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

• Status: Unknown status
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to evaluate whether increasing blood levels of androgen can reduce some of the side-effects of anti-estrogen therapy (Arimidex)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chavah Pty Ltd; Havah Therapeutics Pty Ltd
• Collaborator: AstraZeneca
• Treatments: Anastrozole; Aromatase Inhibitors; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

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