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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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.
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
Secondary ID [1] 0 0
D8480C00007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival - 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.
Timepoint [1] 0 0
RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.
Secondary outcome [1] 0 0
Objective Response Rate - 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
Timepoint [1] 0 0
RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.
Secondary outcome [2] 0 0
Duration of Response - Number of days from date of response (complete/partial based on RECIST) to date of progression
Timepoint [2] 0 0
Every 8 weeks until progression or discontinuation
Secondary outcome [3] 0 0
Clinical Benefit Rate - 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.
Timepoint [3] 0 0
Every 8 weeks until progression or discontinuation
Secondary outcome [4] 0 0
Duration of Clinical Benefit - 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.
Timepoint [4] 0 0
Every 8 weeks until progression or discontinuation

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
Minimum age
18 Years
Maximum age
130 Years
Gender
Females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Fitzroy
Recruitment hospital [2] 0 0
Research Site - Parkville
Recruitment hospital [3] 0 0
Research Site - Perth
Recruitment hospital [4] 0 0
Research Site - Waratah
Recruitment postcode(s) [1] 0 0
- Fitzroy
Recruitment postcode(s) [2] 0 0
- Parkville
Recruitment postcode(s) [3] 0 0
- Perth
Recruitment postcode(s) [4] 0 0
- Waratah
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Hawaii
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
Brazil
State/province [5] 0 0
Belo Horizonte
Country [6] 0 0
Brazil
State/province [6] 0 0
Curitiba
Country [7] 0 0
Brazil
State/province [7] 0 0
Fortaleza
Country [8] 0 0
Brazil
State/province [8] 0 0
Porto Alegre
Country [9] 0 0
Brazil
State/province [9] 0 0
Santro Andre
Country [10] 0 0
Brazil
State/province [10] 0 0
São Paulo

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00454805
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bijoyesh Mookerjee, MD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications