Status:
COMPLETED
Bisphosphonate and Anastrozole Trial - Bone Maintenance Algorithm Assessment
Lead Sponsor:
Barwon Health
Collaborating Sponsors:
AstraZeneca
Conditions:
Breast Cancer
Eligibility:
FEMALE
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the use of an oral bisphosphonate (alendronate) in preventing bone loss in postmenopausal women with early breast cancer who are receiving anastrozole therapy,...
Eligibility Criteria
Inclusion
- Postmenopausal
- Adequately diagnosed and treated Stage I-IIIa early breast cancer
- Oestrogen receptor and/or progesterone receptor positive breast cancer
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- Hormone replacement therapy (HRT) must be discontinued at least 2 weeks prior to registration
- Any prior tamoxifen taken for a total of 8 weeks or less
- Any prior anastrozole taken for a total of 4 weeks or less
- Anastrozole is clinically indicated to be the best adjuvant strategy
- Signed written informed consent
Exclusion
- Clinical or radiological evidence of distant spread of disease
- Prior treatment with bisphosphonates within the past 12 months
- Prior treatment with continuous systemic corticosteroids within the past 12 months
- Prior use of parathyroid hormone for more than 1 week
- Prior use of systemic sodium fluoride for \> 3 months during the past 2 years
- Currently treated with any drugs known to affect the skeleton
- Abnormal renal function (serum creatinine greater than or equal to 265.2 mmol/L)
- History of diseases with influence on bone metabolism. Patients with lactose intolerance are also excluded
- Delayed oesophageal emptying such as stricture or achalasia
- Hypersensitivity to alendronate or anastrozole
- Previous or concomitant malignancy within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix
- AST/SGOT and/or ALT/SGPT \> 3 x ULN in combination with other laboratory and clinical abnormalities indicating liver insufficiency
- Fracture due to minimal trauma, demonstrated radiologically
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
303 Patients enrolled
Trial Details
Trial ID
NCT00122356
Start Date
September 1 2005
End Date
March 1 2013
Last Update
March 13 2013
Active Locations (8)
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1
Sydney South West Area Health Service
Sydney, New South Wales, Australia, 2050
2
Tweed Hospital
Tweed Heads, New South Wales, Australia, 2485
3
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
4
Maroondah Breast Clinic
East Ringwood, Victoria, Australia, 3135