AZD2171 in Addition to Fulvestrant in Patients With Advanced Breast Cancer.
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|ClinicalTrials.gov Identifier: NCT00454805|
Recruitment Status : Completed
First Posted : April 2, 2007
Results First Posted : November 28, 2012
Last Update Posted : August 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Advanced Breast Cancer||Drug: AZD2171 Drug: Fulvestrant||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||April 2016|
Active Comparator: 2
AZD2171 + Fulvestrant
Other Name: Recentin
- Progression Free Survival [ Time Frame: 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.
- Objective Response Rate [ Time Frame: 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 PD
- Duration of Response [ Time Frame: Every 8 weeks until progression or discontinuation ]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 ]
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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|