Bisphosphonate and Anastrozole Trial - Bone Maintenance Algorithm Assessment (BATMAN)
Breast Cancer

About this trial
This is an interventional prevention trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- Sydney South West Area Health Service
- Tweed Hospital
- Box Hill Hospital
- Maroondah Breast Clinic
- St Vincent's Health
- Barwon Health
- St John of God Healthcare
- South West Healthcare
Arms of the Study
Arm 1
Other
Anastrozole and alendronate
Patients will receive anastrozole for 5 years and alendronate for 3 years or anastrozole and alendronate treatment for 5 years.