AZD2171 in Addition to Fulvestrant in Patients With Advanced Breast Cancer
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.
|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:||June 2014|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Active Comparator: 2
AZD2171 + Fulvestrant
Other Name: RecentinDrug: Fulvestrant
|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|
|Miami, Florida, United States|
|United States, Hawaii|
|Honolulu, Hawaii, United States|
|United States, New York|
|New York, New York, United States|
|Australia, New South Wales|
|Waratah, New South Wales, Australia|
|Fitzroy, Victoria, Australia|
|Parkville, Victoria, Australia|
|Australia, Western Australia|
|Perth, Western Australia, Australia|
|Fortaleza, CE, Brazil|
|Belo Horizonte, MG, Brazil|
|Curitiba, PR, Brazil|
|Porto Alegre, RS, Brazil|
|Santro Andre, SP, Brazil|
|Sao Paulo, SP, Brazil|
|São Paulo, SP, Brazil|
|Study Director:||Bijoyesh Mookerjee, MD||AstraZeneca|