AZD2171 in Addition to Fulvestrant in Patients With Advanced Breast Cancer.

Study Overview
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Brief Summary
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The purpose of this study is to determine whether AZD2171 can effectively improve time to tumour progression when added to fulvestrant in patients with advanced hormone sensitive breast cancer who progressed on prior hormonal therapy.

Official Title
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A Phase II, Double-Blind, Placebo Controlled, Randomized Study to Assess the Efficacy and Safety of AZD2171 in Combination With Fulvestrant vs Fulvestrant Alone in Hormone Sensitive (ER+ve or PgR+ve) Post Menopausal Metastatic Breast Cancer Patients

Conditions
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Advanced Breast Cancer

Intervention / Treatment
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* Drug: AZD2171
* Drug: Fulvestrant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Females with histological/cytological confirmation of hormone sensitive breast cancer with evidence of metastatic disease One or more evaluable lesions Exclusion Criteria: Prior hormonal therapy with fulvestrant More than one course of prior systemic cytotoxic chemotherapy for metastatic breast cancer Prior biologic therapy for ABC including Anti-VEGF agents Radiation therapy within 4 weeks prior to provision of consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 130 Years

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 |
| --- | --- |
| Active Comparator: 2<br>Fulvestrant Monotherapy | Drug: Fulvestrant<br>* intramuscular injection<br>* Other names: ZD9238;|
| Experimental: 3<br>AZD2171 + Fulvestrant | Drug: AZD2171<br>* Oral tablet<br>* Other names: Recentin;Drug: Fulvestrant<br>* intramuscular injection<br>* Other names: ZD9238;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression. | RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate | Best objective tumour response (based on Response Evaluation Criteria in Solid Tumours (RECIST)) during the study for patients with measurable disease. Best objective tumour response defined as: Complete Response (CR) Disappearance of all target lesions Partial response (PR) At least a 30% decrease in the sum of longest diameters (LDs) of target lesions, taking as reference the baseline sum of LDs. Progression (PD) At least a 20% increase in the sum of LDs of target lesions, taking as reference the smallest sum of LDs since treatment started (including the baseline sum of LDs) and at least 5 mm increase. Stable disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD | RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest. | 
| Duration of Response | Number of days from date of response (complete/partial based on RECIST) to date of progression | Every 8 weeks until progression or discontinuation | 
| Clinical Benefit Rate | Clinical Benefit is defined as the number of patients having a best overall tumour response of CR/PR or SD for ≥6 months. The Clinical Benefit rate is defined as the number of responders divided by the number in the Intention-to-treat (ITT) analysis set: responder=overall best response of complete response (CR)/partial response (PR) or stable disease (SD) for at least 6 months (calculated from the date of randomisation) as defined by RECIST criteria at any point prior to the data cut-off. | Every 8 weeks until progression or discontinuation | 
| Duration of Clinical Benefit | Number of days from date of clinical benefit to date of progression. Clinical benefit is defined as having a best overall tumour response of CR/PR or SD for ≥6 months. | Every 8 weeks until progression or discontinuation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Breast Cancer