Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000507684
Ethics application status
Approved
Date submitted
5/05/2014
Date registered
13/05/2014
Date last updated
10/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Pre-surgical aromatase inhibitor combined with non-steroidal anti inflammatory drug treatment in breast cancer
Scientific title
Randomised phase 2 trial of pre-surgical aromatase inhibitor, combined with non-steroidal anti inflammatory drug treatment or no additional treatment, in post-menopausal women with early stage operable breast cancer, to determine anti-proliferative response to aromatase inhibitor and effect of both agents on immune cell composition.
Secondary ID [1] 284543 0
NIL
Universal Trial Number (UTN)
Trial acronym
SAND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post menopausal breast cancer 291805 0
Condition category
Condition code
Cancer 292167 292167 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
in window of time between diagnosis and surgery, post-menopausal women with ER positive breast cancer will be treated with an aromatase inhibitor alone, letrozole 2.5mg daily oral tablet, or with aspirin 200mg twice daily, oral tablet, in an anti inflammatory dose. Adherence will be monitored by twice weekly nurse review, and blood estradiol levels.
Intervention code [1] 289302 0
Treatment: Drugs
Comparator / control treatment
control is aromatase inhibitor alone.
study arm is aromatase inhibitor plus aspirin
Control group
Active

Outcomes
Primary outcome [1] 292047 0
change in biological markers, including inflammation and proliferation, over 14 days of treatment. Pre- and post treatment tumour samples will be compared, and studied by immunohistochemistry for immune cell subsets, inflammatory cells, and tumour cell Ki67. Gene expression profiling using the same tumour samples will also be studied at a later stage.
Timepoint [1] 292047 0
14 days, or day of surgery if this is sooner.
Secondary outcome [1] 308071 0
safety of aspirin over 14 days, including peri-operatively, by twice weekly nurse assessment before and after surgery, using standard toxicity grading, recorded on CRF for specific side effects of interest.
Timepoint [1] 308071 0
During 14 days of treatment, on day of surgery and at 4-6 weeks

Eligibility
Key inclusion criteria
ER positive, stage 1-2 breast cancer, post-menopausal, no prior therapy
Minimum age
50 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
not post-menopausal, prior breast cancer, other illnesses,

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/06/2014
Actual
4/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 6029 0
New Zealand
State/province [1] 6029 0

Funding & Sponsors
Funding source category [1] 289171 0
Government body
Name [1] 289171 0
Health Research Council of New Zealand
Country [1] 289171 0
New Zealand
Primary sponsor type
University
Name
University of otago
Address
University of otago
PO Box 56
Dunedin 9054
New Zealand
Country
New Zealand
Secondary sponsor category [1] 287840 0
None
Name [1] 287840 0
Address [1] 287840 0
Country [1] 287840 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290947 0
HDEC
Ethics committee address [1] 290947 0
Ethics committee country [1] 290947 0
New Zealand
Date submitted for ethics approval [1] 290947 0
05/05/2014
Approval date [1] 290947 0
22/09/2014
Ethics approval number [1] 290947 0

Summary
Brief summary
Previous work suggests that the presence of inflammation in post-menopausal breast cancer is associated with a poor response to aromatase inhibitor treatment. Here, an anti inflammatory drug aspirin is given with the aromatase inhibitor, and the breast cancer will be sampled before and after the treatment, given in the window of time between diagnosis and definitive surgery
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48110 0
Prof Bridget Robinson
Address 48110 0
Oncology Service, and University of Otago Christchurch,
Christchurch Hospital
Riccarton Avenue
Christchurch 8140
Country 48110 0
New Zealand
Phone 48110 0
+64 3 3640020
Fax 48110 0
Email 48110 0
[email protected]
Contact person for public queries
Name 48111 0
Prof Bridget Robinson
Address 48111 0
Oncology Service
Christchurch Hospital
Riccarton Avenue
Christchurch 8140
Country 48111 0
New Zealand
Phone 48111 0
+64 3 3640020
Fax 48111 0
Email 48111 0
[email protected]
Contact person for scientific queries
Name 48112 0
Dr Anita Dunbier
Address 48112 0
University of Otago
Department of Biochemistry
PO Box 56
Dunedin 9054
Country 48112 0
New Zealand
Phone 48112 0
+64 3 4799258
Fax 48112 0
Email 48112 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.