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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00454805
Registration number
NCT00454805
Ethics application status
Date submitted
29/03/2007
Date registered
2/04/2007
Date last updated
3/08/2016
Titles & IDs
Public title
AZD2171 in Addition to Fulvestrant in Patients With Advanced Breast Cancer.
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Scientific 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
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Secondary ID [1]
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D8480C00007
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AZD2171
Treatment: Drugs - Fulvestrant
Active comparator: 2 - Fulvestrant Monotherapy
Experimental: 3 - AZD2171 + Fulvestrant
Treatment: Drugs: AZD2171
Oral tablet
Treatment: Drugs: Fulvestrant
intramuscular injection
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival
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Assessment method [1]
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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.
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Timepoint [1]
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RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.
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Secondary outcome [1]
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Objective Response Rate
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Assessment method [1]
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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
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Timepoint [1]
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RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.
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Secondary outcome [2]
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Duration of Response
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Assessment method [2]
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Number of days from date of response (complete/partial based on RECIST) to date of progression
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Timepoint [2]
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Every 8 weeks until progression or discontinuation
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Secondary outcome [3]
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Clinical Benefit Rate
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Assessment method [3]
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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.
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Timepoint [3]
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Every 8 weeks until progression or discontinuation
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Secondary outcome [4]
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Duration of Clinical Benefit
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Assessment method [4]
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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.
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Timepoint [4]
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Every 8 weeks until progression or discontinuation
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
130
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2016
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Sample size
Target
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Accrual to date
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Final
75
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Fitzroy
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Recruitment hospital [2]
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Research Site - Parkville
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Recruitment hospital [3]
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Research Site - Perth
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Recruitment hospital [4]
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Research Site - Waratah
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Recruitment postcode(s) [1]
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- Fitzroy
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Recruitment postcode(s) [2]
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- Parkville
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Recruitment postcode(s) [3]
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- Perth
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Recruitment postcode(s) [4]
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- Waratah
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Hawaii
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Country [4]
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United States of America
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State/province [4]
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New York
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Country [5]
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Brazil
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State/province [5]
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Belo Horizonte
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Country [6]
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Brazil
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State/province [6]
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Curitiba
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Country [7]
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Brazil
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State/province [7]
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Fortaleza
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Country [8]
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Brazil
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State/province [8]
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Porto Alegre
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Country [9]
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Brazil
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State/province [9]
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Santro Andre
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Country [10]
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Brazil
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State/province [10]
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São Paulo
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00454805
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Trial related presentations / publications
Hyams DM, Chan A, de Oliveira C, Snyder R, Vinholes J, Audeh MW, Alencar VM, Lombard J, Mookerjee B, Xu J, Brown K, Klein P. Cediranib in combination with fulvestrant in hormone-sensitive metastatic breast cancer: a randomized Phase II study. Invest New Drugs. 2013 Oct;31(5):1345-54. doi: 10.1007/s10637-013-9991-2. Epub 2013 Jun 26.
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Public notes
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Contacts
Principal investigator
Name
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Bijoyesh Mookerjee, MD
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Address
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AstraZeneca
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00454805
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