A Randomised, Open-Label, Parallel-Group, Multi-centre, Phase II Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500mg with Anastrozole (ARIMIDEX™) 1mg as First Line Hormonal Treatment for Postmenopausal Women with Hormone Receptor Positive Advanced Breast Cancer - FIRST STUDY
- Conditions
- Hormone Receptor Positive Advanced Breast CancerMedDRA version: 14.1Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2005-002868-28-IT
- Lead Sponsor
- ASTRAZENECA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 200
1.Postmenopausal woman
2.Documented positive hormone receptor status (ER +ve and/or PgR + ve) of primary or metastatic tumour tissue
3.Patients with metastatic or locally advanced disease not amenable to therapy with curative intent
4.Histological/cytological confirmation of breast cancer
5.Provision of written informed consent
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
1.Previous systemic therapy for advanced breast cancer.
2.Platelets < 100 ´ 109 / L
3.Total bilirubin > 1.5 ´ ULRR (Upper limit of reference range)
4.ALT or AST transamminase > 2.5 ´ ULRR if no demonstrable liver metastases or > 5 ´ ULRR in presence of liver metastases
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method