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Trial registered on ANZCTR


Registration number
ACTRN12612000416897
Ethics application status
Approved
Date submitted
30/03/2012
Date registered
13/04/2012
Date last updated
11/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Sequential evaluation of tumours undergoing pre-operative therapy with aromatase inhibitors and metformin (setup-aim) a neo-adjuvant pilot study in operable hormone sensitive breast cancer in post menopausal women
Scientific title
Sequential evaluation of tumours undergoing pre-operative therapy with aromatase inhibitors and metformin (setup-aim) a neo-adjuvant pilot study in operable hormone sensitive breast cancer in post menopausal women
Secondary ID [1] 280242 0
None
Universal Trial Number (UTN)
Trial acronym
SETUP AIM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hormone positive operable breast cancer 286197 0
Condition category
Condition code
Cancer 286404 286404 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2 weeks of metformin (oral tablets, 1 gm per day) followed by 2 weeks of metformin (oral tablets, 1gm per day) plus aromatase inhibitor (oral tablets 1 mg Arimidex (trade name) or oral tablets 2.5 mg Femara (trade name)) all prior to surgery
Intervention code [1] 284594 0
Treatment: Drugs
Comparator / control treatment
2 weeks of metformin (oral tablets, 1gm per day) followed by 2 weeks of aromatase inhibitor alone (oral tablets 1mg Arimidex (trade name) or oral tablets 2.5 mg Femara (trade name)
Control group
Active

Outcomes
Primary outcome [1] 286861 0
Reduction in tumour tissue Ki67 level (proliferative index)
Timepoint [1] 286861 0
At surgery to be performed 4 weeks after comencing treatment
Secondary outcome [1] 296815 0
Imaging responses (mammogram, ultrasound, MRI)
Timepoint [1] 296815 0
At surgery performed 4 weeks after commencing treatment

Eligibility
Key inclusion criteria
Stage 1 or 2 operable invasive breast cancer. Estrogen receptor positive (>10% cells)
Post-menopausal female
Histologically proven invasive adenocarcinoma of the breast through either a core needle biopsy or incisional biopsy Excisional biopsy will not be allowed. Tumour must be confined to either the breast or to the breast and ipsilateral axilla. A complete metastatic staging work-up will be performed prior to definitive surgery, as clinically indicated.
Age > =18 years.
Karnofsky Performance status index > =80%.
Laboratory requirements: (within 28 days prior to registration)

Haematology:
Neutrophils > =1.5 x 109/L
Platelets >=100 x 109/L
Haemoglobin > =10 g/dL
Hepatic function:
Total bilirubin < =1 UNL (patients with a well documented history of Gilbert’s Syndrome are eligible)
ASAT (SGOT) and ALAT (SGPT) < =2.5 UNL
Alkaline phosphatase < =5 UNL
Renal function:
Creatinine <= 175 micromol/L (2 mg/dL)
Negative pregnancy test (urine or serum) within 7 days prior to registration for all women of childbearing potential.
Patients must be postmenopausal defined as:
Age >50 y and amenorrheic for 6 months or more
Age <50 y and amenorrheic for 12 months or more
Prior bilateral oophorectomy
Prior hysterectomy and has post menopausal levels of FSH and LH per local institutional standards
Age >55 y and prior hysterectomy
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Prior or concurrent systemic anticancer therapy for breast cancer (immunotherapy, hormone therapy, biological, or chemotherapy).
Prior or concurrent radiation therapy for breast cancer.
Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment.
M1 breast cancer.
Diabetic patients currenly treated with metformin. Diet controlled diabetic patients are eligible.
Other serious illness or medical condition:
Congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias, history of significant neurological or psychiatric disorders including psychotic disorders,
dementia or seizures that would prohibit the understanding and giving of informed consent,
active uncontrolled infection,
active peptic ulcer
Current history of any neoplasm other than breast carcinoma.
Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment should be stopped at least 4 weeks prior to registration.
Concurrent treatment with other experimental drugs.
Current therapy with any hormonal agent such as raloxifene, tamoxifen or other selective oestrogen receptor modulators (SERMs), either for osteoporosis or prevention. Patients must have discontinued these agents at least four weeks prior to registration.
Known allergy reactions or excipients used in the study.

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)
Once informed consent obtained, patients will be allocated to either arm in a 1 to 1 fashion
computer generated randomisation envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by computer software (i.e., computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2012
Actual
30/07/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 285012 0
Government body
Name [1] 285012 0
Victorian Breast Cancer Research Consortium
Country [1] 285012 0
Australia
Primary sponsor type
Individual
Name
Dr Vinod Ganju
Address
865 Centre Rd
East Bentleigh Victoria 3165
Country
Australia
Secondary sponsor category [1] 283877 0
None
Name [1] 283877 0
Address [1] 283877 0
Country [1] 283877 0
Other collaborator category [1] 260678 0
Commercial sector/Industry
Name [1] 260678 0
Medical Imaging Australia
Address [1] 260678 0
871 Centre Rd
East Bentleigh Victoria 3165
Country [1] 260678 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287016 0
Southern Health Human Research and Ehtics Committee
Ethics committee address [1] 287016 0
Ethics committee country [1] 287016 0
Australia
Date submitted for ethics approval [1] 287016 0
02/02/2012
Approval date [1] 287016 0
24/04/2012
Ethics approval number [1] 287016 0
12009A

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

Contacts
Principal investigator
Name 33999 0
A/Prof Vinod Ganju
Address 33999 0
865 Centre Rd East Bentleigh VIC 3165
Country 33999 0
Australia
Phone 33999 0
61399288120
Fax 33999 0
Email 33999 0
vg@paso.com.au
Contact person for public queries
Name 17246 0
peter midolo
Address 17246 0
865 centre rd
East Bentleigh
Victoria
3165
Country 17246 0
Australia
Phone 17246 0
61399288195
Fax 17246 0
61399288543
Email 17246 0
peter.midolo@monashhealth.org
Contact person for scientific queries
Name 8174 0
kristy brown
Address 8174 0
Prince Henry's Institute
Monash Medical Centre
246 Clayton Rd
Clayton Victoria 3168
Country 8174 0
Australia
Phone 8174 0
61395943249
Fax 8174 0
61395946125
Email 8174 0
kristy.brown@princehenrys.org

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.