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

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Study to Evaluate the Efficacy and Tolerability of Fulvestrant 250mg, 250mg (Plus 250mg Loading Regimen) and 500mg in Postmenopausal Women With ER +ve Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy

Conditions
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Advanced Breast Cancer, Metastatic Breast Cancer

Intervention / Treatment
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* Drug: Fulvestrant
* Drug: Fulvestrant


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Fulvestrant 250 mg intramuscular injection | Drug: Fulvestrant<br>* 250 intramuscular injection<br>* Other names: ZD9238;|
| Experimental: 2<br>Fulvestrant 250mg (Plus 250mg Loading Regimen) | Drug: Fulvestrant<br>* 250 intramuscular injection<br>* Other names: ZD9238;|
| Experimental: 3<br>Fulvestrant 500 mg | Drug: Fulvestrant<br>* 500 mg intramuscular injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) | 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 | baseline and every 12 weeks (+/- 2weeks) from randomization data up to data cut-off (19th march 2008) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Progression (TTP) | 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. | every 12 weeks from randomization (+/- 2 weeks) until data cut-off (19th march 2008) | 
| Duration of Response (DoR) | 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. | RECIST tumour assessments carried out every 12 weeks from randomisation (+/- 2 weeks) until data cut-off on19th March 2008. | 
| Clinical Benefit Rate (CBR) | 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. | every 12 weeks(+/- 2 weeks) from randomization to data up to data cut-off, 19th March 2008. | 
| Pharmacokinetic Parameter: Mean Population Clearance, a Measure of the Efficiency With Which Fulvestrant is Eliminated From the Body | The measure of dispersion for mean population clearance is based on the estimated inter-individual variance | Baseline to 12 weeks | 
| Pharmacokinetic Parameter: Mean Volume of Distribution at Steady State, a Measure of the Apparent Volume in the Body Into Which Fulvestrant Distributes | 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 | Baseline to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oncology, cancer, breast cancer