A Clinical Trial to Compare Efficacy and Tolerability of Fulvestrant 250mg, 250mg Plus 250mg Loading Regimen and 500mg

Phase 2

Completed

• Conditions: Advanced Breast Cancer; Metastatic Breast Cancer
• Interventions: Drug: Fulvestrant

• Registration Number: NCT00313170
• Lead Sponsor: AstraZeneca

Brief Summary

This study will assess the relationship between fulvestrant dose and efficacy in postmenopausal women with oestrogen receptor positive advanced breast cancer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-04-10
• Study First Submitted QC: 2006-04-11
• Study First Posted: 2006-04-12
• Study Start: 2006-05-30
• Primary Completion: 2008-06-13
• Results First Submitted: 2009-06-10
• Results First Submitted QC: 2011-07-29
• Results First Posted: 2011-08-29
• Study Completion: 2019-03-13
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-17
• Last Update Posted: 2020-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 144

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 (woman who has stopped having menstrual periods)

Exclusion Criteria

• Treatment with more than one previous regimen of systemic anticancer therapy other than endocrine therapy for advanced BC.
• Treatment with more than one previous regimen of endocrine therapy for advanced BC.
• An existing condition that prevents compliance.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Fulvestrant	Fulvestrant 250 mg (intramuscular injection 250 mg)
2	Fulvestrant	Fulvestrant 250 mg (+ 250 mg loading regimen)
3	Fulvestrant	Fulvestrant 500 mg (intramuscular injection 500 mg)

Primary Outcome Measures

Name	Time	Method
Objective Response (ORR)	The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.	Objective response rate was defined as percentage of patients with either complete response (CR - disappearance of all target lesions) or partial response (PR - at least 30% decrease in the sum of diameters of target lesions). All patients were to be followed up every 12 weeks for progression, defined by response evaluation criteria in solid tumors (RECIST v1.1).

Secondary Outcome Measures

Name	Time	Method
Time to Progression (TTP)	The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.	Time from randomisation until objective disease progression or death (in the absence of objective progression) using the Kaplan-Meier method. RECIST tumor assessments were carried out every 12 weeks until progression.
Duration of Response (DoR)	The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.	DoR was defined as the time from date of first documentation of the response (CR or PR) until the date of disease progression or death from any cause.
Clinical Benefit Rate (CBR)	The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.	CBR was defined as the proportion of all randomised patients who had clinical benefit (response of CR, PR or SD\>=24 weeks.
Pharmacokinetic Parameter: Mean Population Clearance, a Measure of the Efficiency With Which Fulvestrant is Eliminated From the Body	Baseline to 12 weeks	A 2-compartment model with a 1st order absorption and 1st order elimination process was fitted to the fulvestrant concentration-time data. Relative standard error is reported for the mean.
Pharmacokinetic Parameter: Mean Volume of Distribution at Steady State, a Measure of the Apparent Volume in the Body Into Which Fulvestrant Distributes	Baseline to 12 weeks	A 2-compartment model with a 1st order absorption and 1st order elimination process was fitted to the fulvestrant concentration-time data. Relative standard error is reported for the mean. The mean estimate of volume of distribution at steady state was reported as the sum of V1/F and V2/F in the clinical study report.

Trial Locations

Locations (1)

Research Site; 🇹🇷 Istanbul, Turkey