Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000904279
Ethics application status
Approved
Date submitted
12/10/2009
Date registered
19/10/2009
Date last updated
21/11/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Study of changes in cancer tissue induced by treatment with bevacizumab in metastatic breast cancer
Scientific title
Study of molecular changes induced by treatment with bevacizumab in metastatic breast cancer
Secondary ID [1] 1114 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
metastatic breast cancer 251988 0
Condition category
Condition code
Cancer 252181 252181 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Biopsy of tissue from recurrent or metastatic breast cancer (only skin, lymph node, breast tumor biopsies allowed) on day 0, administration of bevacizumab 10mg/kg on day 1 (intravenously infused over 90 min) and re-biopsy on day 14.
Intervention code [1] 241400 0
Treatment: Drugs
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 253052 0
changes in the expression of certain genes induced by a single dose of bevacizumab. Changes in gene expression will be assessed with the use of superarray technology (commercially available through Bioscience Corporation). Genes of interest are the Notch pathway and angiogenesis pathway (sets of genes available commercially through Bioscience Corporation)
Timepoint [1] 253052 0
14 days
Secondary outcome [1] 257872 0
changes of plasma levels of certain angiogenic markers vascular endothelial growth factor (VEGF), soluble vascular endothelial growth factor receptor (sVEGFR), angiopoietins, basic fibroblast growth factor (bFGF), Tie-1/2, angiostatin, circulating endothelial cells (CEC)
Timepoint [1] 257872 0
14 days

Eligibility
Key inclusion criteria
histologically proven metastatic breast cancer, locally accessible disease (breast tumor, skin mets, lymph node mets), Performance status (PS) 0-1, normal liver and kidney function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
history of thrombotic disease, uncontrolled brain metastases, pregnancy, lactation, prior bevacizumab exposure, recent surgery (within 4 weeks), active bleeding, active infection, unhealed wound, use of anticoagulants in therapeutic doses

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Detailed discussion with all eligible patients
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 2264 0
Greece
State/province [1] 2264 0

Funding & Sponsors
Funding source category [1] 243862 0
Charities/Societies/Foundations
Name [1] 243862 0
Hellenic Association for Cancer Research
Country [1] 243862 0
Greece
Primary sponsor type
Individual
Name
Georgios Kesisis
Address
44 Gennimata str
55134-Kalamaria
Thessaloniki
Greece
Country
Greece
Secondary sponsor category [1] 237210 0
Individual
Name [1] 237210 0
Konstantinos Papazisis
Address [1] 237210 0
2 Al Simeonidi str
7th Floor
3rd department of Medical Oncology
54007
Thessaloniki
Country [1] 237210 0
Greece

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243985 0
Theagenion Ethics Committee
Ethics committee address [1] 243985 0
Ethics committee country [1] 243985 0
Greece
Date submitted for ethics approval [1] 243985 0
Approval date [1] 243985 0
06/02/2009
Ethics approval number [1] 243985 0
1421-10/02/2009

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30376 0
Address 30376 0
Country 30376 0
Phone 30376 0
Fax 30376 0
Email 30376 0
Contact person for public queries
Name 13623 0
Georgios Kesisis
Address 13623 0
44 Gennimata str
55134, Kalamaria
Thessaloniki
Country 13623 0
Greece
Phone 13623 0
+306974316307
Fax 13623 0
Email 13623 0
[email protected]
Contact person for scientific queries
Name 4551 0
Georgios Kesisis
Address 4551 0
44 Gennimata str
55134, Kalamaria
Thessaloniki
Country 4551 0
Greece
Phone 4551 0
+306974316307
Fax 4551 0
Email 4551 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.