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Trial registered on ANZCTR


Registration number
ACTRN12605000498695
Ethics application status
Approved
Date submitted
19/09/2005
Date registered
23/09/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Phase II Trial of Anastrozole with Celecoxib as First-Line Therapy for Postmenopausal Women with Hormone Receptor Positive Breast Cancer
Scientific title
A Phase II Trial of Anastrozole with Celecoxib as First-Line Therapy for Postmenopausal Women with Hormone Receptor Positive Breast Cancer
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 622 0
Condition category
Condition code
Cancer 695 695 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Anastrozole 1mg/day and Celecoxib 400 mg b.i.d
Intervention code [1] 647 0
Treatment: Drugs
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 847 0
To measure the objective response rate of breast cancer to the combination of Anastrozole and celecoxib
Timepoint [1] 847 0
Secondary outcome [1] 1684 0
To record the toxicities and feasibility of delivering the regimen.
Timepoint [1] 1684 0
Secondary outcome [2] 1685 0
To ascertain the time to progression and overall survival of patients on this regimen.
Timepoint [2] 1685 0

Eligibility
Key inclusion criteria
Patients with histological or cytological evidence of breast cancer which has become metastatic Postmenopausal women as defined byWomen > 50 years old with no spontaneous menses for at least 1 yearWomen > 50 years old with non spontaneous menses within 1 year and FSH/LH in the postmenopausal rangeAny age after a bilateral oophorectomy or radiation castration with amenorrhea lasting at least 3 monthsEstrogen and/or progesterone receptor positive as defined by the reference laboratoryPatients who are deemed by their clinician to have metastatic disease eligible for hormone treatment alone (that is not rapidly progressing visceral disease or lymphangitis)Patients who have measurable disease by the RECIST criteria or bone disease.Patients with a WHO performance status of 0-2Life expectancy should be greater than 12 weeksPatients should have adequate bone marrow reservePatients should have adequate renal function with calculated creatinine clearance 60 ml/minPatients should have adequate liver function with Bilirubin < 1.5x upper limit of normal and transaminases < 2.5x upper limit of normalPatients must give written informed consent
Minimum age
18 Years
Maximum age
Not stated
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Premenopausal patientsLocally advanced diseasePrior systemic hormone or chemotherapy for metastatic breast cancerNo other investigational systemic drugs within 1 month of therapyPatients who have received aromatase inhibitors as part of adjuvant therapy and have developed metastatic disease within 12 months of completing adjuvant therapyPatients who are anti-coagulated e.g. on warfarinPatients who are already receiving celecoxib, rofecoxib or another non-steroidal anti-inflammatory drug, lithium, glucocorticoids, diuretics, ACE inhibitors or fluconazole. Low dose aspirin may be taken for cardiovascular prophylaxis, but these patients should be monitored closely for any gastrointestinal complications. Patients with newly diagnosed cerebral metastases. Previously treated, asymptomatic cerebral metastases are acceptableOther concurrent or prior malignancies except curatively treated carcinoma of the cervix and non-melanoma skin cancer or patients with any previous who have had no recurrent disease for 5 years or where the prior cancer was contralateral breast cancerPatients who have a known hypersensitivity to celecoxib or any other component of celecoxib, or patients who have experienced asthma, urticaria or allergic-type reactions after taking aspirin, other NSAIDs or sulpha drugs such as the sulphonamides. Patients with a history of gastrointestinal bleeding or a history of NSAID induced ulcer. Patients with a past history of a previous ulcer (other than the above causes) may be included at the discretion of the investigator but should be on a proton pump inhibitor.Patients with other concomitant severe systemic disease such as cardiac failure or myocardial infarction within the previous 3 months, uncontrolled hypertension (BP>150/100) or arrhythmia, renal disease, hepatic failure or respiratory disease.

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)
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)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
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)

Funding & Sponsors
Funding source category [1] 770 0
Commercial sector/Industry
Name [1] 770 0
Astra Zeneca
Address [1] 770 0
Country [1] 770 0
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Country
Australia
Secondary sponsor category [1] 631 0
None
Name [1] 631 0
none
Address [1] 631 0
Country [1] 631 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2016 0
Royal Adelaide Hospital
Ethics committee address [1] 2016 0
Ethics committee country [1] 2016 0
Australia
Date submitted for ethics approval [1] 2016 0
Approval date [1] 2016 0
Ethics approval number [1] 2016 0

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

Contacts
Principal investigator
Name 35351 0
Address 35351 0
Country 35351 0
Phone 35351 0
Fax 35351 0
Email 35351 0
Contact person for public queries
Name 9836 0
Professor Ian Olver
Address 9836 0
Royal Adelaide Hospital (RAH) Cancer Centre
Royal Adelaide Hospital
Level 7
East Wing
North Tce
Adelaide SA 5000
Country 9836 0
Australia
Phone 9836 0
+61 8 82225577
Fax 9836 0
+61 8 82224358
Email 9836 0
ian.olver@adelaide.edu.au
Contact person for scientific queries
Name 764 0
Nancy Olszewski
Address 764 0
Royal Adelaide Hospital
Level 7
East Wing
North Tce
Adelaide SA 5000
Country 764 0
Australia
Phone 764 0
+61 8 82224765
Fax 764 0
+61 8 82224358
Email 764 0
nolszews@mail.rah.sa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary