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: NCT00305448
• Lead Sponsor: AstraZeneca

Brief Summary

This study will assess the relationship between fulvestrant dose and efficacy, and determine the dosing regimen as a second line therapy for Japanese postmenopausal women with oestrogen receptor positive advanced breast cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-20
• Study First Submitted QC: 2006-03-20
• Study First Posted: 2006-03-22
• Primary Completion: 2008-03
• Results First Submitted: 2009-03-17
• Results First Submitted QC: 2011-07-29
• Results First Posted: 2011-08-29
• Status Verified: 2012-02
• Study Completion: 2012-02
• Last Update Submitted: 2012-02-14
• Last Update Posted: 2012-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 143

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

Exclusion Criteria

• Treatment with more than one previous regimen of systemic anticancer therapy other than endocrine therapy for advanced breast cancer
• Treatment with more than one previous regimen of endocrine therapy for advanced breast cancer
• An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Fulvestrant	Fulvestrant 250 mg intramuscular injection
3	Fulvestrant	Fulvestrant 500 mg
2	Fulvestrant	Fulvestrant 250mg (Plus 250mg Loading Regimen)

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	baseline and every 12 weeks (+/- 2weeks) from randomization data up to data cut-off (19th march 2008)	An objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR). A patient has best overall response of CR if she had overall response of CR or PR on one visit and met the confirmation criteria per RECIST. ORR is defined as percentage of patients with objective response.; Each patient with measurable disease at baseline was assessed for OR from the sequence of Response Evaluation Criteria in Solid Tumors (RECIST) scan data up to data cut-off. RECIST scans were performed every 12 weeks (+/- 2weeks) from randomization

Secondary Outcome Measures

Name	Time	Method
Time to Progression (TTP)	every 12 weeks from randomization (+/- 2 weeks) until data cut-off (19th march 2008)	Time (in days) from randomization until objective disease progression or death (in the absence of objective progression). RECIST tumour assessments carried out every 12 weeks from randomization (+/- 2 weeks) until data cut-off on 19th March 2008.
Duration of Response (DoR)	RECIST tumour assessments carried out every 12 weeks from randomisation (+/- 2 weeks) until data cut-off on19th March 2008.	Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieved a confirmed Complete Response or confirmed Partial Response.
Clinical Benefit Rate (CBR)	every 12 weeks(+/- 2 weeks) from randomization to data up to data cut-off, 19th March 2008.	A Clinical Benefit (CB) responder is defined as a patient having a best overall response of Complete response (CR), Partial Response (PR) or Stable disease (SD) provided SD (or better) was present = 154 days from randomization (ie SD = 24 weeks with the 2 week RECIST assessment time window allowed). The Clinical Benefit Rate is the percentage of patients with CB.
Pharmacokinetic Parameter: Mean Population Clearance, a Measure of the Efficiency With Which Fulvestrant is Eliminated From the Body	Baseline to 12 weeks	The measure of dispersion for mean population clearance is based on the estimated inter-individual variance
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	The measure of dispersion for volume of distribution is based on the inter-individual variance estimated for the apparent volume of plasma into which Fulvestrant distributes

Trial Locations

Locations (1)

Research Site; 🇯🇵 Shizuoka, Japan