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Faslodex™ (fulvestrant) Clinical Trial report summaries

Faslodex™ (fulvestrant) is a hormonal treatment for hormone receptor-positive metastatic breast cancer in postmenopausal women whose disease has returned or progressed following antiestrogen therapy.

Please consult the prescribing information for the country concerned for guidance on the approved use of Faslodex™ (fulvestrant).

Study NumberCompleted Clinical Trial Report Summaries

9238HQ/0002

A randomized study to evaluate tolerance, pharmacokinetics, and short term efficacy of seven doses of the short –acting formulation of ICI 182,780 in women prior to surgery for primary breast cancer. 

9238IL/0004

An open Phase II Study to determine if Partial or Complete Responses can be achieved with the Slow Release formulation of a Pure Anti-oestrogen (ICI 182,780) in Post-menopausal Women with Advanced Breast Cancer who have Relapsed on Tamoxifen Therapy

9238IL/0018

A Partially-Blind, Randomised, Multi-centre Trial to Compare the Anti-Tumour Effects, Pharmacokinetics and Tolerability of 50 mg, 125 mg and 250 mg Single Doses of FASLODEX (Long-Acting ICI 182,780) with Tamoxifen and with Tamoxifen Placebo in Postmenopausal Women Prior to Surgery for Primary Breast Cancer

9238IL/0019

A Randomised, Placebo-Controlled, Dose-Ranging Trial Comparing ICI 182,780 with ZOLADEX™ in Patients with Uterine Fibroids Awaiting Hysterectomy

9238IL/0020

An Open, Randomised, Multi-centre Trial Comparing the Efficacy and Tolerability of 125 mg and 250 mg FASLODEX™ (Long-acting ICI 182,780) with 1 mg ARIMIDEX™ (Anastrozole) in Postmenopausal Women with Advanced Breast Cancer

9238IL/0021

A Double-blind, Randomized, Multicenter Trial Comparing the Efficacy and Tolerability of 125 and 250 mg of FASLODEX™ (Long-acting ICI 182,780) With 1 mg of ARIMIDEX™ (Anastrozole) in Postmenopausal Women With Advanced Breast Cancer

9238IL/0025

A Double-blind, Randomised, Multi-centre Trial Comparing the Efficacy and Tolerability of 250 mg of FASLODEX (Long-acting ICI 182,780) with 20 mg NOLVADEX™ (Tamoxifen) in Postmenopausal Women with Advanced Breast Cancer

9238IL/0041

A double-blind, randomised, placebo-controlled trial to study the anti-tumour effects of 250 mg FASLODEX™ (fulvestrant) in oestrogen receptor-positive primary breast cancers in premenopausal women

9238IL/0042

A double blind, double-dummy, randomised, parallel groupmulticentre trial to compare the efficacy, tolerability, endometrial and bone effects of FASLODEX™ (fulvestrant) 250 mg monthly with NOLVADEX™ (tamoxifen) 20 mg daily when given as neoadjuvant treatment in post menopausal women with primary breast cancer  

D6997C00048

A Randomized, Double Blind, Multi-center Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) vs Exemestane (AROMASIN™) in Postmenopausal Women with Hormone Receptor-Positive Advanced Breast Cancer with Disease Progression after Prior Non-Steroidal Aromatase Inhibitor (AI) Therapy

D6997L00004

A double blind, double dummy, randomised, multicentre study to compare the efficacy and safety of Fulvestrant 250mg with Arimidex 1mg in the postmenopausal women with oestrogen receptor positive advanced breast cancer progressing or relapsing after previous antioestrogen therapy

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