AZD2171 in Addition to Fulvestrant in Patients With Advanced Breast Cancer
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- Progression Free Survival [ Time Frame: RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest. ] [ Designated as safety issue: No ]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.
- Objective Response Rate [ Time Frame: RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest. ] [ Designated as safety issue: No ]
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
- Duration of Response [ Time Frame: Every 8 weeks until progression or discontinuation ] [ Designated as safety issue: No ]Number of days from date of response (complete/partial based on RECIST) to date of progression
- Clinical Benefit Rate [ Time Frame: Every 8 weeks until progression or discontinuation ] [ Designated as safety issue: No ]
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 [ Time Frame: Every 8 weeks until progression or discontinuation ] [ Designated as safety issue: No ]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.
|Study Start Date:||March 2007|
|Estimated Study Completion Date:||December 2016|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Active Comparator: 2
AZD2171 + Fulvestrant
Other Name: RecentinDrug: Fulvestrant
Please refer to this study by its ClinicalTrials.gov identifier: NCT00454805
|United States, California|
|Burbank, California, United States|
|Los Angeles, California, United States|
|Palm Springs, California, United States|
|United States, Florida|
|Boca Raton, Florida, United States|
|United States, Hawaii|
|Honolulu, Hawaii, United States|
|United States, New York|
|New York, New York, United States|
|Belo Horizonte, Brazil|
|Porto Alegre, Brazil|
|Santro Andre, Brazil|
|São Paulo, Brazil|
|Study Director:||Bijoyesh Mookerjee, MD||AstraZeneca|