AZD2171 in Addition to Fulvestrant in Patients With Advanced Breast Cancer.
- Registration Number
- NCT00454805
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 75
- Written informed consent
- Females with histological/cytological confirmation of hormone sensitive breast cancer with evidence of metastatic disease
- One or more evaluable lesions
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 AZD2171 AZD2171 + Fulvestrant 3 Fulvestrant AZD2171 + Fulvestrant 2 Fulvestrant Fulvestrant Monotherapy
- Primary Outcome Measures
Name Time Method Progression Free Survival RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest. 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.
- Secondary Outcome Measures
Name Time Method Clinical Benefit Rate Every 8 weeks until progression or discontinuation 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.Duration of Clinical Benefit Every 8 weeks until progression or discontinuation 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.
Objective Response Rate RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest. 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 PDDuration of Response Every 8 weeks until progression or discontinuation Number of days from date of response (complete/partial based on RECIST) to date of progression
Trial Locations
- Locations (1)
Research Site
🇧🇷São Paulo, Brazil