None listed
Conditions
Interventions
Anastrozole 1mg/day and Celecoxib 400 mg b.i.d
Sponsors
Royal Adelaide Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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.
Outcome results
None listed