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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.
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
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
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
Timepoint [2] 0 0
Every 8 weeks until progression or discontinuation
Secondary outcome [3] 0 0
Clinical Benefit Rate
Timepoint [3] 0 0
Every 8 weeks until progression or discontinuation
Secondary outcome [4] 0 0
Duration of Clinical Benefit
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
Sex
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
1/03/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2016
Sample size
Target
Accrual to date
Final
75
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
Trial website
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

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