Maintaining Skeletal Health in Postmenopausal Women With Surgically Resected Stage I-IIIa Hormone-receptor Positive Breast Cancer Who Are Receiving Anastrozole, Through the Use of Alendronate as Determined by the Osteoporosis Australia Bone Maintenance Algorithm

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