compare to other selective estrogen receptor downregulators in treating advanced breast cancer after endocrine therapy?