Androgen Therapy for Breast Cancer Patients With Aromatase Inhibitor Induced Side-Effects

Inclusion Criteria:

* Provision of written informed consent
* Undergone a total mastectomy, a lumpectomy or a quadrantectomy for primary breast cancer +/-chemo, +/-radiotherapy
* Have commenced anastrozole therapy within the previous 6 months
* Presence of node negative or positive disease
* Receptor-positive tumors, defined as ER ≥10% of the tumor cells positive by immunocytochemical evaluation
* Postmenopausal whether induced by surgery, radiotherapy (chemotherapy-induced amenorrhea may be difficult to determine they may be amenorrhoeic but still have functioning ovaries), or by being naturally amenorrhoeic, for 1 year or more if younger than 50 and for 6 months if 50 or older
* Postmenopausal levels of FSH/LH/E2 (follicle stimulating hormone, luteinizing hormone, oestrogen) according to the definition of "postmenopausal range" for the laboratory involved
* Have developed arthralgia and associated joint symptoms whilst being treated with anastrozole with a score of 40mm or greater on a pain and stiffness 100mm VAS
* WBC ≥ 3.0 x 109/L, granulocytes ≥ 1.5 X 109/L and platelets ≥ 100 x 109/L.
* AST/SGOT or ALT/SGPT ≤ 3 times ULN Serum creatinine ≤ 2 times ULN

Exclusion Criteria:

* Presence of metastatic disease
* Diabetes mellitus or glucose intolerance defined as a fasting glucose \>6mmol/l
* Previous or concomitant other (non-breast cancer) malignancy within the previous 5 years
* Presence of other non-malignant systemic diseases which may prevent prolonged follow-up
* History of coronary artery disease or no history of previous coronary heart disease but at least two other coronary heart disease risk factors: LDL ≥8.8 mg/dL OR if fewer than two other coronary heart disease risk factors: LDL ≥10.45 mg/dL or total fasting cholesterol ≥ 13.2 mg/dL
* Patients on hormone replacement therapy (HRT) within 4 weeks before trial treatment was initiated
* Patients on breast cancer chemoprevention with anti-oestrogens if less than 18 months between stopping and diagnosis of breast cancer
* Are at risk of transmitting Human Immunodeficiency Virus or viral hepatitis via infected blood
* Known hypersensitivity to any component of testosterone
* Unable to comply with study requirements
* Taking the following concomitant medications at the screening visit-bisphosphonate, anti-cancer treatment other than anastrozole (this includes Herceptin).
* Prolonged systemic corticosteroid treatment, except for topical applications (e.g. for rash), inhaled sprays (e.g. for obstructive airways diseases), eye drops or local injections (e.g. intra-articular). Note: Short duration (\< 2 weeks) of systemic corticosteroids is allowed (e.g. for Chronic Obstructive Pulmonary Disease) but not within 1 month prior to randomisation.
* Any investigational drugs
* Systemic hormone replacement therapy
* Pregnant or lactating women
* Patients with history of fragility fracture or low BMD, osteoporosis or osteopenia
* Known liver disease